Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study.

Minor stroke, complex intervention, feasibility study, secondary prevention, follow-up care, hidden impairments. ALL Metrics - Views Downloads How to cite this article Crow J, Watt H, Wells M and Malhotra P. Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.13649.3) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente Select a format first ▬ ✚ Study Protocol Revised Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved] Jennifer Crow https://orcid.org/0000-0003-4692-1799 1,2, Hilary Watt3, Mary Wells4,5, Paresh Malhotra2Jennifer Crow https://orcid.org/0000-0003-4692-1799 1,2, Hilary Watt3, Mary Wells4,5, Paresh Malhotra2 PUBLISHED 26 Feb 2025 Author details Author details 1 Department of Occupational Therapy and Physiotherapy, Imperial College Healthcare NHS Trust, London, UK 2 Department of Brain Sciences, Imperial College London, London, England, UK 3 Department of Primary Care and Public Health, Imperial College London, London, England, UK 4 Department of Surgery and Cancer, Imperial College London, London, England, UK 5 Nursing Directorate, Imperial College Healthcare NHS Trust, London, UK 2 Department of Brain Sciences, Imperial College London, London, England, UK 3 Department of Primary Care and Public Health, Imperial College London, London, England, UK 4 Department of Surgery and Cancer, Imperial College London, London, England, UK 5 Nursing Directorate, Imperial College Healthcare NHS Trust, London, UK Jennifer Crow Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Hilary Watt Roles: Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Roles: Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Mary Wells Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Paresh Malhotra Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS Of the 150 000 people per year in the UK who have strokes, third to half will experience a so-called ‘minor stroke’. Although appearing benign these strokes put a person at increased risk of further strokes and survivors are usually considered ‘too good’ for referral onto community stroke services. When back at home the hidden effects of stroke like fatigue and changes in mood and cognition become apparent and impact return to work, relationships and everyday activities. Alongside this, managing the risk of recurrence, highest early after an initial stroke, is a priority. People with stroke report feeling abandoned after discharge with unmet information and support needs. To address this issue, we reviewed the literature, met with people with stroke and other stakeholders to develop an early, personalised follow-up programme of care for those who currently only receive routine medical follow-up appointments. The design of this complex intervention is informed by the NIHR/MRC framework for complex intervention development and the framework of action described by O’Cathain and colleagues. The intervention is underpinned by self-determination theory. We will be conducting a randomised, mixed methods, single-centre feasibility study to explore the acceptability and feasibility of the intervention. Sixty participants will be recruited from a Hyperacute Stroke Unit and Rapid Assessment Clinic and randomised to the intervention or control group. The intervention group will receive personalised follow-up appointments at two- and six-weeks post-discharge. All participants will have outcome measures taken at baseline and twelve-weeks post-stroke. Patient reported outcomes will be reviewed to assess their suitability for a later definitive trial. Qualitative interviews will be conducted to gain a deeper understanding of life after stroke from those who did and did not receive the intervention. Study findings will be used to further refine the intervention, methods and outcome measurements used. These refinements will inform a future multicentre randomised controlled trial. The term minor stroke refers to a stroke that has caused damage to a person’s brain that is visible on a brain scan, but the person has no obvious physical, thinking, or speaking problems. The stroke team think the person has made a good recovery and subtle stroke effects go unnoticed. The hospital stay is short and no onward therapy referrals are made. When back at home people realise they need more information about their stroke and how to reduce the risk of another stroke. As the person starts resuming their busy lives they notice the impact of fatigue, cognitive and mood changes. Getting stroke specific support at home is hard and people say they feel abandoned. Together with people who have experienced minor stroke we developed a follow-up programme of care to address this problem. A stroke therapist will conduct personalised follow-up appointments at two- and six-weeks after discharge. The appointments will focus on addressing unmet information needs and providing support and guidance to adjust to life after stroke. Referrals to community services will be made if needed. We will recruit participants from a hyperacute stroke unit and rapid assessment clinic. They will be randomised to receive the intervention or usual care. This feasibility study will tell us if people find the study processes, follow-up appointments and questionnaires acceptable. Both groups will complete questionnaires at baseline and 12-weeks and will be invited to take part in qualitative interviews. The learning from this feasibility study will let us know what changes and improvements need to be made before conducting a larger study to see if these personalised, follow-up appointments will improve the lives of people after a stroke. Minor stroke, complex intervention, feasibility study, secondary prevention, follow-up care, hidden impairments. Corresponding Author(s) Jennifer Crow ([email protected]) Grant information: This project is funded by the National Institute for Health and Care Research (NIHR) under its ‘ICA Programme Clinical Doctoral Research Fellowship’ (Grant Reference Number NIHR302124) (start date 01/09/2022) assigned to Jennifer Crow and by the HEE. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The Imperial College Healthcare NHS Trust is the main sponsor of this study. The sponsor reference number is 23CX8211. The Imperial College Healthcare NHS Trust holds standard NHS Hospital Indemnity and insurance cover with NHS Resolution for NHS Trusts in England, which apply to this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Crow J et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Crow J, Watt H, Wells M and Malhotra P. Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.13649.3) First published: 01 Aug 2024, 4:44 (https://doi.org/10.3310/nihropenres.13649.1) Latest published: 26 Feb 2025, 4:44 (https://doi.org/10.3310/nihropenres.13649.3) The Imperial College Healthcare NHS Trust is the main sponsor of this study. The sponsor reference number is 23CX8211. The Imperial College Healthcare NHS Trust holds standard NHS Hospital Indemnity and insurance cover with NHS Resolution for NHS Trusts in England, which apply to this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Following on from the review by Dr Merriman the manuscript has been improved in a number of ways. This included providing more information on what a complex intervention is and that the NIHR/MRC framework for complex intervention informed the development of this intervention. We have also provided more clarity on the definition we are using for TIA in this study. We have also provided more detail on what constitutes normal care for the reader. Finally, we have included keys for the abbreviations used in the tables. We thank Dr Merriman for her review. Following on from the review by Dr Merriman the manuscript has been improved in a number of ways. This included providing more information on what a complex intervention is and that the NIHR/MRC framework for complex intervention informed the development of this intervention. We have also provided more clarity on the definition we are using for TIA in this study. We have also provided more detail on what constitutes normal care for the reader. Finally, we have included keys for the abbreviations used in the tables. We thank Dr Merriman for her review. See the authors' detailed response to the review by Niamh A Merriman See the authors' detailed response to the review by Mathew Reeves The size of the problem Stroke is the leading cause of disability in the UK and there are 1.3 million people living with the after-effects of stroke1. Of the 150 000 strokes occurring per year, a third to a half of these are minor strokes2,3. The incidence and prevalence of stroke are increasing4 and the economic burden of stroke on society, health, social care, and the person and their family is significant5. A large population-based study in the United Kingdom showed a decline in stroke mortality rates6. However, there has been an increase in the event rates in the 35–54 age group6. The total annual societal cost of stroke in the UK is £26 billion; the largest portion of these costs, £20.6 billion, relates to the provision of ongoing care5. The importance of the problem Large-scale policy initiatives, such as the NHS Long Term Plan7 and the Stroke Plan for Europe8 have recognised the importance of improving stroke services. They are calling for a focus on improving life after stroke by improving how services work together and empowering people with stroke to manage their risk of further stroke and optimise their quality of life. Stroke shares many risk factors with cardiovascular disease (CVD), one of the largest contributors to health inequality9. One-fifth of the life expectancy gap between the most- and least-deprived communities is attributable to cardiovascular disease. Stroke is more common in people from South Asian and Black communities and they have the highest risk of CVD9. Stroke and cardiovascular disease can often be prevented by leading a healthy lifestyle; however, this requires communities that are supported, informed, and engaged. We also know that evidence-based treatments to reduce recurrence of stroke exist and yet evidence from a large South London Stroke Registry study has shown that the incidence of secondary stroke has not reduced since 200510. These data indicate that the implementation of secondary prevention programmes has not yet been optimised. The James Lind Alliance research priority setting partnership ensures that the voices of people with stroke carry equal weight to those of clinicians and researchers. Their stroke priority setting partnership report identified priority research areas that align with this research11: - What can stroke survivors do to reduce the risk of having another stroke? - What are the best interventions to promote recovery and prevent further stroke in people who have had strokes? - How can we recognise, assess, treat, and support people who experience hidden impairments (psychological problems, cognitive and communication changes, and fatigue) after a stroke? What is a minor stroke? There is no universally agreed definition for minor stroke12,13 and the terminology used, such as minor, mild, mini, and non-disabling, is confusing. In this feasibility study, we will use the tissue-based definition14 for minor stroke (a stroke visible on imaging). The definition we use for TIA is the presence of transient neurological symptoms which appear to have fully resolved within 24 hours and the absence of tissue damage on brain imaging. The National Institute for Health Stroke Scale (NIHSS) score is an impairment scale which is widely used in clinical practice and research to define minor, moderate or severe stroke (see Table 1)15. The most commonly used cut off points for minor stroke in research studies are NIHSS ≤ 3 or NIHSS ≤ 516. We will be using NIHSS ≤ 5 as our cut off point in this study. In our service the medical management of those with both minor stroke and TIA focuses on the identification and management of vascular risk factors. Both people with a diagnosis of TIA or minor stroke will have a therapy assessment on the HASU. Only those with a minor stroke are referred for a six-month stroke review. Community stroke therapy teams that subscribe to the time-based definition for TIA will usually not accept referrals for people with a diagnosis of TIA. Hyperacute treatments such as thrombolysis and thrombectomy improve survival post-stroke, and increasing numbers of people are discharged home with minimal physical disability. This scenario requires further attention from healthcare services and society. People with stroke say that a life saved is a life worth living, and services need to improve and change the focus from surviving to thriving17. What is a complex intervention? Many interventions used in healthcare are considered to be complex interventions, whereby the intervention consists of a number of different interacting components, each targeting different areas of behavioral change or aspects of health and wellbeing. Complex interventions allow a degree of flexibility as they are applied in different contexts or different systems to a wide range of individuals with varying levels of health literacy and from a diverse range of communities18. What happens in current practice? People with minor stroke typically have a very short length of stay in hospital or are increasingly being managed in outpatient clinics and emergency departments19. The clinical team focuses on ruling out obvious physical, cognitive, and communication difficulties. The assessment tools used are generally insufficiently sensitive to pick-up high-level impairments20,21. People consistently report that they receive insufficient personalised information prior to discharge22. The discharge summary is written with the general practitioner in mind and is often difficult for laypeople to understand. On discharge home, the person with stroke describes feeling abandoned and lost22,23. Given the lack of information provision and the inaccessible nature of discharge summaries to lay persons, it is not surprising that up to a third of people with stroke and TIA will have discontinued their medication within a year of discharge24. Current medical follow-up appointments are brief and focus specifically on medical issues and outstanding medical investigations. Ideally, these should occur 6 weeks post-discharge, but in practice, the wait for these appointments is often longer. These appointments rarely have multidisciplinary input; therefore, other issues relating to hidden effects, adjustment to life after stroke, and secondary prevention are seldom addressed. National Clinical Guidelines for Stroke (2023) recommend that all people after stroke should receive a holistic and structured 6-month review25. We conducted a scoping review to identify follow-up programmes, pathways, and services that have been developed for people after minor stroke26. Twenty-five studies were included in the analysis. Interventions often focused on education, secondary prevention, and exercise after stroke, whereas the management of hidden impairments and adjustment to life after stroke were less likely to be addressed. These complex interventions were often poorly described, and descriptions of family involvement, liaison between primary and secondary care, and underpinning psychological or behavioural theories were lacking. The review revealed that it is still unknown how best to organise services to offer personalised timely support and education to people in the community. There were two RCTs included in the scoping review, (STROKE-CARD27 and ‘Take Charge’28) that were able to demonstrate improvements in health-related quality of life at 12 months after the stroke. STROKE-CARD involved personalised, comprehensive multidisciplinary follow-up at 3 months post stroke and the Take Charge follow-up intervention was underpinned by self-determination theory and involved either one or two follow-up appointments. Take Charge’s person centred intervention focused on supporting a person to take charge of their recovery through supporting self-empowerment. The key elements from these two studies; multidisciplinary focus, personalised care and self-determination theory are included in the intervention described in this protocol. We believe that this may increase the likelihood of being able to show meaningful improvements in this diverse patient population. The objective of this feasibility study is to determine if an early, personalised, programme of care involving holistic follow-up of people with minor stroke discharged from the hyperacute stroke unit (HASU) and rapid assessment clinic (RAC) is acceptable and can feasibly be delivered within the NHS. It will address the following uncertainties: Recruitment rate (percentage of eligible people agreeing to take part). Treatment adherence rate (percentage of people attending both follow-up appointments and engaging in agreed actions). Participant retention rate (percentage of those in the intervention and control groups that complete the final outcome measurement). Acceptability and accessibility of outcome measures. Ability to gather self-report data to complete an economic evaluation. Acceptability and perceived benefit of the follow-up intervention. If the feasibility objectives meet the predefined progression decision criteria and the intervention and outcome measures are accessible and acceptable to those with minor stroke, then the next stage will be to deliver a definitive multicenter trial to determine the efficacy of this complex intervention. A patient and public involvement group with experience of minor stroke was instrumental in the study conception and design. Three online group meetings with six attendees and the lead investigator took place to plan and design the study. A further two face-to-face meetings with people from underserved communities who did not wish to attend online group meetings were also held. Their input highlighted the challenges of online meetings, reading study documentation, and completing outcome measures on a mobile phone for those who do not have access to laptops or desktops. In the online and face-to-face meetings, the importance of the research idea was explored, the research question was agreed upon, the intervention was developed and refined, and this included participants’ input shaping the frequency and content of the follow-up appointments. An underpinning theory was presented, and its relevance and understandability were critiqued by the group. Outcome measures originally considered were excluded based on group feedback, and the final measures were agreed upon. To improve the inclusivity of this research, perspectives and feedback from a diverse range of people were obtained. This included presenting the planned research to a group of ethnic minority women from an underserved community. Through this group, an improved understanding of the barriers and concerns of this community regarding follow-up care was developed, and recruitment processes were adapted accordingly. Our team was exposed to different health belief systems and attitudes towards disease and recovery. In addition, a group member reviewed the information sheet and the consent form. Based on her feedback, an accessible supplementary information sheet was developed, and improvements were made in the consent form. Engagement with acute and community-based stroke clinicians in localities beyond our own confirmed that the lack of structured follow-up care for people after minor stroke also exists in other services. We learned about clinical services that are attempting to deliver different models of follow-up care to complement the narrow focus of stroke medical follow-up appointments. Addressing secondary prevention, adjustment to life after stroke, and assessment of ongoing therapy needs requires additional multidisciplinary staff in the clinic. Services described difficulties in obtaining substantive funding to enable stroke follow-up clinics to provide more holistic and personalised care. We are also engaged in an international collaboration with other researchers in this field. We are conducting a systematic review to collate the latest evidence on the lasting impairments experienced after minor stroke and TIA29. The current trial is a two-armed, parallel group, randomised, single-center, feasibility study with embedded qualitative interviews. Participants and the outcome assessor, a specialist occupational therapist (OT), will not be blinded to the intervention. The study flowchart is shown in the Consort Diagram Figure 1. This protocol has been reported in accordance with SPIRIT guidelines30. The template for the intervention description and replication (TIDieR) checklist was used to report the intervention details31. These documents can be found in the Open Science Framework Repository. https://osf.io/gnw57/ Recruitment: Participants with a NIHSS score of ≤5 at 2 hours post admission and meeting the other inclusion criteria will be recruited from the HASU and RAC. People attending the RAC are referred to the clinic via their GP or may have been seen in the emergency department and discharged home but with follow-up investigations to be completed in the clinic. Both the HASU and RAC are located in a high-density, ethnically diverse, urban environment. Outcome measurement: Baseline measures for both groups will be conducted by the OT in the hospital where possible, but if the person is discharged quickly or seen in the RAC, then they will be conducted at the persons home or in the clinic. The final outcome measurement location will be agreed upon by the participant and could be in their home or in the hospital. Intervention: Participants will determine their preferred location for follow-up appointments. They will be offered in-person appointments in the outpatient clinic at the hospital, appointments over the telephone or video call, or in their home or neutral venue in the community. This personalised approach is based on PPI input into the study design and aims to increase the inclusivity of the study. Online appointments introduce digital exclusion and favour younger participants. On the other hand, having to travel to the hospital may be a deterrent for older participants or those who are back at work. ClinicalTrials.gov - NCT05897905 (22/05/2023) Accessed at: https://classic.clinicaltrials.gov/ct2/show/NCT05897905 Protocol V4 (31/03/2023), approval date 21/07/2023. Substantial amendment - SA01 – Protocol V5 (26.10.2023), approval date 06/02/2024. Inclusion criteria Adult ≥18 Clinical or radiological diagnosis of minor stroke from a stroke consultant. Admitted to HASU or seen in RAC. Pre-admission modified Rankin Score (mRS) of 0–3 (see table below), with no formal package of care prior to stroke. Table 1. Modified Rankin Scale scores32 NIHSS ≤ 5 at 2 hours post admission. Table 2. Stroke Severity – National Institute of Health Stroke Scale Score Within one week of receiving stroke diagnosis. Discharge mRS of 0–3. No onward referral to community therapy team or for package of care. Has capacity to consent. | NIHSS Score | Stroke Severity | |---|---| | 0 | No Stroke symptoms | | 0–4 | Minor Stroke | | 5–15 | Moderate Stroke | | 16–20 | Moderate to Severe Stroke | | 21–42 | Severe stroke | Family member inclusion criteria for qualitative interview (SA-01) Family members or partners who participated in and/or supported the researcher with the recruitment process, intervention delivery, and outcome measurement. Exclusion criteria Any serious comorbidities that would impact a person's ability to participate in follow-up appointments and outcome measurement. Insufficient English to engage in intervention and outcome measures, and no family or friends to support with this. Not resident in England. Pregnant women. Enrolled in another interventional trial that does not allow co-enrolment or observational studies where the burden of assessment may be too high. The researcher will review the electronic records of all new admissions to the HASU. If the patient meets the study criteria, eligibility is confirmed by the assessing team. This process is followed for weekend admissions. If the researcher is unable to attend the ward in person prior to discharge, then consent for contacting the patient post-discharge will be obtained and documented. In the RAC, potential study participants will be identified by stroke clinical nurse specialists, and consent will be obtained for the researcher to contact the person following discharge. Consent for participation in the study will be completed by the researcher either on the ward or in the clinic or at the participant’s home. Data will be collected to capture the baseline and clinical characteristics of those approached for study involvement as well as their ethnicity, and level of education (Table 3). Strategies to promote recruitment: Therapy staff within the stroke service are rotational; therefore, regular study updates will be given to the therapy team by attending their fortnightly team meetings. A template of what to write in the patient record when approaching a potential study participant will be provided, and the study inclusion and exclusion criteria will be clearly displayed on the therapy information board on the ward. The recruitment target is five participants per month from the HASU. This target is based on pilot data; people with minor stroke were recruited from the HASU over a three-month period to a two-week follow-up study involving online cognitive testing33. No preliminary data gathering was conducted at the RAC, but time was spent in the clinic to understand what a clinic appointment involves for the patient. A smaller proportion of people who attend this clinic will receive a diagnosis of stroke; therefore, the recruitment target is set at two participants per month. Participants will be randomised to the intervention or control group by simple randomisation using a 1:1 allocation ratio and opaque sealed envelopes to ensure allocation concealment. Randomisation will be stratified by recruitment location to ensure treatment assignment is balanced between the two groups within each location. Progression criteria related to feasibility outcomes were identified. We plan to recruit 60 participants (30 in the control group and 30 in the intervention group) in line with sample sizes for similar feasibility studies34. Feasibility studies need to be much smaller than full-efficacy trials to be considered worthwhile. The feasibility outcome “participant retention” is the percentage of 60 participants who complete outcome measurements at 12 weeks. Using a binomial probability confidence interval (CI) calculator with a sample size of 60, the 95% CI on proportions will have widths no greater than 37% (based on the 50% proportion having a 95% CI from 37% to 63%. Proportions further from 50% would have narrower CIs; for example, 90% has a 95% CI from 79–96%, so this CI has a width of 17%. Free Binomial Probability Confidence Interval Calculator - Free Statistics Calculators (danielsoper.com) The width of these CIs provides a reasonable balance between the cost and practicality of patient recruitment. The feasibility outcome “recruitment uptake” would have narrower CIs (since 60 is the numerator with a larger denominator). There is no relevant power calculation because the main outcomes are proportions rather than anything that can be assessed using hypothesis testing. The progression criteria targets are described in Table 4. They provide a guide through the use of a predefined traffic light system of red (stop), amber (amend, modifications needed), and green (proceed), as to whether the study could proceed to a future definitive trial. The targets may seem ambitious, but due to the limited number of appointments and personalised nature of the intervention, where participants do not need to attend appointments at the hospital, we believe these are achievable. We have carried out extensive work with diverse community groups that has improved our understanding of culturally appropriate ways to approach patients from different communities. Further, this is also a single-centre study, with the lead researcher having established working relationships with the other members of the stroke team. It will be made clear to all potential participants through the consent form and discussions that they are free to withdraw from study participation at any point, and that they are not required to provide a reason for this. The intervention is a personalised, holistic follow-up programme of care. It has been developed for a diverse population with differing stroke aetiologies and social contexts and for this reason was guided by the NIHR/MRC framework for complex interventions18 alongside the framework of actions developed by O’Cathain and colleagues35. The behavioural theory chosen to underpin this intervention is self-determination theory (SDT). This theory aims to increase autonomous motivation, which has been shown to be associated with improvements in initiating and sustaining healthy behaviours36–38. The techniques described by SDT aim to support a person’s three basic psychological needs for competence, autonomy, and relatedness39. It highlights the importance of considering a person’s biological, social, and cultural contexts, which is critical given the diversity of the stroke population. The follow-up appointments will address knowledge gaps, provide support, education, guidance, signposting, and onward referrals as needed. A detailed description as per the TIDieR guidelines for the intervention and control groups is provided in the Open Science Framework (OSF) data repository. https://osf.io/gnw57/ The hypothesized mechanisms for action of the intervention are underpinned by self-determination theory and are: 1) Enhanced, personalised communication – this requires listening to and understanding the participants priorities and needs. It requires an understanding of a person’s health literacy and education level. Communication is personalised and adjusted according to the participants needs. 2) Partnership working – this approach changes the power dynamic in healthcare interactions and moves away from traditional hierarchical, paternalistic approaches and facilitates the pursuit of personalised goals. It involves linking the participant in with or referring them on to other support services in the community. This approach helps to address adjustment to life after stroke and can mitigate against feelings of isolation and abandonment. It aims to support a sense of belonging, feeling cared for and connected with others. 3) Enablement – by focusing on communication and partnership working a participant is supported to have freedom of choice to engage in actions that are congruent with their values and priorities. They are given the tools and knowledge to influence the outcomes that are important to them. This supports intrinsic motivation to initiate and sustain behaviour that supports health and wellbeing. A training manual for those delivering the intervention has been developed and can be found in the OSF data repository in the intervention delivery folder, accessed here: https://osf.io/gnw57/ The manual describes the principles of SDT and how the techniques can be employed during follow-up appointments. It also describes the key knowledge and skills that are required by the person delivering the intervention and outlines the domains of functioning to be covered in the assessment conducted at the follow-up appointments. Topic areas for discussion in each follow-up appointment are listed, and guidance is provided when onward referrals are needed. Links to relevant informational resources that the participant may require are included in this manual, as well as what to consider if referring to local community stroke services. An intervention delivery checklist has been created to check off all the actions that need to be taken from recruitment through to outcome measurement at 12 weeks. This is also available in the extended data. The participants GP will be informed of their involvement in the study and which group they have been randomised to. A brief description of the purpose of the study and what it involves, as well as the researcher’s contact details will be included in the letter sent to the GP. For this feasibility study, the lead researcher, who is an experienced stroke occupational therapist, will deliver the intervention. The intention, however, is that this intervention could be delivered by other allied health professionals (AHPs) or nurses with experience working with the stroke population. Therefore, the training manual is designed to address the training needs of both nurses and AHPs. This will be reviewed by nurses and AHPs to obtain feedback on the content, layout, and general utility in supporting delivery of the intervention. The mode of delivery of the intervention will focus on inclusivity. To ensure the delivery of a personalised intervention, follow-up appointments will be offered face-to-face in person at the hospital, participant’s home, or a neutral venue in the community, or as a telephone or video call appointment. Participants will have the option of completing their twelve-week outcome measurement in person or alternatively electronic versions of the outcome measures will be sent to participants for their completion. The preferred modality will be noted and will inform a future definitive trial. Where signposting to online information resources or digital Apps is indicated this will form part of the intervention. This will however only be utilized with those that are familiar with and have easy access to these technologies. The intervention is composed of two follow-up appointments and telephone access to the researcher to address questions that may arise between appointments. The researcher has direct access to the clinical team and stroke clinical specialist nurses if medical concerns are raised. This may help to address feelings of abandonment that are frequently described in the literature. Currently it is very difficult to have ad hoc contact with the stroke clinical team after discharge. Participants in this group will receive referral to the Stroke Association Connect Service and six-month stroke review referrals as part of standard care. The formal follow-up appointments will occur at 2 and 6 weeks after recruitment and will last from 30 to 60 min, depending on the identified needs. Appointment 1 (two weeks after discharge): - Understand the participant’s priorities and expectations for the appointment. - Review functional and psychosocial status. This will provide information on the early impact of stroke, determine what support the participant has in the community, and provide insights into how they are adjusting to their new diagnosis. - Address the participant’s knowledge gaps regarding stroke, medication, and secondary prevention. - Agree onward referrals if indicated and action plan for participant and clinician. - Written summary sent to GP with topics discussed and action plan agreed. - Summary of discussion points provided to participant when required or requested. - Complete an early post-stroke quality of life measure (patient-reported outcome measurement information system, PROMIS10) Appointment 2 (six weeks after discharge): - Understand the participant’s priorities and expectations for appointment. - Review actions from first appointment. - Address any new or persistent information gaps. - Review functional and psychosocial status, with a focus on potential hidden impairments that may impact return to work, activities of daily living, relationships, or general well-being. - Agree onward referrals and action plan. - Summary of discussion points provided to participant when required or requested. - Written summary and plan to be sent to GP with topics discussed and action plan agreed. Examples of onward community-based referrals that may be needed include referral to the community stroke therapy team. This may be highlighted when the person is back at home and engaging in their everyday activities and they then become aware of higher-level difficulties that were not detected initially. The hidden impacts of stroke such as fatigue and mood issues are also more likely to become apparent after a period of time at home. The UK and Ireland National Clinical Guidelines for Stroke (2023) now support the need for referral for ongoing rehabilitation at any time point after a stroke if new goals are identified. Other referrals to voluntary sector organisations for information, peer support or exercise groups can also be made if indicated. Tailoring The content and direction the appointment takes is guided by the manual, but will be tailored by the participant’s own priorities, knowledge gaps, and functional difficulties experienced since their stroke. Information delivery will be tailored to general literacy and health literacy. The participants’ family members or partners will be able to join follow-up appointments if they wish. Baseline and outcome measurement Baseline measures for both groups will be conducted by the OT in the hospital where possible, but if the person is discharged quickly or seen in the RAC, then they will be conducted at the persons home or in the clinic. Baseline assessment will be conducted within one week of the stroke. The location of the final outcome measurement will be agreed upon by the participant and could be in their home or in the hospital. Measurement will be taken by the OT delivering the intervention. Participants will be invited to participate in qualitative interviews after the 12-week outcome measurement period. Control group The participants in the control group will receive standard care. This involves the provision of a printed information sheet on therapy services that exist in their locality and referral to the Stroke Association Connect service, which makes telephone contact with the person after discharge. A six-month stroke review referral is also sent, but currently, this is not consistently provided across all localities. In addition to standard care, those in the control group will be provided with a mobile number and email address for the lead researcher to enable easy contact during the 12-week duration of the study if questions arise relating to their stroke or its effects. If referrals onto community stroke therapy services are indicated at the 12-week outcome measurement appointment then they will be made at that time. The time points at which these measurements and secondary feasibility outcomes are taken are presented in the schedule of events table (Table 5). Table 5 key: HCCQ-Healthcare Climate Questionnaire, PROMIS-10-Patient-reported outcome measurement information system, PEI-Patient enablement instrument, SA01- Substantial amendment 1, mRS-modified Rankin scale, PHQ2-Patient health questionnaire 2, PHQ9-Patient health questionnaire 9, GAD7-Generalised anxiety disorder 1. Recruitment rate (Time point 0 = T0): Proportion of participants randomised relative to the total number meeting the inclusion criteria. Reasons for declining participation will be recorded. The ability to gather baseline and EDI data will be noted as will acceptability of randomisation. 2. Treatment adherence rate (Time point 3 = T3): Proportion of participants in the intervention group who attend both follow-up appointments. When people drop out reasons for this will be obtained. 3. Participant retention rate (T4) - Proportion of all participants that complete the follow-up questionnaires. 1. To complete patient reported outcome measures and review their acceptability, accessibility, and responsiveness to inform the primary outcome for a main trial. i. PROMIS10 - Patient-reported outcome measurement information system. This quality-of-life measure was chosen because it has been found to be more sensitive in people who have mild strokes40,41 (T1 and T4). ii. HCCQ - Health Care Climate Questionnaire Short Form – This is a measure of self-determination, particularly autonomy support in health care appointments42 (T0 and T4). iii. PHQ9 – Patient Health Questionnaire – measure of depression41,43 (T4). iv. GAD7 – Generalised Anxiety Disorder – measure of anxiety44 (T4). v. PEI - Patient Enablement Instrument – measures whether an appointment with a healthcare practitioner impacts a person’s ability to manage their illness45 (T4). 2. To assess stroke knowledge, questions used relate to information that should be provided to patients in their personal stroke record available at: https://www.stroke.org.uk/sites/default/files/professionals/jn_2223-055_-_personal_stroke_record.pdf This document (patient passport) was developed by the Stroke Association in collaboration with stroke survivors, their families, clinicians, and NHS England. The stroke knowledge questions that will be asked are: i. What type of stroke did you have? ii. What treatment have you had for your stroke? iii. Where in your brain did the stroke happen? iv. How has your stroke affected you? v. How can you reduce your risk of another stroke? vi. What new medication are you on? vii. What are the medications for? viii. What should you do if you experience symptoms of another stroke? 3. To complete the cognitive screening assessment, the Montreal Cognitive Assessment46,47 (MoCA) will be conducted in person where possible otherwise over the telephone or video call (T-MOCA48) (T0 and T12). 4. To determine the feasibility of gathering self-reported health and social care usage data (attendance at GP and A&E for stroke-related concerns and new packages of care). 5. To complete qualitative interviews (T5). 6. To determine treatment costs based on appointment, administration and travel time. 7. To note which mode of follow-up is most preferred by participants and whether outcome measures can be effectively completed over the telephone. 8. To obtain feedback on the training manual and intervention delivery checklist from therapy and nursing staff. Participants in the control and intervention groups will be invited to participate in qualitative, semi-structured interviews. The focus of this will be to explore and understand the experience of receiving a diagnosis of stroke and life after stroke for those who received the intervention and those who did not. We will also seek to understand whether the intervention delivered was acceptable and how it could be improved. We will aim to conduct interviews with 15 to 20 participants. Purposive sampling will be used to ensure that the views of participants from both groups and with a variety of demographic characteristics and experiences after their stroke are obtained. The interviews will be recorded and transcribed verbatim. The interviews will be face-to-face, either on video calls, in the clinic, or at the person’s home. A topic guide will be used, and the interviewer will maintain a field diary to capture reflections and thoughts. We will review the quantitative measures alongside subjective reports from the participants to evaluate whether there is alignment of the qualitative perspectives and quantitative results. The planned purposive sampling strategy will enable the researcher to interview those who seemed to cope well with the transition back to their lives as well as those that appear to be having more adjustment difficulties. This will capture a diversity of experiences and perspectives. We will explore whether the themes that arise from the qualitative data are captured in the quantitative measures used. Key concepts and themes that are prominent in the qualitative data will help the researcher to understand what matters to the participants. This also creates an opportunity for participants to introduce topics that may not be reflected in the outcome measures used in the feasibility study. Through these processes we aim to increase the likelihood of identifying a primary outcome for a subsequent definitive trial that is sufficiently nuanced to capture efficacy in a socio-culturally diverse population. Alongside the study participants, family members that have supported the participant in the research study will be invited to participate in a separate interview. We will aim to conduct at least five interviews with family members. The data analysis approach will be thematic using the six phases described by Braun and Clarke49. This involves familiarising oneself with the interview transcripts to obtain initial ideas and thoughts and then producing initial codes from the data. Following this, the researcher looks more broadly at the codes to find themes in the data, comparing and contrasting findings across interview transcripts to consider any commonalities, differences, patterns, expected, and unexpected themes. These will be reviewed, using all supporting data to check for credibility and coherence, before refining the final themes and confirming how they interact and relate to each other prior to writing up the findings49. Data will be analysed inductively, but emerging themes will also be considered in relation to Self-Determination Theory to assess the coherence of findings with the theory underpinning the intervention. Computer-assisted qualitative data analysis software (NVivo 14) will be used to support the analysis. Techniques to ensure rigour, such as reflexivity, will be used and reported to understand the researcher’s contextual, personal, and interpersonal influences on the research process50. Peer reviewing of data with a clinical and academic colleague will be conducted, and where perspectives expressed are not clear during data analysis, these will be checked with the participants. Observations and comments noted during the follow-up appointments and the final outcome measure appointment will be referred to during data analysis to add further contextual information to the analysis. All participants will be assigned a participant ID at the point of consent. Personal data and linking codes will be stored in separate locations using encrypted digital files and password-protected folders. The Case Report Forms (CRF) and questionnaires will only contain participant ID. Paper consent forms, pseudonymised CRFs, and questionnaires will be stored in secure NHS offices in locked cabinets. Scanned copies of the paper consent forms and questionnaires will be stored on secure NHS servers. All data will be collected in accordance with the Data Protection Act 2018 and in line with general data protection regulations (GDPR). Consent will be sought and in place for monitors and auditors from regulatory authorities to have access to identifiable information where relevant. Encrypted NHS devices will be used to record the interviews. Transcription of qualitative interviews will involve the transfer of voice recordings to a transcription service that has a data-sharing agreement with the sponsor. The participant ID will be used to label the audio files. All study documentation will be archived in accordance with the sponsor policy. Data will be destroyed after 5 years. The data obtained will be reported descriptively, and analysis will be conducted using Statistical Package for Social Sciences (SPSS) version 29. The primary analysis will focus on the feasibility outcomes and be presented as proportions with confidence intervals. The monthly recruitment rates will also be noted. Retention data will be noted by group (control and intervention) as well as overall and presented as proportions. Baseline demographics and clinically relevant data will be reported to enable the understanding of participant characteristics and to enable other services to draw comparisons with their patient demographics. The responsiveness of the outcome measures to change will be reviewed using confidence intervals for changes from baseline in each group and for between-group comparisons of changes. The numerical results and perceived relevance of the outcome measures used in this feasibility study will be considered. It should be noted that for the current feasibility study the outcome assessor is not blinded, and this has the potential to introduce bias in the assessment. The plan for a future definitive trial would involve a blinded outcome assessor. The quantitative results will be considered alongside the qualitative findings to illuminate any individual or contextual insights from interviews that help to explain quantitative data. All of these will inform the choice of the primary outcome for a subsequent definitive trial evaluating efficacy. The economic evaluation and feasibility of self-reported healthcare use will be explored. We will consider the treatment, administration, and clinician travel time to estimate the cost of delivering the intervention. Healthcare usage (GP and A&E attendance for stroke-related concerns) will be obtained from both groups. Self-report data will also capture those that are back at work in their previous capacity, as well as those that have not returned to work or are working in a part-time capacity. We will also capture data where packages of care have been started to support someone at home following their stroke. The study is sponsored by Imperial College Healthcare NHS Trust (ICHNT) and has been reviewed and received approval by the Imperial College London and ICHNT Joint Research Office. The principal investigator will ensure day-to-day management of the trial and will be overseen by the Chief Investigator. The study management group will have an independent chair and two lay members. It will monitor the progress of the trial, recruitment rate, adherence to the protocol, and completion of outcome measures to ensure that the study is progressing as planned. An independent data-monitoring committee is not indicated. The study may be subject to audit by Imperial College Healthcare NHS Trust under their remit as sponsor and other regulatory bodies to ensure adherence to Good Clinical Practice (GCP) and the UK Policy Framework for Health and Social Care Research. Dissemination will be targeted and tailored to different audiences. The findings of this feasibility study will be disseminated in a plain English summary to study participants at two time points: at the end of recruitment and after data analysis. Dissemination to other key stakeholders will occur via team updates and presentations of findings in local, regional, and national stroke meetings. Another avenue for dissemination will be through professional networks and social media platforms. The findings of the feasibility study and qualitative interviews will be shared at relevant conferences and in open-access peer-reviewed journals to gain the maximum impact. The study received ethical approval from the Hampstead Research Ethics Committee (REC) and the HRA and Health and Care Research Wales on 24/05/2023. REC reference number: 23/LO/0424. The IRAS Project ID is 321584. Documas No: 23CX8211. The NHS confirmation of capacity and capability was received on 21/07/2023. A substantial request for protocol amendment was submitted on 01/11/2023. This involved adding the Patient Enablement Index to the outcome measures at 12 weeks and including caregivers or family members in the qualitative interviews. If a family member is involved in the recruitment process, baseline measurement, and follow-up appointments, they will be invited to participate in a qualitative interview at the end of the study. The researcher will go through the participant’s information sheet and address any questions that arise. Time will be allowed if the potential participant wants to talk to the family or needs more time to consider their involvement in the study. Translators will not be used, but for those with limited English proficiency, family members who speak sufficient English will be used to support the consent process. Feedback from an underserved community highlighted the fear and distrust that existed in these communities when presented with complex participant information sheets. An accessible supplementary information sheet will be used alongside the full participant information sheet and consent form to improve the accessibility of the study information. The consent form, accessible supplementary material, and participant information sheet can be found in the Open Science Framework data repository https://osf.io/gnw57/ The reporting guidelines used in this study are the SPIRIT guidelines, and TIDieR checklist. These can be found in the Open Science Framework Data Repository51 https://osf.io/gnw57/ The following extended data are also available in the Open Science Framework data repository: consent form (participant and family member), participant information sheet (for family and participant), accessible information sheet, study protocol, training manual and the assessment and intervention delivery checklist. Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Our patient and public involvement (PPI) groups have contributed to the inception of this research idea, research question, intervention design and content, review of underpinning theory, and outcome measure selection. 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Crow J, Wells M, Malhotra P: Improving follow-up care after minor stroke using early personalised care. 2024. http://www.doi.org/10.17605/OSF.IO/GNW57 Author details Author details 1 Department of Occupational Therapy and Physiotherapy, Imperial College Healthcare NHS Trust, London, UK 2 Department of Brain Sciences, Imperial College London, London, England, UK 3 Department of Primary Care and Public Health, Imperial College London, London, England, UK 4 Department of Surgery and Cancer, Imperial College London, London, England, UK 5 Nursing Directorate, Imperial College Healthcare NHS Trust, London, UK 2 Department of Brain Sciences, Imperial College London, London, England, UK 3 Department of Primary Care and Public Health, Imperial College London, London, England, UK 4 Department of Surgery and Cancer, Imperial College London, London, England, UK 5 Nursing Directorate, Imperial College Healthcare NHS Trust, London, UK Jennifer Crow Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Hilary Watt Roles: Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Roles: Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Mary Wells Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Paresh Malhotra Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This project is funded by the National Institute for Health and Care Research (NIHR) under its ‘ICA Programme Clinical Doctoral Research Fellowship’ (Grant Reference Number NIHR302124) (start date 01/09/2022) assigned to Jennifer Crow and by the HEE. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The Imperial College Healthcare NHS Trust is the main sponsor of this study. The sponsor reference number is 23CX8211. The Imperial College Healthcare NHS Trust holds standard NHS Hospital Indemnity and insurance cover with NHS Resolution for NHS Trusts in England, which apply to this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The Imperial College Healthcare NHS Trust is the main sponsor of this study. The sponsor reference number is 23CX8211. The Imperial College Healthcare NHS Trust holds standard NHS Hospital Indemnity and insurance cover with NHS Resolution for NHS Trusts in England, which apply to this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (3) Copyright © 2025 Crow J et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. metrics VIEWS $counts.viewCount downloads Citations CITE how to cite this article Crow J, Watt H, Wells M and Malhotra P. Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.13649.3) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. track receive updates on this article Track an article to receive email alerts on any updates to this article. Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions Version 3 VERSION 3 PUBLISHED 26 Feb 2025 Revised Views 0 How to cite this report: Merriman NA. Reviewer Report For: Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.15143.r34814) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-44/v3#referee-response-34814 https://openresearch.nihr.ac.uk/articles/4-44/v3#referee-response-34814 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 27 Feb 2025 Approved VIEWS 0 Thank you to the authors for considering my comments and revising the ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close Thank you to the authors for considering my comments and revising the paper. I have no further comments and recommend that the paper is indexed. Competing Interests: No competing interests were disclosed. Reviewer Expertise: Complex intervention development; evidence synthesis; cognition; ageing; post-stroke cognitive rehabilitation CITE HOW TO CITE THIS REPORT Merriman NA. Reviewer Report For: Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.15143.r34814) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-44/v3#referee-response-34814 https://openresearch.nihr.ac.uk/articles/4-44/v3#referee-response-34814 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Version 2 VERSION 2 PUBLISHED 25 Nov 2024 Revised Views 0 How to cite this report: Merriman NA. Reviewer Report For: Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.15013.r34334) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-44/v2#referee-response-34334 https://openresearch.nihr.ac.uk/articles/4-44/v2#referee-response-34334 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 10 Feb 2025 Approved with Reservations VIEWS 0 The authors present a well written and detailed protocol for a randomised, mixed methods, feasibility study of a complex intervention to improve follow-up care for people with minor stroke. This a very important topic and I look forward to seeing ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close The authors present a well written and detailed protocol for a randomised, mixed methods, feasibility study of a complex intervention to improve follow-up care for people with minor stroke. This a very important topic and I look forward to seeing the results of feasibility study. I would recommend some minor amendments to improve clarity:

I would be explicit that the NIHR/MRC framework for complex intervention development and the framework of actions informed the design of the intervention.

Under the heading ‘what is a minor stroke?’, I would recommend defining transient ischaemic attack at this stage. It would also be useful to the reader to know what similarities and differences in treatment there are for minor stroke or TIA and stroke as well. In this section, the authors state they will recruit patients with an NIHSS score of ≤5 at 24 hours post-admission, however the eligibility criteria specify an NIHSS score of ≤5 at 2 hours post-post. It would be good to clarify the time point and move this information to the methods section. Similarly, the authors discuss their aim mid-introduction and that is best placed with the study objectives section. I think it would be worthwhile to include a definition of complex interventions. I think some more information on what constitutes usual care would be informative to the reader. The authors mention the 6-week review, but it would be good to include the National Clinical Guidelines for Stroke recommendation of 6-month stroke review as well since this is the usual care timeframe mentioned in the methods section.

It would be useful to the reader to include a table outlining what the different NIHSS scores mean, similar to the table describing the MRS. Also, a key is needed for the abbreviations in each of the tables. General comments I wish the authors the best of luck with this very worthwhile project. I would recommend some minor amendments to improve clarity:

I would be explicit that the NIHR/MRC framework for complex intervention development and the framework of actions informed the design of the intervention.

Under the heading ‘what is a minor stroke?’, I would recommend defining transient ischaemic attack at this stage. It would also be useful to the reader to know what similarities and differences in treatment there are for minor stroke or TIA and stroke as well. In this section, the authors state they will recruit patients with an NIHSS score of ≤5 at 24 hours post-admission, however the eligibility criteria specify an NIHSS score of ≤5 at 2 hours post-post. It would be good to clarify the time point and move this information to the methods section. Similarly, the authors discuss their aim mid-introduction and that is best placed with the study objectives section. I think it would be worthwhile to include a definition of complex interventions. I think some more information on what constitutes usual care would be informative to the reader. The authors mention the 6-week review, but it would be good to include the National Clinical Guidelines for Stroke recommendation of 6-month stroke review as well since this is the usual care timeframe mentioned in the methods section.

It would be useful to the reader to include a table outlining what the different NIHSS scores mean, similar to the table describing the MRS. Also, a key is needed for the abbreviations in each of the tables. General comments I wish the authors the best of luck with this very worthwhile project. - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Yes - Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Complex intervention development; evidence synthesis; cognition; ageing; post-stroke cognitive rehabilitation CITE HOW TO CITE THIS REPORT Merriman NA. Reviewer Report For: Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.15013.r34334) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-44/v2#referee-response-34334 https://openresearch.nihr.ac.uk/articles/4-44/v2#referee-response-34334 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. - Author Response 26 Feb 2025Jennifer Crow, Department of Occupational Therapy and Physiotherapy, Imperial College Healthcare NHS Trust, London, UK26 Feb 2025Author ResponseDear Dr Merriman Thank you for the time you have taken to review this paper and for your helpful comments. Please find our response below to all the points you ... Continue reading Dear Dr Merriman Thank you for the time you have taken to review this paper and for your helpful comments. Please find our response below to all the points you have raised. We present each suggestion you have made or question you have asked and then the relevant current text in the manuscript. We then present the changes we have made based on your suggestions. Text added to the original manuscript is underlined. 1.Your suggestion:

I would be explicit that the NIHR/MRC framework for complex intervention development and the framework of actions informed the design of the intervention. Current text: This complex intervention is underpinned by self-determination theory, which forms a framework for delivery of the intervention. Changes made based on your suggestion: The design of this complex intervention is informed by the NIHR/MRC framework for complex intervention development and the framework of action described by Alicia O’Cathain and colleagues. The intervention is underpinned by self-determination theory, which forms a framework for delivery of the intervention. 2. Your suggestion:

Under the heading ‘what is a minor stroke?’, I would recommend defining transient ischaemic attack at this stage. It would also be useful to the reader to know what similarities and differences in treatment there are for minor stroke or TIA and stroke as well. Current text: In this feasibility study, we will use the tissue-based definition for minor stroke (a stroke visible on imaging), and in terms of impairment scores we will recruit patients with a National Institute of Health Stroke Scale (NIHSS) score ≤ five at 24 hours post admission. Changes made based on your suggestions: In this feasibility study, we will use the tissue-based definition for minor stroke (a stroke visible on brain imaging). The definition we use for TIA is the presence of transient neurological symptoms which appear to have fully resolved within 24 hours and the absence of tissue damage on brain imaging. The National Institute for Health Stroke Scale (NIHSS) score is an impairment scale which is widely used in clinical practice and research to define minor, moderate or severe stroke (see Table 1)(1). The most commonly used cut off points for minor stroke in research studies are NIHSS ≤ 3 or NIHSS ≤ 5(2).We will be using NIHSS ≤ 5 as our cut off point in this study. In our service the medical management of those with both minor stroke and TIA focuses on the identification and management of vascular risk factors. Both people with a diagnosis of TIA or minor stroke will have a therapy assessment on the HASU. Only those with a minor stroke are referred for a six-month stroke review. Community stroke therapy teams that subscribe to the time-based definition for TIA will usually not accept referrals for people with a diagnosis of TIA. Ref added: 1. Schwartz JK, Capo-Lugo CE, Akinwuntan AE, Roberts P, Krishnan S, Belagaje SR, et al. Classification of Mild Stroke: A Mapping Review. PM R. 2019;11(9):996-1003. Ref added: 2. Leng X, Wang D. Editorial: minor stroke is not minor. Stroke Vasc Neurol. 2023;8(3):175-7. 3. Your question:

In this section, the authors state they will recruit patients with an NIHSS score of ≤5 at 24 hours post-admission, however the eligibility criteria specify an NIHSS score of ≤5 at 2 hours post-post. It would be good to clarify the time point and move this information to the methods section. Our response: Thank you for highlighting this inconsistency, we have now corrected this. The correct time point is NIHSS score of ≤5 at 2 hours post admission. Changes made based on your suggestion: We have moved this to:

Setting Recruitment: Participants with NIHSS score of ≤5 at 2 hours post admission and meeting the other inclusion criteria will be recruited from the HASU and RAC. 4. Your suggestion:

The authors discuss their aim mid-introduction and that is best placed with the study objectives section. Our response: We agree that this should be in the study objectives section and so this has been removed from the introduction and placed in the study objectives section. 5. Your suggestion:

I think it would be worthwhile to include a definition of complex interventions. Our response: We agree that including a definition of complex interventions will enhance the manuscript. Current text: nothing explained about what a complex intervention is in the original text. Changes made based on your suggestion: We have added a short paragraph in the introduction section between the paragraph ‘What is a minor stroke?’ and the paragraph ‘What happens in current practice?’ which we have headed with ‘What is a complex intervention?’ What is a complex intervention? Many interventions used in healthcare are considered to be complex interventions, whereby the intervention consists of a number of different interacting components, each targeting different areas of behavioural change or aspects of health and wellbeing. Complex interventions allow a degree of flexibility as they are applied in different contexts or different systems to a wide range of individuals with varying levels of health literacy and from a diverse range of communities (3). Ref added: 3. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374: n2061 6. Your suggestion:

I think some more information on what constitutes usual care would be informative to the reader. The authors mention the 6-week review, but it would be good to include the National Clinical Guidelines for Stroke recommendation of 6-month stroke review as well since this is the usual care timeframe mentioned in the methods section. Our response: We have added information on the 6-month stroke review which is offered as part of usual care in the methods section. Current text: Current medical follow-up appointments are brief and focus specifically on medical issues and outstanding medical investigations. Ideally, these should occur 6 weeks post-discharge, but in practice, the wait for these appointments is often longer. These appointments rarely have multidisciplinary input; therefore, other issues relating to hidden effects, adjustment to life after stroke, and secondary prevention are seldom addressed. Changes made based on your suggestion: National Clinical Guidelines for Stroke (2023) recommend that all people after stroke should receive a holistic and structured 6-month review (4). People with a diagnosis of TIA are seldom offered this review and it can be more challenging for these individuals to access community stroke services. Ref added: 4. Intercollegiate Stroke Working Party. National Clinical Guideline for Stroke for the UK and Ireland London2023 [Available from: https://www.strokeguideline.org/app/uploads/2023/04/National-Clinical-Guideline-for-Stroke-2023.pdf 7. Your suggestion:

It would be useful to the reader to include a table outlining what the different NIHSS scores mean, similar to the table describing the MRS. Also, a key is needed for the abbreviations in each of the tables. Our response: We have now added Table 1 with the NIHSS scores as suggested. We have also included abbreviations in a key for each of the tables. Changes made based on your suggestions: The information below is presented in a table in the manuscript. Table 1: Stroke severity - National Institute of Health Stroke Scale Score 0 = No Stroke symptoms 0-4 = Minor Stroke 5-15 = Moderate Stroke 16-20 = Moderate to Severe Stroke 21-42 = Severe stroke Ref added: 5. Zhuo Y, Qu Y, Wu J, Huang X, Yuan W, Lee J, et al. Estimation of stroke severity with National Institutes of Health Stroke Scale grading and retinal features: A cross-sectional study. Medicine (Baltimore). 2021;100(31):e26846. Table 2. Participant data collection domains Key: mRS-modified Rankin Scale, PHQ2-patient health questionnaire 2, EDI-ethnicity, diversity and inclusion, NIHSS-National Institute of Health Stroke Scale, MoCA-Montreal cognitive assessment. Table 4: Schedule of Events Table Key: HCCQ-Healthcare Climate Questionnaire, PROMIS-10-Patient-reported outcome measurement information system, PEI-Patient enablement instrument, SA01- Substantial amendment 1, mRS-modified Rankin scale, PHQ2-Patient health questionnaire 2, PHQ9-Patient health questionnaire 9, GAD7-Generalised anxiety disorderDear Dr MerrimanCompeting Interests: No competing interests Close Thank you for the time you have taken to review this paper and for your helpful comments. Please find our response below to all the points you have raised. We present each suggestion you have made or question you have asked and then the relevant current text in the manuscript. We then present the changes we have made based on your suggestions. Text added to the original manuscript is underlined. 1.Your suggestion:

I would be explicit that the NIHR/MRC framework for complex intervention development and the framework of actions informed the design of the intervention. Current text: This complex intervention is underpinned by self-determination theory, which forms a framework for delivery of the intervention. Changes made based on your suggestion: The design of this complex intervention is informed by the NIHR/MRC framework for complex intervention development and the framework of action described by Alicia O’Cathain and colleagues. The intervention is underpinned by self-determination theory, which forms a framework for delivery of the intervention. 2. Your suggestion:

Under the heading ‘what is a minor stroke?’, I would recommend defining transient ischaemic attack at this stage. It would also be useful to the reader to know what similarities and differences in treatment there are for minor stroke or TIA and stroke as well. Current text: In this feasibility study, we will use the tissue-based definition for minor stroke (a stroke visible on imaging), and in terms of impairment scores we will recruit patients with a National Institute of Health Stroke Scale (NIHSS) score ≤ five at 24 hours post admission. Changes made based on your suggestions: In this feasibility study, we will use the tissue-based definition for minor stroke (a stroke visible on brain imaging). The definition we use for TIA is the presence of transient neurological symptoms which appear to have fully resolved within 24 hours and the absence of tissue damage on brain imaging. The National Institute for Health Stroke Scale (NIHSS) score is an impairment scale which is widely used in clinical practice and research to define minor, moderate or severe stroke (see Table 1)(1). The most commonly used cut off points for minor stroke in research studies are NIHSS ≤ 3 or NIHSS ≤ 5(2).We will be using NIHSS ≤ 5 as our cut off point in this study. In our service the medical management of those with both minor stroke and TIA focuses on the identification and management of vascular risk factors. Both people with a diagnosis of TIA or minor stroke will have a therapy assessment on the HASU. Only those with a minor stroke are referred for a six-month stroke review. Community stroke therapy teams that subscribe to the time-based definition for TIA will usually not accept referrals for people with a diagnosis of TIA. Ref added: 1. Schwartz JK, Capo-Lugo CE, Akinwuntan AE, Roberts P, Krishnan S, Belagaje SR, et al. Classification of Mild Stroke: A Mapping Review. PM R. 2019;11(9):996-1003. Ref added: 2. Leng X, Wang D. Editorial: minor stroke is not minor. Stroke Vasc Neurol. 2023;8(3):175-7. 3. Your question:

In this section, the authors state they will recruit patients with an NIHSS score of ≤5 at 24 hours post-admission, however the eligibility criteria specify an NIHSS score of ≤5 at 2 hours post-post. It would be good to clarify the time point and move this information to the methods section. Our response: Thank you for highlighting this inconsistency, we have now corrected this. The correct time point is NIHSS score of ≤5 at 2 hours post admission. Changes made based on your suggestion: We have moved this to:

Setting Recruitment: Participants with NIHSS score of ≤5 at 2 hours post admission and meeting the other inclusion criteria will be recruited from the HASU and RAC. 4. Your suggestion:

The authors discuss their aim mid-introduction and that is best placed with the study objectives section. Our response: We agree that this should be in the study objectives section and so this has been removed from the introduction and placed in the study objectives section. 5. Your suggestion:

I think it would be worthwhile to include a definition of complex interventions. Our response: We agree that including a definition of complex interventions will enhance the manuscript. Current text: nothing explained about what a complex intervention is in the original text. Changes made based on your suggestion: We have added a short paragraph in the introduction section between the paragraph ‘What is a minor stroke?’ and the paragraph ‘What happens in current practice?’ which we have headed with ‘What is a complex intervention?’ What is a complex intervention? Many interventions used in healthcare are considered to be complex interventions, whereby the intervention consists of a number of different interacting components, each targeting different areas of behavioural change or aspects of health and wellbeing. Complex interventions allow a degree of flexibility as they are applied in different contexts or different systems to a wide range of individuals with varying levels of health literacy and from a diverse range of communities (3). Ref added: 3. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374: n2061 6. Your suggestion:

I think some more information on what constitutes usual care would be informative to the reader. The authors mention the 6-week review, but it would be good to include the National Clinical Guidelines for Stroke recommendation of 6-month stroke review as well since this is the usual care timeframe mentioned in the methods section. Our response: We have added information on the 6-month stroke review which is offered as part of usual care in the methods section. Current text: Current medical follow-up appointments are brief and focus specifically on medical issues and outstanding medical investigations. Ideally, these should occur 6 weeks post-discharge, but in practice, the wait for these appointments is often longer. These appointments rarely have multidisciplinary input; therefore, other issues relating to hidden effects, adjustment to life after stroke, and secondary prevention are seldom addressed. Changes made based on your suggestion: National Clinical Guidelines for Stroke (2023) recommend that all people after stroke should receive a holistic and structured 6-month review (4). People with a diagnosis of TIA are seldom offered this review and it can be more challenging for these individuals to access community stroke services. Ref added: 4. Intercollegiate Stroke Working Party. National Clinical Guideline for Stroke for the UK and Ireland London2023 [Available from: https://www.strokeguideline.org/app/uploads/2023/04/National-Clinical-Guideline-for-Stroke-2023.pdf 7. Your suggestion:

It would be useful to the reader to include a table outlining what the different NIHSS scores mean, similar to the table describing the MRS. Also, a key is needed for the abbreviations in each of the tables. Our response: We have now added Table 1 with the NIHSS scores as suggested. We have also included abbreviations in a key for each of the tables. Changes made based on your suggestions: The information below is presented in a table in the manuscript. Table 1: Stroke severity - National Institute of Health Stroke Scale Score 0 = No Stroke symptoms 0-4 = Minor Stroke 5-15 = Moderate Stroke 16-20 = Moderate to Severe Stroke 21-42 = Severe stroke Ref added: 5. Zhuo Y, Qu Y, Wu J, Huang X, Yuan W, Lee J, et al. Estimation of stroke severity with National Institutes of Health Stroke Scale grading and retinal features: A cross-sectional study. Medicine (Baltimore). 2021;100(31):e26846. Table 2. Participant data collection domains Key: mRS-modified Rankin Scale, PHQ2-patient health questionnaire 2, EDI-ethnicity, diversity and inclusion, NIHSS-National Institute of Health Stroke Scale, MoCA-Montreal cognitive assessment. Table 4: Schedule of Events Table Key: HCCQ-Healthcare Climate Questionnaire, PROMIS-10-Patient-reported outcome measurement information system, PEI-Patient enablement instrument, SA01- Substantial amendment 1, mRS-modified Rankin scale, PHQ2-Patient health questionnaire 2, PHQ9-Patient health questionnaire 9, GAD7-Generalised anxiety disorder COMMENTS ON THIS REPORT - Author Response 26 Feb 2025Jennifer Crow, Department of Occupational Therapy and Physiotherapy, Imperial College Healthcare NHS Trust, London, UK26 Feb 2025Author ResponseDear Dr Merriman Thank you for the time you have taken to review this paper and for your helpful comments. Please find our response below to all the points you ... Continue reading Dear Dr Merriman Thank you for the time you have taken to review this paper and for your helpful comments. Please find our response below to all the points you have raised. We present each suggestion you have made or question you have asked and then the relevant current text in the manuscript. We then present the changes we have made based on your suggestions. Text added to the original manuscript is underlined. 1.Your suggestion:

I would be explicit that the NIHR/MRC framework for complex intervention development and the framework of actions informed the design of the intervention. Current text: This complex intervention is underpinned by self-determination theory, which forms a framework for delivery of the intervention. Changes made based on your suggestion: The design of this complex intervention is informed by the NIHR/MRC framework for complex intervention development and the framework of action described by Alicia O’Cathain and colleagues. The intervention is underpinned by self-determination theory, which forms a framework for delivery of the intervention. 2. Your suggestion:

Under the heading ‘what is a minor stroke?’, I would recommend defining transient ischaemic attack at this stage. It would also be useful to the reader to know what similarities and differences in treatment there are for minor stroke or TIA and stroke as well. Current text: In this feasibility study, we will use the tissue-based definition for minor stroke (a stroke visible on imaging), and in terms of impairment scores we will recruit patients with a National Institute of Health Stroke Scale (NIHSS) score ≤ five at 24 hours post admission. Changes made based on your suggestions: In this feasibility study, we will use the tissue-based definition for minor stroke (a stroke visible on brain imaging). The definition we use for TIA is the presence of transient neurological symptoms which appear to have fully resolved within 24 hours and the absence of tissue damage on brain imaging. The National Institute for Health Stroke Scale (NIHSS) score is an impairment scale which is widely used in clinical practice and research to define minor, moderate or severe stroke (see Table 1)(1). The most commonly used cut off points for minor stroke in research studies are NIHSS ≤ 3 or NIHSS ≤ 5(2).We will be using NIHSS ≤ 5 as our cut off point in this study. In our service the medical management of those with both minor stroke and TIA focuses on the identification and management of vascular risk factors. Both people with a diagnosis of TIA or minor stroke will have a therapy assessment on the HASU. Only those with a minor stroke are referred for a six-month stroke review. Community stroke therapy teams that subscribe to the time-based definition for TIA will usually not accept referrals for people with a diagnosis of TIA. Ref added: 1. Schwartz JK, Capo-Lugo CE, Akinwuntan AE, Roberts P, Krishnan S, Belagaje SR, et al. Classification of Mild Stroke: A Mapping Review. PM R. 2019;11(9):996-1003. Ref added: 2. Leng X, Wang D. Editorial: minor stroke is not minor. Stroke Vasc Neurol. 2023;8(3):175-7. 3. Your question:

In this section, the authors state they will recruit patients with an NIHSS score of ≤5 at 24 hours post-admission, however the eligibility criteria specify an NIHSS score of ≤5 at 2 hours post-post. It would be good to clarify the time point and move this information to the methods section. Our response: Thank you for highlighting this inconsistency, we have now corrected this. The correct time point is NIHSS score of ≤5 at 2 hours post admission. Changes made based on your suggestion: We have moved this to:

Setting Recruitment: Participants with NIHSS score of ≤5 at 2 hours post admission and meeting the other inclusion criteria will be recruited from the HASU and RAC. 4. Your suggestion:

The authors discuss their aim mid-introduction and that is best placed with the study objectives section. Our response: We agree that this should be in the study objectives section and so this has been removed from the introduction and placed in the study objectives section. 5. Your suggestion:

I think it would be worthwhile to include a definition of complex interventions. Our response: We agree that including a definition of complex interventions will enhance the manuscript. Current text: nothing explained about what a complex intervention is in the original text. Changes made based on your suggestion: We have added a short paragraph in the introduction section between the paragraph ‘What is a minor stroke?’ and the paragraph ‘What happens in current practice?’ which we have headed with ‘What is a complex intervention?’ What is a complex intervention? Many interventions used in healthcare are considered to be complex interventions, whereby the intervention consists of a number of different interacting components, each targeting different areas of behavioural change or aspects of health and wellbeing. Complex interventions allow a degree of flexibility as they are applied in different contexts or different systems to a wide range of individuals with varying levels of health literacy and from a diverse range of communities (3). Ref added: 3. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374: n2061 6. Your suggestion:

I think some more information on what constitutes usual care would be informative to the reader. The authors mention the 6-week review, but it would be good to include the National Clinical Guidelines for Stroke recommendation of 6-month stroke review as well since this is the usual care timeframe mentioned in the methods section. Our response: We have added information on the 6-month stroke review which is offered as part of usual care in the methods section. Current text: Current medical follow-up appointments are brief and focus specifically on medical issues and outstanding medical investigations. Ideally, these should occur 6 weeks post-discharge, but in practice, the wait for these appointments is often longer. These appointments rarely have multidisciplinary input; therefore, other issues relating to hidden effects, adjustment to life after stroke, and secondary prevention are seldom addressed. Changes made based on your suggestion: National Clinical Guidelines for Stroke (2023) recommend that all people after stroke should receive a holistic and structured 6-month review (4). People with a diagnosis of TIA are seldom offered this review and it can be more challenging for these individuals to access community stroke services. Ref added: 4. Intercollegiate Stroke Working Party. National Clinical Guideline for Stroke for the UK and Ireland London2023 [Available from: https://www.strokeguideline.org/app/uploads/2023/04/National-Clinical-Guideline-for-Stroke-2023.pdf 7. Your suggestion:

It would be useful to the reader to include a table outlining what the different NIHSS scores mean, similar to the table describing the MRS. Also, a key is needed for the abbreviations in each of the tables. Our response: We have now added Table 1 with the NIHSS scores as suggested. We have also included abbreviations in a key for each of the tables. Changes made based on your suggestions: The information below is presented in a table in the manuscript. Table 1: Stroke severity - National Institute of Health Stroke Scale Score 0 = No Stroke symptoms 0-4 = Minor Stroke 5-15 = Moderate Stroke 16-20 = Moderate to Severe Stroke 21-42 = Severe stroke Ref added: 5. Zhuo Y, Qu Y, Wu J, Huang X, Yuan W, Lee J, et al. Estimation of stroke severity with National Institutes of Health Stroke Scale grading and retinal features: A cross-sectional study. Medicine (Baltimore). 2021;100(31):e26846. Table 2. Participant data collection domains Key: mRS-modified Rankin Scale, PHQ2-patient health questionnaire 2, EDI-ethnicity, diversity and inclusion, NIHSS-National Institute of Health Stroke Scale, MoCA-Montreal cognitive assessment. Table 4: Schedule of Events Table Key: HCCQ-Healthcare Climate Questionnaire, PROMIS-10-Patient-reported outcome measurement information system, PEI-Patient enablement instrument, SA01- Substantial amendment 1, mRS-modified Rankin scale, PHQ2-Patient health questionnaire 2, PHQ9-Patient health questionnaire 9, GAD7-Generalised anxiety disorderDear Dr MerrimanCompeting Interests: No competing interests Close Thank you for the time you have taken to review this paper and for your helpful comments. Please find our response below to all the points you have raised. We present each suggestion you have made or question you have asked and then the relevant current text in the manuscript. We then present the changes we have made based on your suggestions. Text added to the original manuscript is underlined. 1.Your suggestion:

I would be explicit that the NIHR/MRC framework for complex intervention development and the framework of actions informed the design of the intervention. Current text: This complex intervention is underpinned by self-determination theory, which forms a framework for delivery of the intervention. Changes made based on your suggestion: The design of this complex intervention is informed by the NIHR/MRC framework for complex intervention development and the framework of action described by Alicia O’Cathain and colleagues. The intervention is underpinned by self-determination theory, which forms a framework for delivery of the intervention. 2. Your suggestion:

Under the heading ‘what is a minor stroke?’, I would recommend defining transient ischaemic attack at this stage. It would also be useful to the reader to know what similarities and differences in treatment there are for minor stroke or TIA and stroke as well. Current text: In this feasibility study, we will use the tissue-based definition for minor stroke (a stroke visible on imaging), and in terms of impairment scores we will recruit patients with a National Institute of Health Stroke Scale (NIHSS) score ≤ five at 24 hours post admission. Changes made based on your suggestions: In this feasibility study, we will use the tissue-based definition for minor stroke (a stroke visible on brain imaging). The definition we use for TIA is the presence of transient neurological symptoms which appear to have fully resolved within 24 hours and the absence of tissue damage on brain imaging. The National Institute for Health Stroke Scale (NIHSS) score is an impairment scale which is widely used in clinical practice and research to define minor, moderate or severe stroke (see Table 1)(1). The most commonly used cut off points for minor stroke in research studies are NIHSS ≤ 3 or NIHSS ≤ 5(2).We will be using NIHSS ≤ 5 as our cut off point in this study. In our service the medical management of those with both minor stroke and TIA focuses on the identification and management of vascular risk factors. Both people with a diagnosis of TIA or minor stroke will have a therapy assessment on the HASU. Only those with a minor stroke are referred for a six-month stroke review. Community stroke therapy teams that subscribe to the time-based definition for TIA will usually not accept referrals for people with a diagnosis of TIA. Ref added: 1. Schwartz JK, Capo-Lugo CE, Akinwuntan AE, Roberts P, Krishnan S, Belagaje SR, et al. Classification of Mild Stroke: A Mapping Review. PM R. 2019;11(9):996-1003. Ref added: 2. Leng X, Wang D. Editorial: minor stroke is not minor. Stroke Vasc Neurol. 2023;8(3):175-7. 3. Your question:

In this section, the authors state they will recruit patients with an NIHSS score of ≤5 at 24 hours post-admission, however the eligibility criteria specify an NIHSS score of ≤5 at 2 hours post-post. It would be good to clarify the time point and move this information to the methods section. Our response: Thank you for highlighting this inconsistency, we have now corrected this. The correct time point is NIHSS score of ≤5 at 2 hours post admission. Changes made based on your suggestion: We have moved this to:

Setting Recruitment: Participants with NIHSS score of ≤5 at 2 hours post admission and meeting the other inclusion criteria will be recruited from the HASU and RAC. 4. Your suggestion:

The authors discuss their aim mid-introduction and that is best placed with the study objectives section. Our response: We agree that this should be in the study objectives section and so this has been removed from the introduction and placed in the study objectives section. 5. Your suggestion:

I think it would be worthwhile to include a definition of complex interventions. Our response: We agree that including a definition of complex interventions will enhance the manuscript. Current text: nothing explained about what a complex intervention is in the original text. Changes made based on your suggestion: We have added a short paragraph in the introduction section between the paragraph ‘What is a minor stroke?’ and the paragraph ‘What happens in current practice?’ which we have headed with ‘What is a complex intervention?’ What is a complex intervention? Many interventions used in healthcare are considered to be complex interventions, whereby the intervention consists of a number of different interacting components, each targeting different areas of behavioural change or aspects of health and wellbeing. Complex interventions allow a degree of flexibility as they are applied in different contexts or different systems to a wide range of individuals with varying levels of health literacy and from a diverse range of communities (3). Ref added: 3. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374: n2061 6. Your suggestion:

I think some more information on what constitutes usual care would be informative to the reader. The authors mention the 6-week review, but it would be good to include the National Clinical Guidelines for Stroke recommendation of 6-month stroke review as well since this is the usual care timeframe mentioned in the methods section. Our response: We have added information on the 6-month stroke review which is offered as part of usual care in the methods section. Current text: Current medical follow-up appointments are brief and focus specifically on medical issues and outstanding medical investigations. Ideally, these should occur 6 weeks post-discharge, but in practice, the wait for these appointments is often longer. These appointments rarely have multidisciplinary input; therefore, other issues relating to hidden effects, adjustment to life after stroke, and secondary prevention are seldom addressed. Changes made based on your suggestion: National Clinical Guidelines for Stroke (2023) recommend that all people after stroke should receive a holistic and structured 6-month review (4). People with a diagnosis of TIA are seldom offered this review and it can be more challenging for these individuals to access community stroke services. Ref added: 4. Intercollegiate Stroke Working Party. National Clinical Guideline for Stroke for the UK and Ireland London2023 [Available from: https://www.strokeguideline.org/app/uploads/2023/04/National-Clinical-Guideline-for-Stroke-2023.pdf 7. Your suggestion:

It would be useful to the reader to include a table outlining what the different NIHSS scores mean, similar to the table describing the MRS. Also, a key is needed for the abbreviations in each of the tables. Our response: We have now added Table 1 with the NIHSS scores as suggested. We have also included abbreviations in a key for each of the tables. Changes made based on your suggestions: The information below is presented in a table in the manuscript. Table 1: Stroke severity - National Institute of Health Stroke Scale Score 0 = No Stroke symptoms 0-4 = Minor Stroke 5-15 = Moderate Stroke 16-20 = Moderate to Severe Stroke 21-42 = Severe stroke Ref added: 5. Zhuo Y, Qu Y, Wu J, Huang X, Yuan W, Lee J, et al. Estimation of stroke severity with National Institutes of Health Stroke Scale grading and retinal features: A cross-sectional study. Medicine (Baltimore). 2021;100(31):e26846. Table 2. Participant data collection domains Key: mRS-modified Rankin Scale, PHQ2-patient health questionnaire 2, EDI-ethnicity, diversity and inclusion, NIHSS-National Institute of Health Stroke Scale, MoCA-Montreal cognitive assessment. Table 4: Schedule of Events Table Key: HCCQ-Healthcare Climate Questionnaire, PROMIS-10-Patient-reported outcome measurement information system, PEI-Patient enablement instrument, SA01- Substantial amendment 1, mRS-modified Rankin scale, PHQ2-Patient health questionnaire 2, PHQ9-Patient health questionnaire 9, GAD7-Generalised anxiety disorder Views 0 How to cite this report: Reeves M. Reviewer Report For: Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.15013.r33808) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-44/v2#referee-response-33808 https://openresearch.nihr.ac.uk/articles/4-44/v2#referee-response-33808 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 17 Dec 2024 Mathew Reeves, Epidemiology, Michigan State University, East Lansing, Michigan, USA Approved VIEWS 0 I have read the response from the authors and was impressed with the number of substantive changes made to the protocol in response to my prior comments. I now approve the final version of this protocol and wish the authors ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close I have read the response from the authors and was impressed with the number of substantive changes made to the protocol in response to my prior comments. I now approve the final version of this protocol and wish the authors the best of luck for the successful implementation of this important project. Competing Interests: No competing interests were disclosed. CITE HOW TO CITE THIS REPORT Reeves M. Reviewer Report For: Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.15013.r33808) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-44/v2#referee-response-33808 https://openresearch.nihr.ac.uk/articles/4-44/v2#referee-response-33808 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Version 1 VERSION 1 PUBLISHED 01 Aug 2024 Views 0 How to cite this report: Reeves M. Reviewer Report For: Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.14819.r32856) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-44/v1#referee-response-32856 https://openresearch.nihr.ac.uk/articles/4-44/v1#referee-response-32856 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 10 Oct 2024 Mathew Reeves, Epidemiology, Michigan State University, East Lansing, Michigan, USA Approved with Reservations VIEWS 0 This is a well written and formatted protocol for a pilot feasibility study of a post discharge intervention trial to improve recovery in mild stroke patients. The justification for the study was well described with sufficient background materials. A scoping ... Continue reading I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close This is a well written and formatted protocol for a pilot feasibility study of a post discharge intervention trial to improve recovery in mild stroke patients. The justification for the study was well described with sufficient background materials. A scoping review was provided that highlighted the deficiencies of the current published research studies (n= 25) which show an incredible level of heterogeneity in terms of goals, study designs, interventions, outcomes, and results. One thing that could have been given more attention is that few if any interventions to date have shown meaningful improvements in patient outcomes in this population. Other specific critiques include: Two touch points at 2 and 6 weeks is quite limited. Opportunities to continue the dialogue and delivery of services across the 12-week period are probably needed. There appears to be limited use of mHealth technologies to deliver or supplement the intervention, or to collect data. It would be helpful if specific examples of community-based referrals that are available to be accessed within the time period of the intervention were identified. It is unclear if and how GPs are involved in the study? What information will they receive on both the intervention and control subjects? There is also some concern that retention rates will be substantially lower for the control group given that they receive little (or no?) direct contact after enrollment. Investigators should consider adding some minimal ongoing level of engagement with the control group between 2 and 6 weeks. Clarify if the Stroke Association Connect program will be given to both arms? And whether the program itself has been made aware of this trial and the subject’s enrollment? I would suggest that a patient-reported measure of physical function be collected at baseline, 2, 6 and 12 weeks, and also that all baseline data collection is standardized to occur at the same time point (preferably soon after returning home). It is unclear why the outcome assessment is not being done blinded? Explain and justify. What mitigation steps can be taken to reduce bias? Eligibility criteria does not include a baseline NIHSS score? Why is this? What is the maximum time allowed between stroke onset and enrollment? What is the expected total annual stroke case load at the RAC and HASC? Table 3: The >90% recruitment threshold appears to be quite ambitious and may be difficult to reach. Table 4. Add fatigue? The success or failure of studies like this largely depends on how treatment efficacy is measured. Decision on how a primary outcome measure will be selected are far from easy. More details of how qualitative interviews and data responsiveness will be combined to make the choice is required. What are the hypothesized mechanisms where 2 visits focused on unmet needs can really make a difference? Other specific critiques include: Two touch points at 2 and 6 weeks is quite limited. Opportunities to continue the dialogue and delivery of services across the 12-week period are probably needed. There appears to be limited use of mHealth technologies to deliver or supplement the intervention, or to collect data. It would be helpful if specific examples of community-based referrals that are available to be accessed within the time period of the intervention were identified. It is unclear if and how GPs are involved in the study? What information will they receive on both the intervention and control subjects? There is also some concern that retention rates will be substantially lower for the control group given that they receive little (or no?) direct contact after enrollment. Investigators should consider adding some minimal ongoing level of engagement with the control group between 2 and 6 weeks. Clarify if the Stroke Association Connect program will be given to both arms? And whether the program itself has been made aware of this trial and the subject’s enrollment? I would suggest that a patient-reported measure of physical function be collected at baseline, 2, 6 and 12 weeks, and also that all baseline data collection is standardized to occur at the same time point (preferably soon after returning home). It is unclear why the outcome assessment is not being done blinded? Explain and justify. What mitigation steps can be taken to reduce bias? Eligibility criteria does not include a baseline NIHSS score? Why is this? What is the maximum time allowed between stroke onset and enrollment? What is the expected total annual stroke case load at the RAC and HASC? Table 3: The >90% recruitment threshold appears to be quite ambitious and may be difficult to reach. Table 4. Add fatigue? The success or failure of studies like this largely depends on how treatment efficacy is measured. Decision on how a primary outcome measure will be selected are far from easy. More details of how qualitative interviews and data responsiveness will be combined to make the choice is required. What are the hypothesized mechanisms where 2 visits focused on unmet needs can really make a difference? - Is the rationale for, and objectives of, the study clearly described? Yes - Is the study design appropriate for the research question? Yes - Are sufficient details of the methods provided to allow replication by others? Yes - Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Stroke epidemiologist and trialist with experience with stroke transitions. CITE HOW TO CITE THIS REPORT Reeves M. Reviewer Report For: Improving follow-up care for people after minor stroke using early personalised care: A protocol for a randomised, mixed-methods, feasibility study. [version 3; peer review: 2 approved]. NIHR Open Res 2025, 4:44 (https://doi.org/10.3310/nihropenres.14819.r32856) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-44/v1#referee-response-32856 https://openresearch.nihr.ac.uk/articles/4-44/v1#referee-response-32856 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. - Author Response 25 Nov 2024Jennifer Crow, Department of Occupational Therapy and Physiotherapy, Imperial College Healthcare NHS Trust, London, UK25 Nov 2024Author ResponseDear Professor Reeves Thank you for taking the time to review our feasibility study protocol and for the helpful feedback and suggestions you have provided. We have responded to all ... Continue reading Dear Professor Reeves Thank you for taking the time to review our feasibility study protocol and for the helpful feedback and suggestions you have provided. We have responded to all the points you have raised and have made adjustments to our protocol manuscript accordingly to improve the quality, clarity and robustness of the feasibility study being conducted. See below our point-by-point responses to your comments with our responses labelled as 'response' and manuscript adjustments underlined within the original text, both in italics. 1.One thing that could have been given more attention is that few if any interventions to date have shown meaningful improvements in patient outcomes in this population. RESPONSE: Thank you, this is a very important question to address. We have now added an explanation to the manuscript text to provide more clarity on how the scoping review helped us to identify potential key elements for inclusion in our intervention. Specifically, we describe two studies that were able to demonstrate meaningful improvement in HRQOL at 12 months after stroke. In our intervention the key elements that we have included are a multidisciplinary focus, personalised care and self-determination theory. We conducted a scoping review to identify follow-up programmes, pathways, and services that have been developed for people after minor stroke22. Twenty-five studies were included in the analysis. Interventions often focused on education, secondary prevention, and exercise after stroke, whereas the management of hidden impairments and adjustment to life after stroke were less likely to be addressed. These complex interventions were often poorly described, and descriptions of family involvement, liaison between primary and secondary care, and underpinning psychological or behavioural theories were lacking. The review revealed that it is still unknown how best to organise services to offer personalised timely support and education to people in the community. There were two RCTs included in the scoping review (STROKECARD(1) and the Taking Charge after Stroke (TACAS) study(2)) that were able to demonstrate improvements in health-related quality of life at 12 months after the stroke. STROKECARD involved personalised, comprehensive multidisciplinary follow-up at 3 months post stroke and the TACAS follow-up intervention was underpinned by self-determination theory and involved either one or two follow-up appointments. TACAS’s person centred intervention focused on supporting a person to take charge of their recovery through supporting self-empowerment. The key elements from these two studies; multidisciplinary focus, personalised care and self-determination theory are included in the intervention described in this protocol. We believe that this may increase the likelihood of being able to show meaningful improvements in this diverse patient population. 2. Two touch points at 2 and 6 weeks is quite limited. Opportunities to continue the dialogue and delivery of services across the 12-week period are probably needed. RESPONSE: Thank you for this point. The two follow-up appointments are supplemented by direct mobile phone access to the researcher which enables participants to discuss any questions or concerns that arise during the 12-week duration of the study. The researcher in turn has direct access to the clinical team, including the stroke clinical specialist nurses if medical concerns are raised. This is novel because currently it is very difficult to have any ad hoc contact with the stroke clinical team after discharge. Contact is restricted to the follow-up medical appointment which could be 12 weeks after discharge. Due to substantial pressures within primary care, GPs are currently very difficult to access directly, and they often direct questions back to the specialist stroke service. I have provided further clarification of this in the manuscript text as below. The intervention is composed of two follow-up appointments and telephone access to the researcher to address questions that may arise between appointments. The researcher has direct access to the clinical team and stroke clinical specialist nurses if medical concerns are raised. This may help to address feelings of abandonment that are frequently described in the literature. Currently it is very difficult to have ad hoc contact with the stroke clinical team after discharge. The fomal follow-up appointments will occur at 2 and 6 weeks after recruitment and will last from 30 to 60 min, depending on the identified needs. 3. There appears to be limited use of mHealth technologies to deliver or supplement the intervention, or to collect data. RESPONSE: Thank you for raising this important question. We recognise the increasing relevance of these approaches, but in order to be inclusive and avoid digital exclusion we have limited the essential use of mHealth technologies in the intervention delivery and outcome measurement. The option does exist for the follow-up appointments to be conducted virtually as well as the outcome measurement at 12 weeks. In these cases, the participants will be sent electronic versions of the patient reported outcome measures. We will not be excluding the use of online resources and digital Apps but will only signpost participants to them when they are familiar with, and have easy access to, these technologies. In this way we hope to provide accessible and personally tailored follow-up. Below we have tried to make this clearer in the manuscript. To ensure the delivery of a personalised intervention, follow-up appointments will be offered face-to-face in person at the hospital, participant’s home, or a neutral venue in the community, or as a telephone or video call/virtual appointment. Participants will have the option of completing their twelve-week outcome measurement in person or alternatively electronic versions of the outcome measures will be sent to participants for their completion. The preferred modality will be noted and will inform a future definitive trial. Where signposting to online information resources or digital Apps is indicated this will form part of the intervention. This will however only be utilized with those that are familiar with and have easy access to these technologies. 4. It would be helpful if specific examples of community-based referrals that are available to be accessed within the time period of the intervention were identified. RESPONSE: We have now clarified this in the manuscript text as below, in the ‘How, when and where’ section of the text which describes what is covered in the follow-up appointments. A GP could potentially also make these referrals but given that a GP appointment in the UK is 9 minutes long it is unlikely that they will have the opportunity to gauge what a person’s post-stroke functional, cognitive or psychological problems might be and they will therefore be unlikely to initiate referrals for ongoing community stroke therapy. Examples of onward community-based referrals that may be indicated include referral to the community stroke therapy team. This may be indicated when the person is back at home and engaging in their everyday activities and then becomes aware of higher-level difficulties that were not detected initially. The hidden impacts of stroke such as fatigue and mood issues are also more likely to become apparent after a period of time at home. Within the UK and Ireland the National Clinical Guidelines for Stroke (2023) now support the need for referral for ongoing rehabilitation at any time point after a stroke if new goals are identified. Other referrals to voluntary sector organisations for information, peer support or exercise groups can also be made if indicated. 5. It is unclear if and how GPs are involved in the study? What information will they receive on both the intervention and control subjects? RESPONSE: The GPs will be informed via letter if one of their patients is involved in this study. They will be informed if the person is in the intervention or control group and will be provided with information on the purpose of the study and what it involves. Contact details of the researcher will also be available on the letter. Following the 1st and 2nd follow-up appointments the GP will receive a summary letter with the topics discussed and action plan agreed. To be included in the materials and procedures section: The participant's GP will be informed of their involvement in the study and which group they have been randomised to. A brief description of the purpose of the study and what it involves, as well as the research team’s contact details, will be included in the letter sent to the GP. Appointment 1: Written summary sent to GP with topics discussed and action plan agreed. Appointment 2: Written summary and plan to be sent to GP with topics discussed and action plan agreed. 6. There is also some concern that retention rates will be substantially lower for the control group given that they receive little (or no?) direct contact after enrollment. Investigators should consider adding some minimal ongoing level of engagement with the control group between 2 and 6 weeks. RESPONSE: The ongoing engagement with the control group will be the provision of the mobile number and email address of the researcher. Participants will be informed that they can contact the researcher at any time during the 12-week duration of the study if they have questions arising related to their stroke or its effects. Under normal circumstances it is not possible to have contact with the acute team once a person has left the hospital. All concerns need to be directed to the GP, but GPs may not have received the hospital discharge summary and because the IT systems are not linked they are unable to see what upcoming investigations and appointments have been booked. Having direct access to a professional based in the acute setting is therefore advantageous and offers the opportunity for an ongoing level of engagement. Adjustments made in response to question 2 also provide information on how this will provide an ongoing level of engagement. Control group The participants in the control group will receive standard care. This involves the provision of a printed information sheet on therapy services that exist in their locality and referral to the Stroke Association Connect service, which makes telephone contact with the person after discharge. A six-month stroke review referral is also sent, but currently, this is not consistently provided across all localities. In addition to standard care, those in the control group will be provided with a mobile telephone number and email address for the lead researcher to enable easy contact during the 12-week duration of the study if questions arise relating to their stroke or its effects. If referrals onto community stroke therapy services are indicated at the 12-week outcome measurement appointment, then they will be made at that time. 7. Clarify if the Stroke Association Connect program will be given to both arms? And whether the program itself has been made aware of this trial and the subject’s enrolment? RESPONSE: Both arms are referred to the Stroke Association Connect programme. This programme involves a follow-up telephone call to the person after stroke between 2-4 weeks after the event. The Stroke Association connector provides reassurance, guidance with any immediate concerns, and connects people to ongoing peer support. The connector is not medically trained, and they are not provided with any of the persons medical details except that they have had a stroke. If any medical questions arise the person is directed to speak to their GP. This is part of usual care, and the connector will not routinely be informed of the participants' involvement in the study. The intervention is composed of two follow-up appointments and telephone access to the researcher to address questions that may arise between appointments. Participants in this group will receive referral to the Stroke Association Connect Service and six-month stroke review referrals as part of standard care. Follow-up appointments will occur at 2 and 6 weeks after recruitment and will last from 30 to 60 min, depending on the need. 8. I would suggest that a patient-reported measure of physical function be collected at baseline, 2, 6 and 12 weeks, and also that all baseline data collection is standardized to occur at the same time point (preferably soon after returning home). RESPONSE: Thank you for this suggestion. We are using the PROMIS10 Global Health patient-reported measure, and this will give a physical health and mental health score at 2 weeks and 12 weeks. This measure is not being used at baseline because participants will largely be recruited within one or two days of their stroke and therefore may not yet have a sense of how their physical function and mental health has been impacted. The modified Rankin Scale is being gathered to give an indication of pre-stroke physical function. As you have highlighted it is important to standardize the timepoint at which the baseline data is collected, we have now included this in the manuscript text. As this is a feasibility study, we are providing a 1 week window from diagnosis to baseline assessment (either in hospital or a few days after getting home). This will enable us to understand participant preference and through qualitative interviews explore the participants' perspective on having the baseline assessments at home versus when still in hospital. Outcome measurement: Baseline measures for both groups will be conducted by the OT researcher in the hospital where possible, but if the person is discharged quickly or seen in the RAC, then they will be conducted at the persons home or in the clinic. Baseline assessment will be conducted within 1 week of the stroke. The location of the final outcome measurement will be agreed upon with the participant and could be in their home or in the hospital. 9. It is unclear why the outcome assessment is not being done blinded? Explain and justify. What mitigation steps can be taken to reduce bias? RESPONSE: Thank you, this is an important point. As this feasibility study is part of a PhD, there is only funding available for one researcher and therefore all measurement and delivery of the intervention is being conducted by the same person. If the results suggest that a future funded definitive trial is possible then outcome assessment will be blinded as there will be a team involved in delivering the study. In this feasibility study the focus is on the feasibility objectives of recruitment, adherence and retention rather than any efficacy measures. However, in acknowledgement of the reviewer's point we have now included in the manuscript an acknowledgement that an unblinded outcome assessor can introduce bias. The responsiveness of the outcome measures to change will be reviewed using confidence intervals for changes from baseline in each group and for between-group comparisons of changes. The numerical results and perceived relevance of the outcome measures used in this feasibility study will be considered. It should be noted that for the current feasibility study the outcome assessor is not blinded, and this has the potential to introduce bias in the assessment. The plan for a future definitive trial would involve a blinded outcome assessor. 10. Eligibility criteria does not include a baseline NIHSS score? Why is this? What is the maximum time allowed between stroke onset and enrolment? RESPONSE: Thank you for highlighting this and this is an omission on our part. We have now added this to the inclusion criteria: NIHSS ≤ 5 at 2 hours post admission to allow those that have had hyperacute interventions and done well to be included in the study. We have also now clarified in the inclusion criteria the maximum time allowed between stroke onset and enrolment. Eligibility criteria Inclusion criteria • Adult ≥18 • Clinical or radiological diagnosis of minor stroke from a stroke consultant. • Admitted to HASU or seen in RAC. • Pre-admission modified Rankin Score (mRS) of 0-3 (see table below), with no formal package of care prior to stroke. Table 1. Modified Rankin Scale scores- NIHSS ≤ 5 at 2 hours post admission - Within one week of receiving stroke diagnosis • No onward referral to community therapy team or for package of care. • Has capacity to consent. 11.What is the expected total annual stroke case load at the RAC and HASU? RESPONSE: Our hyperacute stroke unit (HASU) has approximately 1700 admissions per year, about 1400 of which end up with a diagnosis of stroke. The Rapid Assessment Clinic receives about 160 – 175 referrals every month, of which 50 – 60 are rejected. Many of the referrals are stroke mimics, some are TIA and about 5 per month receive a diagnosis of minor stroke. 12. Table 3: The >90% recruitment threshold appears to be quite ambitious and may be difficult to reach. RESPONSE: Thank you for this comment and you are correct that it is an ambitious target. We believe that this target for this feasibility study may be achievable for the following reasons: - It is only conducted at a single centre and the researcher has good working relationships with both the stroke medical and therapy teams. - We have done extensive outreach work with diverse community groups which has improved our understanding of culturally appropriate ways to approach patients from different communities. We believe that this may result in more successful recruitment of participants that reflect the stroke demographic. - The personalised nature of the intervention and flexible follow-up appointment arrangements were designed to cause minimum disruption to a person’s daily life, caring responsibilities and work routines. The targets may seem ambitious, but due to the limited number of appointments and personalised nature of the intervention, where participants do not need to attend appointments at the hospital, we believe these are achievable. We have carried out extensive work with diverse community groups that has improved our understanding of culturally appropriate ways to approach patients from different communities. Further, this is also a single-centre study, with the lead researcher having established working relationships with the other members of the stroke team. 13. Table 4. Add fatigue? RESPONSE: As you highlight through this suggestion, fatigue is a commonly reported problem after minor stroke. In order to keep the burden of outcome measure completion as low as possible for the feasibility study we decided that rather than include an additional separate fatigue outcome measure, we would utilise the fatigue question included in the PROMIS-10 v1.2 ('In the past 7 days how would you rate your fatigue on average?') In any future definitive trial, we would include a measure of fatigue that provides more granularity rather than solely determining whether it is present. 14. The success or failure of studies like this largely depends on how treatment efficacy is measured. Decision on how a primary outcome measure will be selected are far from easy. More details of how qualitative interviews and data responsiveness will be combined to make the choice is required. RESPONSE: This will be one of the most important and challenging questions to answer when moving from the current feasibility study to a definitive trial. Thus, a stated secondary objective in this feasibility study is to determine what outcome measures should be used for a future efficacy trial. We will be looking at a number of factors:- Accessibility: are participants able to understand and complete the outcome measures without support? When extra support is required does this relate to language or understanding of concepts or something different to these. - Responsiveness to change: we will review the quantitative outcome measures to understand if they reflect any change within and between groups over the duration of the study. - Qualitative interviews: we will look at how the scores on patient reported outcome measures align with what people report in the qualitative interviews. We will need to explore whether the themes that arise from the qualitative data are captured in the quantitative measures used. - Below we provide a more detailed description of how we propose to select a primary outcome measure. Qualitative data analysis Participants in the control and intervention groups will be invited to participate in qualitative, semi-structured interviews. The focus of this will be to explore and understand the experience of receiving a diagnosis of stroke and life after stroke for those who received the intervention and those who did not. We will seek to understand whether the intervention delivered was acceptable and how it could be improved. Alongside this we will review the quantitative measures alongside subjective reports from participants to evaluate whether there is alignment of the qualitative perspectives and quantitative results. The planned purposive sampling strategy will enable the researcher to interview those who seemed to cope well with the transition back to their lives as well as those that appear to be having more adjustment difficulties. This will capture a diversity of experiences and perspectives. We will explore whether the themes that arise from the qualitative data are captured in the quantitative measures used. Key concepts and themes that are prominent in the qualitative data will help the researcher to understand what matters to the participants. This also creates an opportunity for participants to introduce topics that may not be reflected in the outcome measures used in the feasibility study. Through these processes we aim to increase the likelihood of identifying a primary outcome for a subsequent definitive trial that is sufficiently nuanced to capture efficacy in a socio-culturally diverse population. 15. What are the hypothesized mechanisms where 2 visits focused on unmet needs can really make a difference? RESPONSE: We agree with the reviewer that the manuscript would be improved with more extensive mechanistic underpinning of the detailed intervention. Below we describe what the proposed mechanisms of action are that underpin how two follow-up appointments might achieve improved knowledge, health and wellbeing. We will add this text to the manuscript after the descriptions of the intervention and tailoring. The hypothesized mechanisms for action are underpinned by self-determination theory (3). This theory posits that we all have three basic psychological needs for competence, autonomy and relatedness and when these are supported a person’s motivation and engagement are improved. The proposed mechanisms of action within the intervention are: 1) Enhanced, personalised communication – this requires listening to and understanding the participants priorities and needs. It requires an understanding of a person’s health literacy and education level. Communication is personalised and adjusted according to the individual’s needs, acknowledging that one approach would not meet everyone’s needs. 2) Partnership working – this approach changes the power dynamic in healthcare interactions and moves away from traditional hierarchical, paternalistic approaches and facilitates the pursuit of personalised goals. It involves linking the participant in with, or referring them on to, other support services in the community. This approach helps to address adjustment to life after stroke and can mitigate against feelings of isolation and abandonment. It aims to support a sense of belonging, feeling cared for and connected with others. 3) Enablement – by focusing on communication and partnership-working a participant is supported to have freedom of choice to engage in actions that are congruent with their values and priorities. They are given the tools and knowledge to influence the outcomes that are important to them. This supports intrinsic motivation to initiate and sustain behaviour that supports health and wellbeing. 1. Willeit P, Toell T, Boehme C, Krebs S, Mayer L, Lang C, et al. STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial. EClinicalMedicine. 2020;25:100476. 2. Fu V, Weatherall M, McPherson K, Taylor W, McRae A, Thomson T, et al. Taking Charge after Stroke: A randomized controlled trial of a person-centered, self-directed rehabilitation intervention. Int J Stroke. 2020:1747493020915144. 3. Ryan R DE. Self-Determination Theory and the Facilitation of Intrinsic Motivation, Social Development, and Well-Being. Am Psychol. 2000;55(1):68-78.Dear Professor ReevesCompeting Interests: No competing interests Close Thank you for taking the time to review our feasibility study protocol and for the helpful feedback and suggestions you have provided. We have responded to all the points you have raised and have made adjustments to our protocol manuscript accordingly to improve the quality, clarity and robustness of the feasibility study being conducted. See below our point-by-point responses to your comments with our responses labelled as 'response' and manuscript adjustments underlined within the original text, both in italics. 1.One thing that could have been given more attention is that few if any interventions to date have shown meaningful improvements in patient outcomes in this population. RESPONSE: Thank you, this is a very important question to address. We have now added an explanation to the manuscript text to provide more clarity on how the scoping review helped us to identify potential key elements for inclusion in our intervention. Specifically, we describe two studies that were able to demonstrate meaningful improvement in HRQOL at 12 months after stroke. In our intervention the key elements that we have included are a multidisciplinary focus, personalised care and self-determination theory. We conducted a scoping review to identify follow-up programmes, pathways, and services that have been developed for people after minor stroke22. Twenty-five studies were included in the analysis. Interventions often focused on education, secondary prevention, and exercise after stroke, whereas the management of hidden impairments and adjustment to life after stroke were less likely to be addressed. These complex interventions were often poorly described, and descriptions of family involvement, liaison between primary and secondary care, and underpinning psychological or behavioural theories were lacking. The review revealed that it is still unknown how best to organise services to offer personalised timely support and education to people in the community. There were two RCTs included in the scoping review (STROKECARD(1) and the Taking Charge after Stroke (TACAS) study(2)) that were able to demonstrate improvements in health-related quality of life at 12 months after the stroke. STROKECARD involved personalised, comprehensive multidisciplinary follow-up at 3 months post stroke and the TACAS follow-up intervention was underpinned by self-determination theory and involved either one or two follow-up appointments. TACAS’s person centred intervention focused on supporting a person to take charge of their recovery through supporting self-empowerment. The key elements from these two studies; multidisciplinary focus, personalised care and self-determination theory are included in the intervention described in this protocol. We believe that this may increase the likelihood of being able to show meaningful improvements in this diverse patient population. 2. Two touch points at 2 and 6 weeks is quite limited. Opportunities to continue the dialogue and delivery of services across the 12-week period are probably needed. RESPONSE: Thank you for this point. The two follow-up appointments are supplemented by direct mobile phone access to the researcher which enables participants to discuss any questions or concerns that arise during the 12-week duration of the study. The researcher in turn has direct access to the clinical team, including the stroke clinical specialist nurses if medical concerns are raised. This is novel because currently it is very difficult to have any ad hoc contact with the stroke clinical team after discharge. Contact is restricted to the follow-up medical appointment which could be 12 weeks after discharge. Due to substantial pressures within primary care, GPs are currently very difficult to access directly, and they often direct questions back to the specialist stroke service. I have provided further clarification of this in the manuscript text as below. The intervention is composed of two follow-up appointments and telephone access to the researcher to address questions that may arise between appointments. The researcher has direct access to the clinical team and stroke clinical specialist nurses if medical concerns are raised. This may help to address feelings of abandonment that are frequently described in the literature. Currently it is very difficult to have ad hoc contact with the stroke clinical team after discharge. The fomal follow-up appointments will occur at 2 and 6 weeks after recruitment and will last from 30 to 60 min, depending on the identified needs. 3. There appears to be limited use of mHealth technologies to deliver or supplement the intervention, or to collect data. RESPONSE: Thank you for raising this important question. We recognise the increasing relevance of these approaches, but in order to be inclusive and avoid digital exclusion we have limited the essential use of mHealth technologies in the intervention delivery and outcome measurement. The option does exist for the follow-up appointments to be conducted virtually as well as the outcome measurement at 12 weeks. In these cases, the participants will be sent electronic versions of the patient reported outcome measures. We will not be excluding the use of online resources and digital Apps but will only signpost participants to them when they are familiar with, and have easy access to, these technologies. In this way we hope to provide accessible and personally tailored follow-up. Below we have tried to make this clearer in the manuscript. To ensure the delivery of a personalised intervention, follow-up appointments will be offered face-to-face in person at the hospital, participant’s home, or a neutral venue in the community, or as a telephone or video call/virtual appointment. Participants will have the option of completing their twelve-week outcome measurement in person or alternatively electronic versions of the outcome measures will be sent to participants for their completion. The preferred modality will be noted and will inform a future definitive trial. Where signposting to online information resources or digital Apps is indicated this will form part of the intervention. This will however only be utilized with those that are familiar with and have easy access to these technologies. 4. It would be helpful if specific examples of community-based referrals that are available to be accessed within the time period of the intervention were identified. RESPONSE: We have now clarified this in the manuscript text as below, in the ‘How, when and where’ section of the text which describes what is covered in the follow-up appointments. A GP could potentially also make these referrals but given that a GP appointment in the UK is 9 minutes long it is unlikely that they will have the opportunity to gauge what a person’s post-stroke functional, cognitive or psychological problems might be and they will therefore be unlikely to initiate referrals for ongoing community stroke therapy. Examples of onward community-based referrals that may be indicated include referral to the community stroke therapy team. This may be indicated when the person is back at home and engaging in their everyday activities and then becomes aware of higher-level difficulties that were not detected initially. The hidden impacts of stroke such as fatigue and mood issues are also more likely to become apparent after a period of time at home. Within the UK and Ireland the National Clinical Guidelines for Stroke (2023) now support the need for referral for ongoing rehabilitation at any time point after a stroke if new goals are identified. Other referrals to voluntary sector organisations for information, peer support or exercise groups can also be made if indicated. 5. It is unclear if and how GPs are involved in the study? What information will they receive on both the intervention and control subjects? RESPONSE: The GPs will be informed via letter if one of their patients is involved in this study. They will be informed if the person is in the intervention or control group and will be provided with information on the purpose of the study and what it involves. Contact details of the researcher will also be available on the letter. Following the 1st and 2nd follow-up appointments the GP will receive a summary letter with the topics discussed and action plan agreed. To be included in the materials and procedures section: The participant's GP will be informed of their involvement in the study and which group they have been randomised to. A brief description of the purpose of the study and what it involves, as well as the research team’s contact details, will be included in the letter sent to the GP. Appointment 1: Written summary sent to GP with topics discussed and action plan agreed. Appointment 2: Written summary and plan to be sent to GP with topics discussed and action plan agreed. 6. There is also some concern that retention rates will be substantially lower for the control group given that they receive little (or no?) direct contact after enrollment. Investigators should consider adding some minimal ongoing level of engagement with the control group between 2 and 6 weeks. RESPONSE: The ongoing engagement with the control group will be the provision of the mobile number and email address of the researcher. Participants will be informed that they can contact the researcher at any time during the 12-week duration of the study if they have questions arising related to their stroke or its effects. Under normal circumstances it is not possible to have contact with the acute team once a person has left the hospital. All concerns need to be directed to the GP, but GPs may not have received the hospital discharge summary and because the IT systems are not linked they are unable to see what upcoming investigations and appointments have been booked. Having direct access to a professional based in the acute setting is therefore advantageous and offers the opportunity for an ongoing level of engagement. Adjustments made in response to question 2 also provide information on how this will provide an ongoing level of engagement. Control group The participants in the control group will receive standard care. This involves the provision of a printed information sheet on therapy services that exist in their locality and referral to the Stroke Association Connect service, which makes telephone contact with the person after discharge. A six-month stroke review referral is also sent, but currently, this is not consistently provided across all localities. In addition to standard care, those in the control group will be provided with a mobile telephone number and email address for the lead researcher to enable easy contact during the 12-week duration of the study if questions arise relating to their stroke or its effects. If referrals onto community stroke therapy services are indicated at the 12-week outcome measurement appointment, then they will be made at that time. 7. Clarify if the Stroke Association Connect program will be given to both arms? And whether the program itself has been made aware of this trial and the subject’s enrolment? RESPONSE: Both arms are referred to the Stroke Association Connect programme. This programme involves a follow-up telephone call to the person after stroke between 2-4 weeks after the event. The Stroke Association connector provides reassurance, guidance with any immediate concerns, and connects people to ongoing peer support. The connector is not medically trained, and they are not provided with any of the persons medical details except that they have had a stroke. If any medical questions arise the person is directed to speak to their GP. This is part of usual care, and the connector will not routinely be informed of the participants' involvement in the study. The intervention is composed of two follow-up appointments and telephone access to the researcher to address questions that may arise between appointments. Participants in this group will receive referral to the Stroke Association Connect Service and six-month stroke review referrals as part of standard care. Follow-up appointments will occur at 2 and 6 weeks after recruitment and will last from 30 to 60 min, depending on the need. 8. I would suggest that a patient-reported measure of physical function be collected at baseline, 2, 6 and 12 weeks, and also that all baseline data collection is standardized to occur at the same time point (preferably soon after returning home). RESPONSE: Thank you for this suggestion. We are using the PROMIS10 Global Health patient-reported measure, and this will give a physical health and mental health score at 2 weeks and 12 weeks. This measure is not being used at baseline because participants will largely be recruited within one or two days of their stroke and therefore may not yet have a sense of how their physical function and mental health has been impacted. The modified Rankin Scale is being gathered to give an indication of pre-stroke physical function. As you have highlighted it is important to standardize the timepoint at which the baseline data is collected, we have now included this in the manuscript text. As this is a feasibility study, we are providing a 1 week window from diagnosis to baseline assessment (either in hospital or a few days after getting home). This will enable us to understand participant preference and through qualitative interviews explore the participants' perspective on having the baseline assessments at home versus when still in hospital. Outcome measurement: Baseline measures for both groups will be conducted by the OT researcher in the hospital where possible, but if the person is discharged quickly or seen in the RAC, then they will be conducted at the persons home or in the clinic. Baseline assessment will be conducted within 1 week of the stroke. The location of the final outcome measurement will be agreed upon with the participant and could be in their home or in the hospital. 9. It is unclear why the outcome assessment is not being done blinded? Explain and justify. What mitigation steps can be taken to reduce bias? RESPONSE: Thank you, this is an important point. As this feasibility study is part of a PhD, there is only funding available for one researcher and therefore all measurement and delivery of the intervention is being conducted by the same person. If the results suggest that a future funded definitive trial is possible then outcome assessment will be blinded as there will be a team involved in delivering the study. In this feasibility study the focus is on the feasibility objectives of recruitment, adherence and retention rather than any efficacy measures. However, in acknowledgement of the reviewer's point we have now included in the manuscript an acknowledgement that an unblinded outcome assessor can introduce bias. The responsiveness of the outcome measures to change will be reviewed using confidence intervals for changes from baseline in each group and for between-group comparisons of changes. The numerical results and perceived relevance of the outcome measures used in this feasibility study will be considered. It should be noted that for the current feasibility study the outcome assessor is not blinded, and this has the potential to introduce bias in the assessment. The plan for a future definitive trial would involve a blinded outcome assessor. 10. Eligibility criteria does not include a baseline NIHSS score? Why is this? What is the maximum time allowed between stroke onset and enrolment? RESPONSE: Thank you for highlighting this and this is an omission on our part. We have now added this to the inclusion criteria: NIHSS ≤ 5 at 2 hours post admission to allow those that have had hyperacute interventions and done well to be included in the study. We have also now clarified in the inclusion criteria the maximum time allowed between stroke onset and enrolment. Eligibility criteria Inclusion criteria • Adult ≥18 • Clinical or radiological diagnosis of minor stroke from a stroke consultant. • Admitted to HASU or seen in RAC. • Pre-admission modified Rankin Score (mRS) of 0-3 (see table below), with no formal package of care prior to stroke. Table 1. Modified Rankin Scale scores- NIHSS ≤ 5 at 2 hours post admission - Within one week of receiving stroke diagnosis • No onward referral to community therapy team or for package of care. • Has capacity to consent. 11.What is the expected total annual stroke case load at the RAC and HASU? RESPONSE: Our hyperacute stroke unit (HASU) has approximately 1700 admissions per year, about 1400 of which end up with a diagnosis of stroke. The Rapid Assessment Clinic receives about 160 – 175 referrals every month, of which 50 – 60 are rejected. Many of the referrals are stroke mimics, some are TIA and about 5 per month receive a diagnosis of minor stroke. 12. Table 3: The >90% recruitment threshold appears to be quite ambitious and may be difficult to reach. RESPONSE: Thank you for this comment and you are correct that it is an ambitious target. We believe that this target for this feasibility study may be achievable for the following reasons: - It is only conducted at a single centre and the researcher has good working relationships with both the stroke medical and therapy teams. - We have done extensive outreach work with diverse community groups which has improved our understanding of culturally appropriate ways to approach patients from different communities. We believe that this may result in more successful recruitment of participants that reflect the stroke demographic. - The personalised nature of the intervention and flexible follow-up appointment arrangements were designed to cause minimum disruption to a person’s daily life, caring responsibilities and work routines. The targets may seem ambitious, but due to the limited number of appointments and personalised nature of the intervention, where participants do not need to attend appointments at the hospital, we believe these are achievable. We have carried out extensive work with diverse community groups that has improved our understanding of culturally appropriate ways to approach patients from different communities. Further, this is also a single-centre study, with the lead researcher having established working relationships with the other members of the stroke team. 13. Table 4. Add fatigue? RESPONSE: As you highlight through this suggestion, fatigue is a commonly reported problem after minor stroke. In order to keep the burden of outcome measure completion as low as possible for the feasibility study we decided that rather than include an additional separate fatigue outcome measure, we would utilise the fatigue question included in the PROMIS-10 v1.2 ('In the past 7 days how would you rate your fatigue on average?') In any future definitive trial, we would include a measure of fatigue that provides more granularity rather than solely determining whether it is present. 14. The success or failure of studies like this largely depends on how treatment efficacy is measured. Decision on how a primary outcome measure will be selected are far from easy. More details of how qualitative interviews and data responsiveness will be combined to make the choice is required. RESPONSE: This will be one of the most important and challenging questions to answer when moving from the current feasibility study to a definitive trial. Thus, a stated secondary objective in this feasibility study is to determine what outcome measures should be used for a future efficacy trial. We will be looking at a number of factors:- Accessibility: are participants able to understand and complete the outcome measures without support? When extra support is required does this relate to language or understanding of concepts or something different to these. - Responsiveness to change: we will review the quantitative outcome measures to understand if they reflect any change within and between groups over the duration of the study. - Qualitative interviews: we will look at how the scores on patient reported outcome measures align with what people report in the qualitative interviews. We will need to explore whether the themes that arise from the qualitative data are captured in the quantitative measures used. - Below we provide a more detailed description of how we propose to select a primary outcome measure. Qualitative data analysis Participants in the control and intervention groups will be invited to participate in qualitative, semi-structured interviews. The focus of this will be to explore and understand the experience of receiving a diagnosis of stroke and life after stroke for those who received the intervention and those who did not. We will seek to understand whether the intervention delivered was acceptable and how it could be improved. Alongside this we will review the quantitative measures alongside subjective reports from participants to evaluate whether there is alignment of the qualitative perspectives and quantitative results. The planned purposive sampling strategy will enable the researcher to interview those who seemed to cope well with the transition back to their lives as well as those that appear to be having more adjustment difficulties. This will capture a diversity of experiences and perspectives. We will explore whether the themes that arise from the qualitative data are captured in the quantitative measures used. Key concepts and themes that are prominent in the qualitative data will help the researcher to understand what matters to the participants. This also creates an opportunity for participants to introduce topics that may not be reflected in the outcome measures used in the feasibility study. Through these processes we aim to increase the likelihood of identifying a primary outcome for a subsequent definitive trial that is sufficiently nuanced to capture efficacy in a socio-culturally diverse population. 15. What are the hypothesized mechanisms where 2 visits focused on unmet needs can really make a difference? RESPONSE: We agree with the reviewer that the manuscript would be improved with more extensive mechanistic underpinning of the detailed intervention. Below we describe what the proposed mechanisms of action are that underpin how two follow-up appointments might achieve improved knowledge, health and wellbeing. We will add this text to the manuscript after the descriptions of the intervention and tailoring. The hypothesized mechanisms for action are underpinned by self-determination theory (3). This theory posits that we all have three basic psychological needs for competence, autonomy and relatedness and when these are supported a person’s motivation and engagement are improved. The proposed mechanisms of action within the intervention are: 1) Enhanced, personalised communication – this requires listening to and understanding the participants priorities and needs. It requires an understanding of a person’s health literacy and education level. Communication is personalised and adjusted according to the individual’s needs, acknowledging that one approach would not meet everyone’s needs. 2) Partnership working – this approach changes the power dynamic in healthcare interactions and moves away from traditional hierarchical, paternalistic approaches and facilitates the pursuit of personalised goals. It involves linking the participant in with, or referring them on to, other support services in the community. This approach helps to address adjustment to life after stroke and can mitigate against feelings of isolation and abandonment. It aims to support a sense of belonging, feeling cared for and connected with others. 3) Enablement – by focusing on communication and partnership-working a participant is supported to have freedom of choice to engage in actions that are congruent with their values and priorities. They are given the tools and knowledge to influence the outcomes that are important to them. This supports intrinsic motivation to initiate and sustain behaviour that supports health and wellbeing. 1. Willeit P, Toell T, Boehme C, Krebs S, Mayer L, Lang C, et al. STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial. EClinicalMedicine. 2020;25:100476. 2. Fu V, Weatherall M, McPherson K, Taylor W, McRae A, Thomson T, et al. Taking Charge after Stroke: A randomized controlled trial of a person-centered, self-directed rehabilitation intervention. Int J Stroke. 2020:1747493020915144. 3. Ryan R DE. Self-Determination Theory and the Facilitation of Intrinsic Motivation, Social Development, and Well-Being. Am Psychol. 2000;55(1):68-78. COMMENTS ON THIS REPORT - Author Response 25 Nov 2024Jennifer Crow, Department of Occupational Therapy and Physiotherapy, Imperial College Healthcare NHS Trust, London, UK25 Nov 2024Author ResponseDear Professor Reeves Thank you for taking the time to review our feasibility study protocol and for the helpful feedback and suggestions you have provided. We have responded to all ... Continue reading Dear Professor Reeves Thank you for taking the time to review our feasibility study protocol and for the helpful feedback and suggestions you have provided. We have responded to all the points you have raised and have made adjustments to our protocol manuscript accordingly to improve the quality, clarity and robustness of the feasibility study being conducted. See below our point-by-point responses to your comments with our responses labelled as 'response' and manuscript adjustments underlined within the original text, both in italics. 1.One thing that could have been given more attention is that few if any interventions to date have shown meaningful improvements in patient outcomes in this population. RESPONSE: Thank you, this is a very important question to address. We have now added an explanation to the manuscript text to provide more clarity on how the scoping review helped us to identify potential key elements for inclusion in our intervention. Specifically, we describe two studies that were able to demonstrate meaningful improvement in HRQOL at 12 months after stroke. In our intervention the key elements that we have included are a multidisciplinary focus, personalised care and self-determination theory. We conducted a scoping review to identify follow-up programmes, pathways, and services that have been developed for people after minor stroke22. Twenty-five studies were included in the analysis. Interventions often focused on education, secondary prevention, and exercise after stroke, whereas the management of hidden impairments and adjustment to life after stroke were less likely to be addressed. These complex interventions were often poorly described, and descriptions of family involvement, liaison between primary and secondary care, and underpinning psychological or behavioural theories were lacking. The review revealed that it is still unknown how best to organise services to offer personalised timely support and education to people in the community. There were two RCTs included in the scoping review (STROKECARD(1) and the Taking Charge after Stroke (TACAS) study(2)) that were able to demonstrate improvements in health-related quality of life at 12 months after the stroke. STROKECARD involved personalised, comprehensive multidisciplinary follow-up at 3 months post stroke and the TACAS follow-up intervention was underpinned by self-determination theory and involved either one or two follow-up appointments. TACAS’s person centred intervention focused on supporting a person to take charge of their recovery through supporting self-empowerment. The key elements from these two studies; multidisciplinary focus, personalised care and self-determination theory are included in the intervention described in this protocol. We believe that this may increase the likelihood of being able to show meaningful improvements in this diverse patient population. 2. Two touch points at 2 and 6 weeks is quite limited. Opportunities to continue the dialogue and delivery of services across the 12-week period are probably needed. RESPONSE: Thank you for this point. The two follow-up appointments are supplemented by direct mobile phone access to the researcher which enables participants to discuss any questions or concerns that arise during the 12-week duration of the study. The researcher in turn has direct access to the clinical team, including the stroke clinical specialist nurses if medical concerns are raised. This is novel because currently it is very difficult to have any ad hoc contact with the stroke clinical team after discharge. Contact is restricted to the follow-up medical appointment which could be 12 weeks after discharge. Due to substantial pressures within primary care, GPs are currently very difficult to access directly, and they often direct questions back to the specialist stroke service. I have provided further clarification of this in the manuscript text as below. The intervention is composed of two follow-up appointments and telephone access to the researcher to address questions that may arise between appointments. The researcher has direct access to the clinical team and stroke clinical specialist nurses if medical concerns are raised. This may help to address feelings of abandonment that are frequently described in the literature. Currently it is very difficult to have ad hoc contact with the stroke clinical team after discharge. The fomal follow-up appointments will occur at 2 and 6 weeks after recruitment and will last from 30 to 60 min, depending on the identified needs. 3. There appears to be limited use of mHealth technologies to deliver or supplement the intervention, or to collect data. RESPONSE: Thank you for raising this important question. We recognise the increasing relevance of these approaches, but in order to be inclusive and avoid digital exclusion we have limited the essential use of mHealth technologies in the intervention delivery and outcome measurement. The option does exist for the follow-up appointments to be conducted virtually as well as the outcome measurement at 12 weeks. In these cases, the participants will be sent electronic versions of the patient reported outcome measures. We will not be excluding the use of online resources and digital Apps but will only signpost participants to them when they are familiar with, and have easy access to, these technologies. In this way we hope to provide accessible and personally tailored follow-up. Below we have tried to make this clearer in the manuscript. To ensure the delivery of a personalised intervention, follow-up appointments will be offered face-to-face in person at the hospital, participant’s home, or a neutral venue in the community, or as a telephone or video call/virtual appointment. Participants will have the option of completing their twelve-week outcome measurement in person or alternatively electronic versions of the outcome measures will be sent to participants for their completion. The preferred modality will be noted and will inform a future definitive trial. Where signposting to online information resources or digital Apps is indicated this will form part of the intervention. This will however only be utilized with those that are familiar with and have easy access to these technologies. 4. It would be helpful if specific examples of community-based referrals that are available to be accessed within the time period of the intervention were identified. RESPONSE: We have now clarified this in the manuscript text as below, in the ‘How, when and where’ section of the text which describes what is covered in the follow-up appointments. A GP could potentially also make these referrals but given that a GP appointment in the UK is 9 minutes long it is unlikely that they will have the opportunity to gauge what a person’s post-stroke functional, cognitive or psychological problems might be and they will therefore be unlikely to initiate referrals for ongoing community stroke therapy. Examples of onward community-based referrals that may be indicated include referral to the community stroke therapy team. This may be indicated when the person is back at home and engaging in their everyday activities and then becomes aware of higher-level difficulties that were not detected initially. The hidden impacts of stroke such as fatigue and mood issues are also more likely to become apparent after a period of time at home. Within the UK and Ireland the National Clinical Guidelines for Stroke (2023) now support the need for referral for ongoing rehabilitation at any time point after a stroke if new goals are identified. Other referrals to voluntary sector organisations for information, peer support or exercise groups can also be made if indicated. 5. It is unclear if and how GPs are involved in the study? What information will they receive on both the intervention and control subjects? RESPONSE: The GPs will be informed via letter if one of their patients is involved in this study. They will be informed if the person is in the intervention or control group and will be provided with information on the purpose of the study and what it involves. Contact details of the researcher will also be available on the letter. Following the 1st and 2nd follow-up appointments the GP will receive a summary letter with the topics discussed and action plan agreed. To be included in the materials and procedures section: The participant's GP will be informed of their involvement in the study and which group they have been randomised to. A brief description of the purpose of the study and what it involves, as well as the research team’s contact details, will be included in the letter sent to the GP. Appointment 1: Written summary sent to GP with topics discussed and action plan agreed. Appointment 2: Written summary and plan to be sent to GP with topics discussed and action plan agreed. 6. There is also some concern that retention rates will be substantially lower for the control group given that they receive little (or no?) direct contact after enrollment. Investigators should consider adding some minimal ongoing level of engagement with the control group between 2 and 6 weeks. RESPONSE: The ongoing engagement with the control group will be the provision of the mobile number and email address of the researcher. Participants will be informed that they can contact the researcher at any time during the 12-week duration of the study if they have questions arising related to their stroke or its effects. Under normal circumstances it is not possible to have contact with the acute team once a person has left the hospital. All concerns need to be directed to the GP, but GPs may not have received the hospital discharge summary and because the IT systems are not linked they are unable to see what upcoming investigations and appointments have been booked. Having direct access to a professional based in the acute setting is therefore advantageous and offers the opportunity for an ongoing level of engagement. Adjustments made in response to question 2 also provide information on how this will provide an ongoing level of engagement. Control group The participants in the control group will receive standard care. This involves the provision of a printed information sheet on therapy services that exist in their locality and referral to the Stroke Association Connect service, which makes telephone contact with the person after discharge. A six-month stroke review referral is also sent, but currently, this is not consistently provided across all localities. In addition to standard care, those in the control group will be provided with a mobile telephone number and email address for the lead researcher to enable easy contact during the 12-week duration of the study if questions arise relating to their stroke or its effects. If referrals onto community stroke therapy services are indicated at the 12-week outcome measurement appointment, then they will be made at that time. 7. Clarify if the Stroke Association Connect program will be given to both arms? And whether the program itself has been made aware of this trial and the subject’s enrolment? RESPONSE: Both arms are referred to the Stroke Association Connect programme. This programme involves a follow-up telephone call to the person after stroke between 2-4 weeks after the event. The Stroke Association connector provides reassurance, guidance with any immediate concerns, and connects people to ongoing peer support. The connector is not medically trained, and they are not provided with any of the persons medical details except that they have had a stroke. If any medical questions arise the person is directed to speak to their GP. This is part of usual care, and the connector will not routinely be informed of the participants' involvement in the study. The intervention is composed of two follow-up appointments and telephone access to the researcher to address questions that may arise between appointments. Participants in this group will receive referral to the Stroke Association Connect Service and six-month stroke review referrals as part of standard care. Follow-up appointments will occur at 2 and 6 weeks after recruitment and will last from 30 to 60 min, depending on the need. 8. I would suggest that a patient-reported measure of physical function be collected at baseline, 2, 6 and 12 weeks, and also that all baseline data collection is standardized to occur at the same time point (preferably soon after returning home). RESPONSE: Thank you for this suggestion. We are using the PROMIS10 Global Health patient-reported measure, and this will give a physical health and mental health score at 2 weeks and 12 weeks. This measure is not being used at baseline because participants will largely be recruited within one or two days of their stroke and therefore may not yet have a sense of how their physical function and mental health has been impacted. The modified Rankin Scale is being gathered to give an indication of pre-stroke physical function. As you have highlighted it is important to standardize the timepoint at which the baseline data is collected, we have now included this in the manuscript text. As this is a feasibility study, we are providing a 1 week window from diagnosis to baseline assessment (either in hospital or a few days after getting home). This will enable us to understand participant preference and through qualitative interviews explore the participants' perspective on having the baseline assessments at home versus when still in hospital. Outcome measurement: Baseline measures for both groups will be conducted by the OT researcher in the hospital where possible, but if the person is discharged quickly or seen in the RAC, then they will be conducted at the persons home or in the clinic. Baseline assessment will be conducted within 1 week of the stroke. The location of the final outcome measurement will be agreed upon with the participant and could be in their home or in the hospital. 9. It is unclear why the outcome assessment is not being done blinded? Explain and justify. What mitigation steps can be taken to reduce bias? RESPONSE: Thank you, this is an important point. As this feasibility study is part of a PhD, there is only funding available for one researcher and therefore all measurement and delivery of the intervention is being conducted by the same person. If the results suggest that a future funded definitive trial is possible then outcome assessment will be blinded as there will be a team involved in delivering the study. In this feasibility study the focus is on the feasibility objectives of recruitment, adherence and retention rather than any efficacy measures. However, in acknowledgement of the reviewer's point we have now included in the manuscript an acknowledgement that an unblinded outcome assessor can introduce bias. The responsiveness of the outcome measures to change will be reviewed using confidence intervals for changes from baseline in each group and for between-group comparisons of changes. The numerical results and perceived relevance of the outcome measures used in this feasibility study will be considered. It should be noted that for the current feasibility study the outcome assessor is not blinded, and this has the potential to introduce bias in the assessment. The plan for a future definitive trial would involve a blinded outcome assessor. 10. Eligibility criteria does not include a baseline NIHSS score? Why is this? What is the maximum time allowed between stroke onset and enrolment? RESPONSE: Thank you for highlighting this and this is an omission on our part. We have now added this to the inclusion criteria: NIHSS ≤ 5 at 2 hours post admission to allow those that have had hyperacute interventions and done well to be included in the study. We have also now clarified in the inclusion criteria the maximum time allowed between stroke onset and enrolment. Eligibility criteria Inclusion criteria • Adult ≥18 • Clinical or radiological diagnosis of minor stroke from a stroke consultant. • Admitted to HASU or seen in RAC. • Pre-admission modified Rankin Score (mRS) of 0-3 (see table below), with no formal package of care prior to stroke. Table 1. Modified Rankin Scale scores- NIHSS ≤ 5 at 2 hours post admission - Within one week of receiving stroke diagnosis • No onward referral to community therapy team or for package of care. • Has capacity to consent. 11.What is the expected total annual stroke case load at the RAC and HASU? RESPONSE: Our hyperacute stroke unit (HASU) has approximately 1700 admissions per year, about 1400 of which end up with a diagnosis of stroke. The Rapid Assessment Clinic receives about 160 – 175 referrals every month, of which 50 – 60 are rejected. Many of the referrals are stroke mimics, some are TIA and about 5 per month receive a diagnosis of minor stroke. 12. Table 3: The >90% recruitment threshold appears to be quite ambitious and may be difficult to reach. RESPONSE: Thank you for this comment and you are correct that it is an ambitious target. We believe that this target for this feasibility study may be achievable for the following reasons: - It is only conducted at a single centre and the researcher has good working relationships with both the stroke medical and therapy teams. - We have done extensive outreach work with diverse community groups which has improved our understanding of culturally appropriate ways to approach patients from different communities. We believe that this may result in more successful recruitment of participants that reflect the stroke demographic. - The personalised nature of the intervention and flexible follow-up appointment arrangements were designed to cause minimum disruption to a person’s daily life, caring responsibilities and work routines. The targets may seem ambitious, but due to the limited number of appointments and personalised nature of the intervention, where participants do not need to attend appointments at the hospital, we believe these are achievable. We have carried out extensive work with diverse community groups that has improved our understanding of culturally appropriate ways to approach patients from different communities. Further, this is also a single-centre study, with the lead researcher having established working relationships with the other members of the stroke team. 13. Table 4. Add fatigue? RESPONSE: As you highlight through this suggestion, fatigue is a commonly reported problem after minor stroke. In order to keep the burden of outcome measure completion as low as possible for the feasibility study we decided that rather than include an additional separate fatigue outcome measure, we would utilise the fatigue question included in the PROMIS-10 v1.2 ('In the past 7 days how would you rate your fatigue on average?') In any future definitive trial, we would include a measure of fatigue that provides more granularity rather than solely determining whether it is present. 14. The success or failure of studies like this largely depends on how treatment efficacy is measured. Decision on how a primary outcome measure will be selected are far from easy. More details of how qualitative interviews and data responsiveness will be combined to make the choice is required. RESPONSE: This will be one of the most important and challenging questions to answer when moving from the current feasibility study to a definitive trial. Thus, a stated secondary objective in this feasibility study is to determine what outcome measures should be used for a future efficacy trial. We will be looking at a number of factors:- Accessibility: are participants able to understand and complete the outcome measures without support? When extra support is required does this relate to language or understanding of concepts or something different to these. - Responsiveness to change: we will review the quantitative outcome measures to understand if they reflect any change within and between groups over the duration of the study. - Qualitative interviews: we will look at how the scores on patient reported outcome measures align with what people report in the qualitative interviews. We will need to explore whether the themes that arise from the qualitative data are captured in the quantitative measures used. - Below we provide a more detailed description of how we propose to select a primary outcome measure. Qualitative data analysis Participants in the control and intervention groups will be invited to participate in qualitative, semi-structured interviews. The focus of this will be to explore and understand the experience of receiving a diagnosis of stroke and life after stroke for those who received the intervention and those who did not. We will seek to understand whether the intervention delivered was acceptable and how it could be improved. Alongside this we will review the quantitative measures alongside subjective reports from participants to evaluate whether there is alignment of the qualitative perspectives and quantitative results. The planned purposive sampling strategy will enable the researcher to interview those who seemed to cope well with the transition back to their lives as well as those that appear to be having more adjustment difficulties. This will capture a diversity of experiences and perspectives. We will explore whether the themes that arise from the qualitative data are captured in the quantitative measures used. Key concepts and themes that are prominent in the qualitative data will help the researcher to understand what matters to the participants. This also creates an opportunity for participants to introduce topics that may not be reflected in the outcome measures used in the feasibility study. Through these processes we aim to increase the likelihood of identifying a primary outcome for a subsequent definitive trial that is sufficiently nuanced to capture efficacy in a socio-culturally diverse population. 15. What are the hypothesized mechanisms where 2 visits focused on unmet needs can really make a difference? RESPONSE: We agree with the reviewer that the manuscript would be improved with more extensive mechanistic underpinning of the detailed intervention. Below we describe what the proposed mechanisms of action are that underpin how two follow-up appointments might achieve improved knowledge, health and wellbeing. We will add this text to the manuscript after the descriptions of the intervention and tailoring. The hypothesized mechanisms for action are underpinned by self-determination theory (3). This theory posits that we all have three basic psychological needs for competence, autonomy and relatedness and when these are supported a person’s motivation and engagement are improved. The proposed mechanisms of action within the intervention are: 1) Enhanced, personalised communication – this requires listening to and understanding the participants priorities and needs. It requires an understanding of a person’s health literacy and education level. Communication is personalised and adjusted according to the individual’s needs, acknowledging that one approach would not meet everyone’s needs. 2) Partnership working – this approach changes the power dynamic in healthcare interactions and moves away from traditional hierarchical, paternalistic approaches and facilitates the pursuit of personalised goals. It involves linking the participant in with, or referring them on to, other support services in the community. This approach helps to address adjustment to life after stroke and can mitigate against feelings of isolation and abandonment. It aims to support a sense of belonging, feeling cared for and connected with others. 3) Enablement – by focusing on communication and partnership-working a participant is supported to have freedom of choice to engage in actions that are congruent with their values and priorities. They are given the tools and knowledge to influence the outcomes that are important to them. This supports intrinsic motivation to initiate and sustain behaviour that supports health and wellbeing. 1. Willeit P, Toell T, Boehme C, Krebs S, Mayer L, Lang C, et al. STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial. EClinicalMedicine. 2020;25:100476. 2. Fu V, Weatherall M, McPherson K, Taylor W, McRae A, Thomson T, et al. Taking Charge after Stroke: A randomized controlled trial of a person-centered, self-directed rehabilitation intervention. Int J Stroke. 2020:1747493020915144. 3. Ryan R DE. Self-Determination Theory and the Facilitation of Intrinsic Motivation, Social Development, and Well-Being. Am Psychol. 2000;55(1):68-78.Dear Professor ReevesCompeting Interests: No competing interests Close Thank you for taking the time to review our feasibility study protocol and for the helpful feedback and suggestions you have provided. We have responded to all the points you have raised and have made adjustments to our protocol manuscript accordingly to improve the quality, clarity and robustness of the feasibility study being conducted. See below our point-by-point responses to your comments with our responses labelled as 'response' and manuscript adjustments underlined within the original text, both in italics. 1.One thing that could have been given more attention is that few if any interventions to date have shown meaningful improvements in patient outcomes in this population. RESPONSE: Thank you, this is a very important question to address. We have now added an explanation to the manuscript text to provide more clarity on how the scoping review helped us to identify potential key elements for inclusion in our intervention. Specifically, we describe two studies that were able to demonstrate meaningful improvement in HRQOL at 12 months after stroke. In our intervention the key elements that we have included are a multidisciplinary focus, personalised care and self-determination theory. We conducted a scoping review to identify follow-up programmes, pathways, and services that have been developed for people after minor stroke22. Twenty-five studies were included in the analysis. Interventions often focused on education, secondary prevention, and exercise after stroke, whereas the management of hidden impairments and adjustment to life after stroke were less likely to be addressed. These complex interventions were often poorly described, and descriptions of family involvement, liaison between primary and secondary care, and underpinning psychological or behavioural theories were lacking. The review revealed that it is still unknown how best to organise services to offer personalised timely support and education to people in the community. There were two RCTs included in the scoping review (STROKECARD(1) and the Taking Charge after Stroke (TACAS) study(2)) that were able to demonstrate improvements in health-related quality of life at 12 months after the stroke. STROKECARD involved personalised, comprehensive multidisciplinary follow-up at 3 months post stroke and the TACAS follow-up intervention was underpinned by self-determination theory and involved either one or two follow-up appointments. TACAS’s person centred intervention focused on supporting a person to take charge of their recovery through supporting self-empowerment. The key elements from these two studies; multidisciplinary focus, personalised care and self-determination theory are included in the intervention described in this protocol. We believe that this may increase the likelihood of being able to show meaningful improvements in this diverse patient population. 2. Two touch points at 2 and 6 weeks is quite limited. Opportunities to continue the dialogue and delivery of services across the 12-week period are probably needed. RESPONSE: Thank you for this point. The two follow-up appointments are supplemented by direct mobile phone access to the researcher which enables participants to discuss any questions or concerns that arise during the 12-week duration of the study. The researcher in turn has direct access to the clinical team, including the stroke clinical specialist nurses if medical concerns are raised. This is novel because currently it is very difficult to have any ad hoc contact with the stroke clinical team after discharge. Contact is restricted to the follow-up medical appointment which could be 12 weeks after discharge. Due to substantial pressures within primary care, GPs are currently very difficult to access directly, and they often direct questions back to the specialist stroke service. I have provided further clarification of this in the manuscript text as below. The intervention is composed of two follow-up appointments and telephone access to the researcher to address questions that may arise between appointments. The researcher has direct access to the clinical team and stroke clinical specialist nurses if medical concerns are raised. This may help to address feelings of abandonment that are frequently described in the literature. Currently it is very difficult to have ad hoc contact with the stroke clinical team after discharge. The fomal follow-up appointments will occur at 2 and 6 weeks after recruitment and will last from 30 to 60 min, depending on the identified needs. 3. There appears to be limited use of mHealth technologies to deliver or supplement the intervention, or to collect data. RESPONSE: Thank you for raising this important question. We recognise the increasing relevance of these approaches, but in order to be inclusive and avoid digital exclusion we have limited the essential use of mHealth technologies in the intervention delivery and outcome measurement. The option does exist for the follow-up appointments to be conducted virtually as well as the outcome measurement at 12 weeks. In these cases, the participants will be sent electronic versions of the patient reported outcome measures. We will not be excluding the use of online resources and digital Apps but will only signpost participants to them when they are familiar with, and have easy access to, these technologies. In this way we hope to provide accessible and personally tailored follow-up. Below we have tried to make this clearer in the manuscript. To ensure the delivery of a personalised intervention, follow-up appointments will be offered face-to-face in person at the hospital, participant’s home, or a neutral venue in the community, or as a telephone or video call/virtual appointment. Participants will have the option of completing their twelve-week outcome measurement in person or alternatively electronic versions of the outcome measures will be sent to participants for their completion. The preferred modality will be noted and will inform a future definitive trial. Where signposting to online information resources or digital Apps is indicated this will form part of the intervention. This will however only be utilized with those that are familiar with and have easy access to these technologies. 4. It would be helpful if specific examples of community-based referrals that are available to be accessed within the time period of the intervention were identified. RESPONSE: We have now clarified this in the manuscript text as below, in the ‘How, when and where’ section of the text which describes what is covered in the follow-up appointments. A GP could potentially also make these referrals but given that a GP appointment in the UK is 9 minutes long it is unlikely that they will have the opportunity to gauge what a person’s post-stroke functional, cognitive or psychological problems might be and they will therefore be unlikely to initiate referrals for ongoing community stroke therapy. Examples of onward community-based referrals that may be indicated include referral to the community stroke therapy team. This may be indicated when the person is back at home and engaging in their everyday activities and then becomes aware of higher-level difficulties that were not detected initially. The hidden impacts of stroke such as fatigue and mood issues are also more likely to become apparent after a period of time at home. Within the UK and Ireland the National Clinical Guidelines for Stroke (2023) now support the need for referral for ongoing rehabilitation at any time point after a stroke if new goals are identified. Other referrals to voluntary sector organisations for information, peer support or exercise groups can also be made if indicated. 5. It is unclear if and how GPs are involved in the study? What information will they receive on both the intervention and control subjects? RESPONSE: The GPs will be informed via letter if one of their patients is involved in this study. They will be informed if the person is in the intervention or control group and will be provided with information on the purpose of the study and what it involves. Contact details of the researcher will also be available on the letter. Following the 1st and 2nd follow-up appointments the GP will receive a summary letter with the topics discussed and action plan agreed. To be included in the materials and procedures section: The participant's GP will be informed of their involvement in the study and which group they have been randomised to. A brief description of the purpose of the study and what it involves, as well as the research team’s contact details, will be included in the letter sent to the GP. Appointment 1: Written summary sent to GP with topics discussed and action plan agreed. Appointment 2: Written summary and plan to be sent to GP with topics discussed and action plan agreed. 6. There is also some concern that retention rates will be substantially lower for the control group given that they receive little (or no?) direct contact after enrollment. Investigators should consider adding some minimal ongoing level of engagement with the control group between 2 and 6 weeks. RESPONSE: The ongoing engagement with the control group will be the provision of the mobile number and email address of the researcher. Participants will be informed that they can contact the researcher at any time during the 12-week duration of the study if they have questions arising related to their stroke or its effects. Under normal circumstances it is not possible to have contact with the acute team once a person has left the hospital. All concerns need to be directed to the GP, but GPs may not have received the hospital discharge summary and because the IT systems are not linked they are unable to see what upcoming investigations and appointments have been booked. Having direct access to a professional based in the acute setting is therefore advantageous and offers the opportunity for an ongoing level of engagement. Adjustments made in response to question 2 also provide information on how this will provide an ongoing level of engagement. Control group The participants in the control group will receive standard care. This involves the provision of a printed information sheet on therapy services that exist in their locality and referral to the Stroke Association Connect service, which makes telephone contact with the person after discharge. A six-month stroke review referral is also sent, but currently, this is not consistently provided across all localities. In addition to standard care, those in the control group will be provided with a mobile telephone number and email address for the lead researcher to enable easy contact during the 12-week duration of the study if questions arise relating to their stroke or its effects. If referrals onto community stroke therapy services are indicated at the 12-week outcome measurement appointment, then they will be made at that time. 7. Clarify if the Stroke Association Connect program will be given to both arms? And whether the program itself has been made aware of this trial and the subject’s enrolment? RESPONSE: Both arms are referred to the Stroke Association Connect programme. This programme involves a follow-up telephone call to the person after stroke between 2-4 weeks after the event. The Stroke Association connector provides reassurance, guidance with any immediate concerns, and connects people to ongoing peer support. The connector is not medically trained, and they are not provided with any of the persons medical details except that they have had a stroke. If any medical questions arise the person is directed to speak to their GP. This is part of usual care, and the connector will not routinely be informed of the participants' involvement in the study. The intervention is composed of two follow-up appointments and telephone access to the researcher to address questions that may arise between appointments. Participants in this group will receive referral to the Stroke Association Connect Service and six-month stroke review referrals as part of standard care. Follow-up appointments will occur at 2 and 6 weeks after recruitment and will last from 30 to 60 min, depending on the need. 8. I would suggest that a patient-reported measure of physical function be collected at baseline, 2, 6 and 12 weeks, and also that all baseline data collection is standardized to occur at the same time point (preferably soon after returning home). RESPONSE: Thank you for this suggestion. We are using the PROMIS10 Global Health patient-reported measure, and this will give a physical health and mental health score at 2 weeks and 12 weeks. This measure is not being used at baseline because participants will largely be recruited within one or two days of their stroke and therefore may not yet have a sense of how their physical function and mental health has been impacted. The modified Rankin Scale is being gathered to give an indication of pre-stroke physical function. As you have highlighted it is important to standardize the timepoint at which the baseline data is collected, we have now included this in the manuscript text. As this is a feasibility study, we are providing a 1 week window from diagnosis to baseline assessment (either in hospital or a few days after getting home). This will enable us to understand participant preference and through qualitative interviews explore the participants' perspective on having the baseline assessments at home versus when still in hospital. Outcome measurement: Baseline measures for both groups will be conducted by the OT researcher in the hospital where possible, but if the person is discharged quickly or seen in the RAC, then they will be conducted at the persons home or in the clinic. Baseline assessment will be conducted within 1 week of the stroke. The location of the final outcome measurement will be agreed upon with the participant and could be in their home or in the hospital. 9. It is unclear why the outcome assessment is not being done blinded? Explain and justify. What mitigation steps can be taken to reduce bias? RESPONSE: Thank you, this is an important point. As this feasibility study is part of a PhD, there is only funding available for one researcher and therefore all measurement and delivery of the intervention is being conducted by the same person. If the results suggest that a future funded definitive trial is possible then outcome assessment will be blinded as there will be a team involved in delivering the study. In this feasibility study the focus is on the feasibility objectives of recruitment, adherence and retention rather than any efficacy measures. However, in acknowledgement of the reviewer's point we have now included in the manuscript an acknowledgement that an unblinded outcome assessor can introduce bias. The responsiveness of the outcome measures to change will be reviewed using confidence intervals for changes from baseline in each group and for between-group comparisons of changes. The numerical results and perceived relevance of the outcome measures used in this feasibility study will be considered. It should be noted that for the current feasibility study the outcome assessor is not blinded, and this has the potential to introduce bias in the assessment. The plan for a future definitive trial would involve a blinded outcome assessor. 10. Eligibility criteria does not include a baseline NIHSS score? Why is this? What is the maximum time allowed between stroke onset and enrolment? RESPONSE: Thank you for highlighting this and this is an omission on our part. We have now added this to the inclusion criteria: NIHSS ≤ 5 at 2 hours post admission to allow those that have had hyperacute interventions and done well to be included in the study. We have also now clarified in the inclusion criteria the maximum time allowed between stroke onset and enrolment. Eligibility criteria Inclusion criteria • Adult ≥18 • Clinical or radiological diagnosis of minor stroke from a stroke consultant. • Admitted to HASU or seen in RAC. • Pre-admission modified Rankin Score (mRS) of 0-3 (see table below), with no formal package of care prior to stroke. Table 1. Modified Rankin Scale scores- NIHSS ≤ 5 at 2 hours post admission - Within one week of receiving stroke diagnosis • No onward referral to community therapy team or for package of care. • Has capacity to consent. 11.What is the expected total annual stroke case load at the RAC and HASU? RESPONSE: Our hyperacute stroke unit (HASU) has approximately 1700 admissions per year, about 1400 of which end up with a diagnosis of stroke. The Rapid Assessment Clinic receives about 160 – 175 referrals every month, of which 50 – 60 are rejected. Many of the referrals are stroke mimics, some are TIA and about 5 per month receive a diagnosis of minor stroke. 12. Table 3: The >90% recruitment threshold appears to be quite ambitious and may be difficult to reach. RESPONSE: Thank you for this comment and you are correct that it is an ambitious target. We believe that this target for this feasibility study may be achievable for the following reasons: - It is only conducted at a single centre and the researcher has good working relationships with both the stroke medical and therapy teams. - We have done extensive outreach work with diverse community groups which has improved our understanding of culturally appropriate ways to approach patients from different communities. We believe that this may result in more successful recruitment of participants that reflect the stroke demographic. - The personalised nature of the intervention and flexible follow-up appointment arrangements were designed to cause minimum disruption to a person’s daily life, caring responsibilities and work routines. The targets may seem ambitious, but due to the limited number of appointments and personalised nature of the intervention, where participants do not need to attend appointments at the hospital, we believe these are achievable. We have carried out extensive work with diverse community groups that has improved our understanding of culturally appropriate ways to approach patients from different communities. Further, this is also a single-centre study, with the lead researcher having established working relationships with the other members of the stroke team. 13. Table 4. Add fatigue? RESPONSE: As you highlight through this suggestion, fatigue is a commonly reported problem after minor stroke. In order to keep the burden of outcome measure completion as low as possible for the feasibility study we decided that rather than include an additional separate fatigue outcome measure, we would utilise the fatigue question included in the PROMIS-10 v1.2 ('In the past 7 days how would you rate your fatigue on average?') In any future definitive trial, we would include a measure of fatigue that provides more granularity rather than solely determining whether it is present. 14. The success or failure of studies like this largely depends on how treatment efficacy is measured. Decision on how a primary outcome measure will be selected are far from easy. More details of how qualitative interviews and data responsiveness will be combined to make the choice is required. RESPONSE: This will be one of the most important and challenging questions to answer when moving from the current feasibility study to a definitive trial. Thus, a stated secondary objective in this feasibility study is to determine what outcome measures should be used for a future efficacy trial. We will be looking at a number of factors:- Accessibility: are participants able to understand and complete the outcome measures without support? When extra support is required does this relate to language or understanding of concepts or something different to these. - Responsiveness to change: we will review the quantitative outcome measures to understand if they reflect any change within and between groups over the duration of the study. - Qualitative interviews: we will look at how the scores on patient reported outcome measures align with what people report in the qualitative interviews. We will need to explore whether the themes that arise from the qualitative data are captured in the quantitative measures used. - Below we provide a more detailed description of how we propose to select a primary outcome measure. Qualitative data analysis Participants in the control and intervention groups will be invited to participate in qualitative, semi-structured interviews. The focus of this will be to explore and understand the experience of receiving a diagnosis of stroke and life after stroke for those who received the intervention and those who did not. We will seek to understand whether the intervention delivered was acceptable and how it could be improved. Alongside this we will review the quantitative measures alongside subjective reports from participants to evaluate whether there is alignment of the qualitative perspectives and quantitative results. The planned purposive sampling strategy will enable the researcher to interview those who seemed to cope well with the transition back to their lives as well as those that appear to be having more adjustment difficulties. This will capture a diversity of experiences and perspectives. We will explore whether the themes that arise from the qualitative data are captured in the quantitative measures used. Key concepts and themes that are prominent in the qualitative data will help the researcher to understand what matters to the participants. This also creates an opportunity for participants to introduce topics that may not be reflected in the outcome measures used in the feasibility study. Through these processes we aim to increase the likelihood of identifying a primary outcome for a subsequent definitive trial that is sufficiently nuanced to capture efficacy in a socio-culturally diverse population. 15. What are the hypothesized mechanisms where 2 visits focused on unmet needs can really make a difference? RESPONSE: We agree with the reviewer that the manuscript would be improved with more extensive mechanistic underpinning of the detailed intervention. Below we describe what the proposed mechanisms of action are that underpin how two follow-up appointments might achieve improved knowledge, health and wellbeing. We will add this text to the manuscript after the descriptions of the intervention and tailoring. The hypothesized mechanisms for action are underpinned by self-determination theory (3). This theory posits that we all have three basic psychological needs for competence, autonomy and relatedness and when these are supported a person’s motivation and engagement are improved. The proposed mechanisms of action within the intervention are: 1) Enhanced, personalised communication – this requires listening to and understanding the participants priorities and needs. It requires an understanding of a person’s health literacy and education level. Communication is personalised and adjusted according to the individual’s needs, acknowledging that one approach would not meet everyone’s needs. 2) Partnership working – this approach changes the power dynamic in healthcare interactions and moves away from traditional hierarchical, paternalistic approaches and facilitates the pursuit of personalised goals. It involves linking the participant in with, or referring them on to, other support services in the community. This approach helps to address adjustment to life after stroke and can mitigate against feelings of isolation and abandonment. It aims to support a sense of belonging, feeling cared for and connected with others. 3) Enablement – by focusing on communication and partnership-working a participant is supported to have freedom of choice to engage in actions that are congruent with their values and priorities. They are given the tools and knowledge to influence the outcomes that are important to them. This supports intrinsic motivation to initiate and sustain behaviour that supports health and wellbeing. 1. Willeit P, Toell T, Boehme C, Krebs S, Mayer L, Lang C, et al. STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial. EClinicalMedicine. 2020;25:100476. 2. Fu V, Weatherall M, McPherson K, Taylor W, McRae A, Thomson T, et al. Taking Charge after Stroke: A randomized controlled trial of a person-centered, self-directed rehabilitation intervention. Int J Stroke. 2020:1747493020915144. 3. Ryan R DE. Self-Determination Theory and the Facilitation of Intrinsic Motivation, Social Development, and Well-Being. Am Psychol. 2000;55(1):68-78. Alongside their report, reviewers assign a status to the article: - Approved - Approved with reservations - Not approved | Invited Reviewers | || |---|---|---| | 1 | 2 | | | Version 3 (revision) 26 Feb 25 | read | | | Version 2 (revision) 25 Nov 24 | read | read | | Version 1 01 Aug 24 | read | Sign up for content alerts You are now signed up to receive this alert Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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