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Case...\", \"datePublished\": \"2025-04-24T10:57:54\", \"dateModified\": \"2025-04-24T10:57:54\", \"author\": [ { \"@type\": \"Person\", \"name\": \"Ruth McCullagh\" }, { \"@type\": \"Person\", \"name\": \"N.Frances Horgan\" }, { \"@type\": \"Person\", \"name\": \"Caroline Eldridge\" }, { \"@type\": \"Person\", \"name\": \"Katherine Thackeray\" }, { \"@type\": \"Person\", \"name\": \"Eibhlis Cahalane\" }, { \"@type\": \"Person\", \"name\": \"Vanda Cummins\" }, { \"@type\": \"Person\", \"name\": \"Edel Brennan\" }, { \"@type\": \"Person\", \"name\": \"Leanne Ahern\" }, { \"@type\": \"Person\", \"name\": \"Brendan Palmer\" }, { \"@type\": \"Person\", \"name\": \"Tony Foley\" }, { \"@type\": \"Person\", \"name\": \"Sheena McHugh\" }, { \"@type\": \"Person\", \"name\": \"Aileen Murphy\" }, { \"@type\": \"Person\", \"name\": \"Annlisa Setti\" }, { \"@type\": \"Person\", \"name\": \"Emmy Racine\" }, { \"@type\": \"Person\", \"name\": \"Éidín Ní Shé\" }, { \"@type\": \"Person\", \"name\": \"Dawn Skelton\" } ], \"publisher\": { \"@type\": \"Organization\", \"name\": \"HRB Open Research\", \"logo\": { \"@type\": \"ImageObject\", \"url\": \"https://hrbopenresearch.org/img/AMP/HRB_image.png\", \"height\": 566, \"width\": 60 } }, \"image\": { \"@type\": \"ImageObject\", \"url\": \"https://hrbopenresearch.org/img/AMP/HRB_image.png\", \"height\": 1200, \"width\": 127 }, \"description\": \"Falls and fall-related injuries in older people are common, with negative effects on functional independence, social engagement and quality of life. The estimated cost of falls related injuries in Ireland, including primary, acute and social care costs, is projected to exceed &euro;2 billion by 2030. The COVID-19 pandemic led to an increase in frailty and falls. Falls Management Exercise Programme (FaME) is a 24-week community-based group and home exercise programme led by qualified Postural Stability Instructors. It has been shown to reduce falls, and improve physical activity levels, physical function and wellbeing. FaME was first introduced in Ireland in 2021, and there are 120 specialist instructors trained to deliver FaME. We want to find the best way to get FaME implemented cost effectively in Ireland. How can we best establish FaME, ensuring we reach everyone who may fall, deliver FaME effectively and appropriately, and support people to keep living their best life after the programme? Although much has been learned regarding implementation of FaME in the UK, it is important to consider the implementation of FaME in an Irish context, where systems and cultures are different. By learning from and working with the specialist instructors at the early adopter sites, using mapping, observation, gap analysis, surveys, interviews, focus groups and workshops throughout, aligning our evaluation to the AFFINITY Project logic model and the Health Services Executive Change Guide we will &lsquo;Define, (co-)Design, Deliver and Disseminate&rsquo; our findings based on equity and reach, efficiency, appropriateness and sustainability, suitable physical activity options after the programme, and cost analysis for different scenarios of delivery. Working closely with PPI, Knowledge Users and an International Expert Group, we will deliver a FaME Community of Practice with a fit for purpose FaME Toolkit, synthesising the learning for future implementation across Ireland.\" } { \"@context\": \"http://schema.org\", \"@type\": \"BreadcrumbList\", \"itemListElement\": [ { \"@type\": \"ListItem\", \"position\": \"1\", \"item\": { \"@id\": \"https://hrbopenresearch.org/\", \"name\": \"Home\" } }, { \"@type\": \"ListItem\", \"position\": \"2\", \"item\": { \"@id\": \"https://hrbopenresearch.org/browse/articles\", \"name\": \"Browse\" } }, { \"@type\": \"ListItem\", \"position\": \"3\", \"item\": { \"@id\": \"https://hrbopenresearch.org/articles/8-56\", \"name\": \"Falls Management Exercise programme: Improving reach, effectiveness,...\" } } ] } Home Browse Falls Management Exercise programme: Improving reach, effectiveness,... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article McCullagh R, Horgan NF, Eldridge C et al. Falls Management Exercise programme: Improving reach, effectiveness, value and sustainability in Ireland. Case studies for learning (acronym: FaME Ireland): protocol of an observational evaluation study [version 1; peer review: awaiting peer review] . HRB Open Res 2025, 8 :56 ( https://doi.org/10.12688/hrbopenres.14115.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Falls Management Exercise programme: Improving reach, effectiveness, value and sustainability in Ireland. Case studies for learning (acronym: FaME Ireland): protocol of an observational evaluation study [version 1; peer review: awaiting peer review] Ruth McCullagh https://orcid.org/0000-0002-6489-183X 1 , N.Frances Horgan https://orcid.org/0000-0002-8773-9953 2 , Caroline Eldridge 1 , [...] Katherine Thackeray 1 , Eibhlis Cahalane 3 , Vanda Cummins 3 , Edel Brennan 3 , Leanne Ahern 1 , Brendan Palmer 4 , Tony Foley https://orcid.org/0000-0003-3205-3871 5 , Sheena McHugh https://orcid.org/0000-0002-6595-0491 4 , Aileen Murphy https://orcid.org/0000-0003-3062-0692 6 , Annlisa Setti 7 , Emmy Racine https://orcid.org/0000-0002-2247-8369 8 , Éidín Ní Shé 9 , Dawn Skelton https://orcid.org/0000-0001-6223-9840 10 Ruth McCullagh https://orcid.org/0000-0002-6489-183X 1 , N.Frances Horgan https://orcid.org/0000-0002-8773-9953 2 , [...] Caroline Eldridge 1 , Katherine Thackeray 1 , Eibhlis Cahalane 3 , Vanda Cummins 3 , Edel Brennan 3 , Leanne Ahern 1 , Brendan Palmer 4 , Tony Foley https://orcid.org/0000-0003-3205-3871 5 , Sheena McHugh https://orcid.org/0000-0002-6595-0491 4 , Aileen Murphy https://orcid.org/0000-0003-3062-0692 6 , Annlisa Setti 7 , Emmy Racine https://orcid.org/0000-0002-2247-8369 8 , Éidín Ní Shé 9 , Dawn Skelton https://orcid.org/0000-0001-6223-9840 10 PUBLISHED 24 Apr 2025 Author details Author details 1 Discipline of Physiotherapy, University College Cork School of Clinical Therapies, Cork, Ireland, T12 X70A, Ireland 2 School of Physiotherapy, Royal College of Surgeons in Ireland Faculty of Medicine and Health Sciences, Dublin, Leinster, Ireland 3 Primary Care Services, Health Services Executive, Ireland, Ireland 4 University College Cork School of Public Health, Cork, County Cork, Ireland 5 University College Cork Department of General Practice, Cork, County Cork, Ireland 6 Department of Economics, University College Cork Business School, Cork, County Cork, Ireland 7 University College Cork School of Applied Psychology, Cork, County Cork, Ireland 8 PPI Ignite, University College Cork, Cork, County Cork, Ireland 9 Graduate School of Healthcare Management, Royal College of Surgeons in Ireland Faculty of Medicine and Health Sciences, Dublin, Leinster, Ireland 10 Glasgow Caledonian University School of Health and Life Sciences, Glasgow, Scotland, UK Ruth McCullagh Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing N.Frances Horgan Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Caroline Eldridge Roles: Data Curation, Formal Analysis, Investigation, Project Administration, Writing – Original Draft Preparation Katherine Thackeray Roles: Data Curation, Formal Analysis, Investigation, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Eibhlis Cahalane Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Resources Vanda Cummins Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Project Administration, Resources Edel Brennan Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Project Administration, Resources Leanne Ahern Roles: Formal Analysis, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Brendan Palmer Roles: Data Curation, Formal Analysis, Software Tony Foley Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Sheena McHugh Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Aileen Murphy Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Annlisa Setti Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Emmy Racine Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Éidín Ní Shé Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Writing – Original Draft Preparation Dawn Skelton Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS AWAITING PEER REVIEW This article is included in the Ageing Populations collection. Abstract Falls and fall-related injuries in older people are common, with negative effects on functional independence, social engagement and quality of life. The estimated cost of falls related injuries in Ireland, including primary, acute and social care costs, is projected to exceed €2 billion by 2030. The COVID-19 pandemic led to an increase in frailty and falls. Falls Management Exercise Programme (FaME) is a 24-week community-based group and home exercise programme led by qualified Postural Stability Instructors. It has been shown to reduce falls, and improve physical activity levels, physical function and wellbeing. FaME was first introduced in Ireland in 2021, and there are 120 specialist instructors trained to deliver FaME. We want to find the best way to get FaME implemented cost effectively in Ireland. How can we best establish FaME, ensuring we reach everyone who may fall, deliver FaME effectively and appropriately, and support people to keep living their best life after the programme? Although much has been learned regarding implementation of FaME in the UK, it is important to consider the implementation of FaME in an Irish context, where systems and cultures are different. By learning from and working with the specialist instructors at the early adopter sites, using mapping, observation, gap analysis, surveys, interviews, focus groups and workshops throughout, aligning our evaluation to the AFFINITY Project logic model and the Health Services Executive Change Guide we will ‘Define, (co-)Design, Deliver and Disseminate’ our findings based on equity and reach, efficiency, appropriateness and sustainability, suitable physical activity options after the programme, and cost analysis for different scenarios of delivery. Working closely with PPI, Knowledge Users and an International Expert Group, we will deliver a FaME Community of Practice with a fit for purpose FaME Toolkit, synthesising the learning for future implementation across Ireland. READ ALL READ LESS Keywords Accidental Falls, Exercise Therapy, Aged, Preventive Health Services, Independent Living, Hip Fractures, Exercise, Psychological Well-Being Corresponding Author(s) Ruth McCullagh ( [email protected] ) Close Corresponding author: Ruth McCullagh Competing interests: Prof Dawn Skelton declares their role as a Director of Later Life Training Ltd, a not-for-profit organisation running falls prevention exercise training in the UK, Europe and Singapore for health and exercise professionals. All other authors disclose they have no competing interests. The authors disclose that that AI technology was not used in generating this report, nor it planned to be used in future manuscript or report productions. Grant information: Health Research Board [APA-2022-028]. The partner for this application is the Health Service Executive. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 McCullagh R 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: McCullagh R, Horgan NF, Eldridge C et al. Falls Management Exercise programme: Improving reach, effectiveness, value and sustainability in Ireland. Case studies for learning (acronym: FaME Ireland): protocol of an observational evaluation study [version 1; peer review: awaiting peer review] . HRB Open Res 2025, 8 :56 ( https://doi.org/10.12688/hrbopenres.14115.1 ) First published: 24 Apr 2025, 8 :56 ( https://doi.org/10.12688/hrbopenres.14115.1 ) Latest published: 24 Apr 2025, 8 :56 ( https://doi.org/10.12688/hrbopenres.14115.1 ) Background Falls are common, with over one third of those aged 65 and older falling each year. Falls can lead to injuries and admission to hospital or care homes ( Montero-Odasso et al. , 2022 ). Prevention and management of falls is a critical global challenge ( Montero-Odasso et al. , 2022 ). The COVID-19 pandemic led to an increase in frailty and falls, resulting from reduced physical function due to reduced leisure and incidental physical activity during cocooning and social restrictions ( Bailey et al. , 2021 ) and falls are also associated with COVID-19 infection and long COVID ( Nguyen et al. , 2022 ). Last year, the HSE activity update shows a continuing increase in over-75s attendance at Irish hospital emergency departments. Ensuring that older people can access falls exercise as ‘treatment’ and as a ‘prevention strategy’ is vital to meet the need of the coming ‘rehabilitation pandemic’. In Ireland, in 2021 the population of >65s reached 742,300, is projected to rise to 1 million within 10 years (CSO 2021/22) and 1.6 million by 2051 (CSO 2021/22). The Irish Longitudinal Study on Ageing (TILDA) reported that 19% of people aged >50 fall annually ( Bhangu et al. , 2017 ), showing that strategies to prevent falls may need to start in middle age. In 2008, the direct and indirect cost of fractures was €225 million, with an average inpatient stay of 4.1 days for a wrist fracture, 17.1 days for a hip fracture ( Gannon et al. , 2008 ). In 2023, 3983 patients aged >60 were admitted with hip fracture attributable to low trauma falls, mostly happening in the home ( NOCA, 2023 ). With projected increases in the population, the estimated cost of falls related injuries in Ireland, including primary, acute and social care costs, is projected to exceed €2 billion by 2030 ( Gannon et al. , 2008 ). Many falls are preventable ( Colon-Emeric et al. , 2024 ). Research has shown that exercise including strengthening and balance training is key to reducing falls. For maximum results, people need to exercise three times per week and to train balance and strength progressively and safely. The longer the programme, the greater the effect. FaME is a community-based falls management exercise program. It is six-months long, led by specialist training physiotherapists and exercise instructors. It has been shown to reduce falls, as well as improve physical activity levels and well-being ( Iliffe et al. , 2014 ; Skelton et al. , 2005 ). FaME was introduced in Ireland in 2021, and there are 120 specialist-instructors trained to deliver FaME this year. We know the programme works, however, in this study, we want to find the best way to get FaME up and running well in Ireland, linking well with the Irish healthcare system. Specifically, our goals are to reach everyone who may fall, and to deliver it appropriately and effectively for everybody. We also want to find other exercise or activity programs that people like so that we can encourage participants to keep active and independent after they complete the FaME programme. This study aims to describe, understand and evaluate current practice, to co-design adaptations to improve identified weaknesses or threats, and finally, to implement and measure the effects of the adaptations in practice. Using the HSE Health Services Change Guide ( Health Services Executive, 2018 ), the work packages include (1) DEFINE : the definition and evaluation of current implementation practices by collecting process, outcome, and cost data [both qualitative and quantitative data], (2) DESIGN : co-design workshops to find suitable adaptations, and (3) DELIVER : re-evaluate the adapted delivery. Methods This hybrid observational evaluation study examines FaME implementation in Ireland, utilizing the existing network of specialist trained Postural Stability Instructors (PSIs) and programmes. PSIs are trained by Later Life Training ( www.laterlifetraining.co.uk ), supported by the AFFINITY Project ( CES, 2019 ). There has been patient and public involvement (PPI) in the planning of the study and will continue to review the materials and processes. This protocol will be reported in line with Standardised protocol Items Recommendation for Observational Studies (SPIROS 2023). The intervention: Falls Management Programme (FaME) The Falls Management Programme (FaME) is a tailored group exercise programme shown to reduce falls by up to 54% and increase physical activity to recommended levels ( Iliffe et al. , 2015 ; Orton et al. , 2021 ; Skelton & Dinan, 1999 ; Skelton et al. , 2005 ). It involves 24 weekly 1-hour group sessions (10–12 participants) led by PSIs, supplemented by individual home exercises. Essential components include progressive strength, balance, endurance, flexibility training, and adapted Tai Chi. Equipment includes weights, resistance bands, and mats. Sessions conclude with social time, and exercise preferences are explored midway to support sustained activity. Currently in Ireland, FaME is delivered by Physiotherapist PSIs (for six weeks) and then continued by the Exercise Professional PSIs, in community venues, with the aim to fast track people away from clinical care to exercising beneficially in the community. Location and setting The programme is implemented at three primary care/community sites. FaME is Initially delivered in healthcare settings by physiotherapist-PSIs for the first six weeks, transitioning to exercise professional-PSIs for the remaining 18 weeks 1. Dublin (urban): Delivered in gyms with public transport access, overseen by PSIs and site researchers. 2. Kerry (rural): Delivered in local facilities with limited public transport, overseen by PSIs and site researchers. 3. Leitrim (rural): Led by a Falls Coordinator with a strong physiotherapy-PSI collaboration. The Falls coordinator will not attend all classes, but will have weekly meetings. Risk assessments and supervision are prioritized across all sites. Eligibility criteria for participants FaME is suitable for people with a history of falls and those deemed to be at high risk of falling. In this study, we will use the existing eligibility criteria for the service. In the early adopter sites, people must be referred from their healthcare provider (mostly primary care physiotherapists). This will be further explored in the co-DESIGN phase (see later) when we will explore the feasibility of other HCPs, social care providers and self-referral options into FaME to widen reach. Participants must be aged 65+, at risk of falls, living at home, medically stable, and physically capable of group exercise. Exclusion criteria include uncontrolled medical conditions, significant exercise-related BP changes, psychiatric conditions, or dependence on one-to-one therapy. We anticipate that we will recruit 80–100 participants over the three sites. This study will not aim to determine effectiveness; the sample size aims to get a strong representation of FaME participants, across the sexes, within the lifetime of the project. Ethical considerations . In line with the Declaration of Helsinki, local ethical approval has been granted for each site. Ethical approval for the study was provided by the Clinical Research Ethics Committee of the Cork Teaching Hospitals (CREC) [Ref Number EMC 4 (u) 14/05/2024 & ECM 3 (aaaa) 02/07/2024] and Sligo Research Ethics Committee [Ref 1019, 13/09/2024, 16/12/2024]. The HSE Research and Development office granted permission to proceed with the study in the Dublin site based on documents submitted, in line with the terms and conditions of CREC and in lieu of no HSE research ethics committee coverage in the Dublin primary care area. Written informed consent will be obtained from participants, including commissioners, instructors, and service-users. All participants must provide informed consent. The PSIs will inform the FaME participants of the study and provide the information packs. All the research team will be available to ask any questions and will gather written informed consent. Copies of the forms will be available on request. Participating in FaME exercise sessions is safe, thanks to the PSIs' skilled training and ability to tailor exercises to reduce fall risk. All research assessments are non-invasive and are low-risk. While adverse events are unlikely, any that occur will be recorded and categorized. If an adverse event happens, appropriate care will be provided following HSE guidelines. Potential risks will be discussed during the informed consent process. To prevent fatigue, breaks will be included between assessments. Family members are welcome to support participants throughout the project. Data protection information is detailed in Section 6: Data Protection Information. Implementation evaluation research design The FaME-Ireland evaluation design, developed in collaboration with health service professionals, previous FaME participants, and policymakers, follows the AFFINITY National Falls and Bone Health Project framework ( CES, 2019 ). Please see Figure 1 study flow-chart. Figure 1. Define, Design, Deliver: Change Activities. The project follows the HSE Health Services Change Guide ( Health Services Executive, 2018 ) is divided into three work packages (DEFINE, coDESIGN, DELIVER) ( Figure 2 ) utilizing a multi-method approach to assess the FaME programme’s process, outcomes, impact, and value. 1. In DEFINE , the current practices will be explored and examined to determine good practice and areas for improvement. 2. In co- DESIGN , a local co-DESIGN workshop involving local stakeholders will work together to find local practical solutions. 3. In DELIVER , the adapted practice will be explored using the same methods as DEFINE , to identify the impact of the adaptations. Figure 2. FaME Ireland Flow Diagram for DEFINE and DELIVER phases. Finally, we will “Disseminate” through public meetings, workshops, and short video production to inform people about falls prevention and exercise. The UK FaME Implementation Toolkit will be adapted for the Irish context. Reports and presentations will be generated for the ethics boards and will be published open access to increase clinical, medical and public awareness. Work package 1 and 3: DEFINE and DELIVER DEFINE aims to examine current practices, and DELIVER will examine adapted practices, after the local co-DESIGN workshops. Firstly, the only activity not to be repeated in DELIVER is a national survey conducted exploring all trained PSIs’ experience of setting up and maintaining a FaME programme. Secondly, at three early adopter sites ( Kerry, Dublin, Leitrim ), a mixed methods local evaluation will be conducted. These three sites represent both urban and rural settings, and less and more established programmes. The work package will continue for the 32 weeks, ie., the full length of the programme with a follow-up period. Four key themes will be examined: Reach and equity Through examination of referral pathways, participant type, we aim to identify gaps of knowledge and access equity for participants. 4. Analyse referral patterns and participant types including differences between sexes 5. Interview referring physiotherapists about the reach of FaME to potentially underserved communities. Indicators of Reach include gaps in referral pathway, and participant types who fail to reach the classes. Efficiency, appropriateness, effectiveness, cost and sustainability of FaME Through PSI national survey and local interviews, observation of the programme, and analysis of participant outcomes, we will aim to describe the threats to sustaining the service, measure its effects and efficiency in the Irish context, and identify the necessary supports for treatment fidelity. Through participant interviews and programme observations, we aim to describe levels of participant readiness, satisfaction, perceived appropriateness. 1. Survey trained PSIs to assess threats and opportunities to FaME delivery. 2. Observe one class at each site to evaluate time resources, exercise progression, individualization, and participant numbers. 3. Interview PSIs about venue suitability, time/resource allocation, safety issues, participant numbers, fidelity challenges, and financial viability. 4. Interview FaME participants to assess readiness, venue suitability, required participant numbers, dropout and re-entry, safety, satisfaction, perceived gains, and enjoyment. 5. Measure attendance, drop-outs, referrals, waiting lists, and effects. 6. Complete a cost analysis of the intervention (including training, time, venue, equipment, refreshments, and travel costs) 7. Complete a sensitivity analysis to compare differing local methods of delivery and patient presentation Indicators of Efficiency, Appropriateness, Effectiveness, and Sustainability include threats to sustained delivery, levels of effectiveness and efficiency, appropriate support for fidelity, participant readiness, satisfaction, and perceived appropriateness. People routinely miss classes over the 26 weeks of the programme; PSIs are trained to contact non-attenders to encourage them back to the class. A 20% attrition rate can be anticipated. Indicators of current cost will include the expenses of implementing FaME using different delivery methods. Sustaining physical activity and independence after FaME Through interviews and three-month follow-up assessments, we will aim to identify suitable options to remain physically active, indicators of sustained PA and independence, and perceived acceptability and satisfaction of physical activity options. 1. Profile participants’ exercise preference, examining for differences between the sexes. 2. Explore options to keep active after FaME for all participants. 3. Measure falls rate, self-efficacy, and physical activity after the programme. 4. Conduct focus groups at completion to assess the acceptability of options, reasons for choices, satisfaction, and perceived self-efficacy (in their classes) 5. Conduct three-month brief follow-up phone interviews (20% purposive sample) to measure physical activity, falls, self-efficacy, and qualitative indicators of self-efficacy, independence, and exercise. Indicators of keeping physical active and independent after FaME will include preferred options for exercise and perceived confidence to progress to a different exercise programme/activity, measures of PA up to three months after the programme. Data collection procedures See Table 1 for an overview of data collection. Data collection will include interviews with referrers, PSIs, and participants to identify knowledge gaps and perceived sustainability threats. All interviews will be completed by the research team, unknown by the FaME participants to encourage open dialogue. Training will be provided by the principal investigator, experienced in conducting and supervising qualitative research. Topic guides will be refined prior to the interviews and will be iteratively adapted through regular discussion of emerging themes. Field notes will support self-reflexivity, which will be considered in the analysis. Early interviews will explore local referral practices, and PSIs’ experience of running the programme. Interviews with participants will be conducted half-way, at completion and at 6 weeks follow-up. All data collection will happen locally, in-person or through MS Teams, if preferred. Table 1. Overview of Data Collection DEFINE/DELIVER. Aim Data Collection Time Description Explore: Perceived barriers. threats and opportunities Method: Survey x1 Among: All trained PSIs in Ireland Via: Qualtrics DEFINE Week 1-10 Supplemental files https://osf.io/m2ds7/ Explore: Referral patterns, Gaps in referral pathway, participants failing to reach FaME Method: Semi-structured interview x1 Among: referring primary care physiotherapy services By: Research Assistants DEFINE, DELIVER Week 1-10 Supplemental files https://osf.io/m2ds7/ Explore: Treatment fidelity to the essential components Method: Observation x1 Among: PSIs at sites By: Later Life training DEFINE, DELIVER Week 10-16 Supplemental files https://osf.io/m2ds7/ Explore: Perceived efficiency and sustainability and cost Method: interview Among: PSI (x1) and commissioners (x1) By: Research Assistants DEFINE DELIVER Week 10-26 Supplemental files https://osf.io/m2ds7/ Explore: Perceived appropriateness, satisfaction, and physical activity after FaME Method: interview (x3) Among: FaME service-users By: Research Assistants DEFINE, DELIVER Week 10-12 Week 26 (planned PA) Week 30-36 (actual PA) Supplemental files https://osf.io/m2ds7/ Measure: Uptake, attendance, drop out and effects Method: Administrative data, Baseline and outcome data (x1) By: Research Assistants DEFINE, DELIVER Week 26 Table 2: Baseline and outcome measures https://osf.io/m2ds7/ Baseline and outcome data will be used to assess the effects of FaME (see Table 2 ) and will primarily be collected by the PSIs. Every attempt will be made to collect complete data sets from consented participants. The PSI training ensures competency in conducting these measurements. Supplemental files available at https://osf.io/m2ds7/ provide a complete description of the instruments. Table 2. Baseline and outcome measures DEFINE/DELIVER. Measures Baseline PSI Completion PSI Completion RA Follow up RA Age X Gender X Falls history in last 6 months X X (last 3 months) X Ethnicity X Postcode X Medical conditions X X Prescribed medications X X Timed up and Go X X 180 deg turn X X Functional reach X X 30s chair rise X X 4-point balance (one leg stance eyes open) X X Balance confidence (ConfBal) X X Quality of Life (EQ-5D) X X Fear of Falling (FES-I) X X Self-reported Physical Activity* X X X Clinical Frailty Scale X X FRAT Score X X Attendance at group X Engagement in home exercise programme X Progression of strength training (weight/band colour) X Adverse events within FaME sessions X X Adverse events outside of FaME sessions (eg. hospitalisations/falls) X X X Intention to join other exercise/activity programmes X Joined other exercise/activity programmes X Satisfaction (venue/PSI/outcomes) X X Views/experiences X X Data analysis All quantitative process measures, baseline functional assessments and outcomes will be described using frequencies, percentages, means and standard deviations, medians and interquartile ranges and rates as appropriate. Because this study is not powered to show effect in falls or physical function, effectiveness on physical function and change in falls status will be considered using change from baseline scores. Missing data will not be imputed. The proportions of patients reaching the recommended government target of at least >150 mins moderate or vigorous physical activity per week will be compared using chi-square tests. The data will inform the effects of FaME, characteristics of FaME participants, differences between the sexes, class uptake, adherence and adverse events. Evaluation of the implementation (structure/process/outcome) measures will be completed qualitatively through in-depth semi-structured interviews and focus groups. Data will be transcribed verbatim and checked for verification. Thematic analysis using Braun and Clarke reflexive thematic analysis with two independent researchers will be utilised ( Braun & Clarke, 2019 ). An economic evaluation will be completed to determine the cost of the service provision. The qualitative analysis will inform us of access, acceptability, satisfaction, and perceived impact on physical activity, function and social engagement. Good practice and areas to consider for change will be brought to the local co-DESIGN event. Co-DESIGN The local co-DESIGN workshops will be held after the DEFINE phase. They will bring local stakeholders together to celebrate excellent practice, and to agree on practical solutions for issues found in the DEFINE phase. To involve all stakeholders: FaME participants, caregivers, health care professionals, PSIs and older adults' advocacy, we will use the World Café method of co-DESIGN. This approach fosters community and organizational collaboration by using smaller, similar groups to encourage empowerment and openness, especially among FaME participants and family members. It also allows for a one-day workshop, reducing commitment demands. The co-DESIGN workshops will be held locally at early adopter sites, with lead site researchers attending all three sessions. This setup minimizes participation burden while promoting cross-site collaboration. The researcher team will facilitate these workshops, but the clinical services will be responsible for agreeing on local solutions or implementing changes to FaME delivery. World Café methodology The World Café methodology is a structured, conversational process designed to foster collaborative dialogue, share knowledge, and develop practical plans. It follows seven principles to enhance outcomes and involves small round-table discussions where participants engage in multiple conversation rounds on a specific topic. Each table has a \"host\" who remains while others rotate, connecting ideas across groups. The informal, café-like atmosphere promotes open dialogue and creative thinking. Insights are captured on paper, allowing diverse participants to build on each other's ideas and generate innovative solutions. Questions to be discussed The data collected in DEFINE will guide the questions for co-DESIGN discussions. Emerging data highlight key issues at both the local level (e.g., access, facilities, delivery) and broader national level (e.g., resources, interagency collaboration, cost). Therefore, we propose inviting both local stakeholders and national representatives of key authorities to the co-DESIGN process ( Table 3 ). Table 3. Representatives of key stakeholder groups and authorities for the co-DESIGN workshop. Service user representation Local FaME participant Older adults advocacy (Age and Opportunity) PPI co-applicant (public representative) Service provider representation Physiotherapy PSI Exercise professional PSI Service provider training Local Service Management HSE local service management HSE local regional representative Commissioning charity National Authority Management HSE Integrated Care Pathway for Older People Local Sports Partnership Representative Research Local site researchers Facilitator for each table Members of FaME Ireland Core Management Team PPI: Public Patient Involvement HSE: Health Services Executive Participants Participants will include the following and will be adapted in response to the emergent themes of the DEFINE data at each early adopter site. We will aim to limit the number to less than 20 people to foster a deeper conversation on the questions poised, aiming to get balance between the sexes. The core team will select suitable participants for each local café and invite them through the appropriate team member. Participants will be informed about the Café’s purpose, commitment, and expectations. The context, goals, and discussion questions will be clearly outlined, along with procedures for recording, analysing, and publishing the data. Participants will have the opportunity to ask questions before giving consent. Procedure The Café will be held in a convenient location with good parking and access. To create a welcoming, open environment, small tables with paper for writing will be set up for group discussions. The session will begin with a presentation to set the context, covering FaME evidence, participant journeys, and emergent questions from DEFINE. The process, facilitators, and Café Etiquette will be introduced. Groups will be prearranged to foster openness and effectively address the questions. Hosts will guide discussions towards identifying local solutions, with verbal summaries captured at each table. Notes and doodles will be collected for analysis. Participants will be encouraged to add their thoughts, enriching the conversations. Groups will rotate between tables to build on ideas, with time to reflect on emerging themes. After all rounds, the group will reconvene to share insights, patterns, and recommendations. A more detailed report will be sent to all participants after the workshop. The data will be analysed for strategic planning. Actionable items will be prepared for the DELIVER phase, while other important strategic actions will be compiled into a report for future planning. Data analysis ensuring trustworthiness After the session, all materials, including flipcharts notes and doodles, will be collected. The data will be organized by the questions discussed during the rounds and note-keeping data to emerging themes. Thematic analysis will identify recurring patterns or ideas, with key phrases or concepts being coded. Connections or unique insights will be highlighted, using visual methods like mind maps or thematic networks to display relationships. The codes will be grouped into broader categories, which will be further refined into themes, supported by illustrative quotes for credibility. Findings will undergo member checking by a core group of participants to ensure accuracy. The core research team, along with PPI representatives, will translate the findings into actionable outcomes. Outcomes will inform the DELIVER phase. Some will be actionable, while other actions will guide future planning and innovation opportunities. The research process will be recorded, and the protocol pre-registered to ensure confirmability. This approach ensures data effectively guides decision-making and future research. DELIVER The agreed action plans will be implemented during the DELIVER phase. To assess the impact, the service will be re-evaluated measuring the same indicators as the DEFINE phase. Participants in the DELIVER phase will include current FaME service users, instructors (PSIs), service managers, and referring physiotherapists at the three early-adopter sites. An economic analysis will be completed to illustrate the economic impact of practices. Data collected will be compared to the DEFINE status, to understand the impact of the changes. Practices that show a positive impact will be included in the Implementation Toolkit, adapted from the UK Implementation Toolkit. Data protection information This study is sponsored by University College Cork, with researchers from the Discipline of Physiotherapy. Key partners include Glasgow Caledonian University, UK, and the Royal College of Surgeons in Ireland, Dublin. The study is funded by the Health Research Board (Applied Partnership Award) and co-funded by the Health Services Executive. The full data management plan is available at OSF FaME Ireland ( McCullagh, 2025 ). The study can be audited at any time by the Health Research Baord, and annual reports are submitted detailing progress and budget. DEFINE and DELIVER phases Data will include qualitative, survey and quantitative data. Qualitative data Most data will be qualitative, collected through interviews with participants, instructors, and commissioners, conducted via MS Teams or in-person. MS Teams interviews will be recorded and saved on UCC’s cloud storage, while in-person interviews will be audio-recorded using a Dictaphone. These recordings will be transcribed and stored on UCC’s cloud storage platform for analysis. Once transcripts are verified, the original recordings will be deleted. All transcripts will be pseudo-anonymized before sharing with the research team, with a separate key stored securely to link data. After each interview, recordings will be transferred to an encrypted laptop and deleted from the recording device. Identifying information will be removed from transcripts and be pseudo-anonymized. Only the anonymized transcript will remain, stored on UCC’s OneDrive for ten years. The key linking participant data to study numbers will be securely kept in a locked cupboard in a restricted access room. All data will be stored for ten years. Survey data A survey will be conducted via UCC Qualtrics during the DEFINE phase. All information will remain confidential and anonymized. No personal information will be collected, but participants will be asked for their location and profession to aid in data interpretation. Responses cannot be traced back to individuals. The anonymous data will be stored on University College Cork’s OneDrive platform for ten years and shared with the research team. Outcome data The outcome measures routinely collected by instructors will be analysed to assess the effects and efficiency. These measures are taken at the beginning and on completion of the program during both the DEFINE and DELIVER phases and do not require additional procedures from participants. The data will be pseudo-anonymized before being shared with the research team, meaning only the instructor who took the measurements will be able to identify them as belonging to a specific participant. Permission to re-use anonymised data For all data, we will also ask permission to use the anonymised data in future studies, noting that any future studies will be approved by a research ethics committee. Procedures to minimise data breach To minimize the risk of a data breach, the following procedures will ensure the safety, confidentiality, and anonymity of participant information: 1. Only the research team will have access to the data. The data will be entered on a secure database platform. Data quality processes will be used including dropdown, range checks, and time stamped entry. 2. The data will be linked to participants solely by the person who collected it. Once collected, the data will be pseudo-anonymized (assigned a unique identifier) before being shared with the research team. 3. The pseudo-anonymized data will be stored on a password-protected computer file. 4. The data will not be shared with anyone outside the research group. 5. A secure list, or ‘key’, linking participants to their study number will be stored on the UCC secure IT system with restricted access. Co-DESIGN workshops Data will include written notes from the co-DESIGN workshops. Note keeping material All note-keeping materials will be collected at the end of the Café. These notes will be converted into PDF documents and stored on the University College Cork OneDrive platform for ten years. The documents will be accessible only to the research team. Permission to re-use anonymised data For all data, we will also ask permission to use the anonymised data in future studies, noting that any future studies will be approved by a research ethics committee. Procedures to minimise data breach To minimize the risk of data breach, the following procedures will be implemented to ensure information remains safe, confidential, and unidentifiable: 1. Only the research team will have access to the data. 2. The person who collects the data will be the only individual able to link it to a participant. After collection, the data will be anonymised. 3. The anonymised data will be stored on a password-protected computer file. 4. The data will not be shared with any party beyond the research group. Data availability Underlying data No data are associated with this article. Extended data Open Science Framework: Falls Management Exercise Programme: Improving Reach, Effectiveness, VaLue and SustAiNability in IrelanD. Case Studies for Learning (acronym: FaME Ireland). https://doi.org/10.17605/OSF.IO/M2DS7 ( McCullagh et al. , 2025 ). This project contains the following extended data: - SPIROS checklist for this report ( Mahajan et al. , 2025 ) - Interview topic guides - Baseline and outcome measures - Examples of participant information sheets are available Data are available under the terms of the Creative Commons Zero \"No rights reserved\" data waiver (CC0 1.0 Public domain dedication). Study registration The study is registered on the ISRCTN Clinical Study Register [ISRCTN85505403 https://doi.org/10.1186/ISRCTN85505403 ] Authors contributions Conceptualization DS, FH, RMC, EB, EC, VC Data Curation RMC, KT, CE, LA, BP Funding Acquisition DS, FH, RMC, EB, EC, VC, TF, SMH, AM, AS, ER Investigation EB, VC, EC, KT, CE, RMC, LA Methodology DS, FH, RMC, ENS, AM, SMH, AS, ER Formal analysis RMC, LA, BP, AM, Resources EC, EB, VC, FH, ER Project Administration RMC, CE, KT, LA, FH, DS Supervision DS, FH, RMC, EB, EC, VC, AS, ER, TF, AM, SMH Writing DS, FH, RMC, EB, EC, VC, KT, CE, LA Acknowledgements We would like to acknowledge the contributions of the following: Ms Helen O’Keeffe, HSE, for her continuing support and contribution to this project and Mary Harkin, Age and Opportunity, for their support and guidance on the PPI roles in the project. 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Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 24 Apr 2025 ADD YOUR COMMENT Comment Author details Author details 1 Discipline of Physiotherapy, University College Cork School of Clinical Therapies, Cork, Ireland, T12 X70A, Ireland 2 School of Physiotherapy, Royal College of Surgeons in Ireland Faculty of Medicine and Health Sciences, Dublin, Leinster, Ireland 3 Primary Care Services, Health Services Executive, Ireland, Ireland 4 University College Cork School of Public Health, Cork, County Cork, Ireland 5 University College Cork Department of General Practice, Cork, County Cork, Ireland 6 Department of Economics, University College Cork Business School, Cork, County Cork, Ireland 7 University College Cork School of Applied Psychology, Cork, County Cork, Ireland 8 PPI Ignite, University College Cork, Cork, County Cork, Ireland 9 Graduate School of Healthcare Management, Royal College of Surgeons in Ireland Faculty of Medicine and Health Sciences, Dublin, Leinster, Ireland 10 Glasgow Caledonian University School of Health and Life Sciences, Glasgow, Scotland, UK Ruth McCullagh Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing N.Frances Horgan Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Caroline Eldridge Roles: Data Curation, Formal Analysis, Investigation, Project Administration, Writing – Original Draft Preparation Katherine Thackeray Roles: Data Curation, Formal Analysis, Investigation, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Eibhlis Cahalane Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Resources Vanda Cummins Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Project Administration, Resources Edel Brennan Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Project Administration, Resources Leanne Ahern Roles: Formal Analysis, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing Brendan Palmer Roles: Data Curation, Formal Analysis, Software Tony Foley Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Sheena McHugh Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Aileen Murphy Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Annlisa Setti Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Emmy Racine Roles: Funding Acquisition, Methodology, Writing – Original Draft Preparation Éidín Ní Shé Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Writing – Original Draft Preparation Dawn Skelton Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests Prof Dawn Skelton declares their role as a Director of Later Life Training Ltd, a not-for-profit organisation running falls prevention exercise training in the UK, Europe and Singapore for health and exercise professionals. All other authors disclose they have no competing interests. The authors disclose that that AI technology was not used in generating this report, nor it planned to be used in future manuscript or report productions. Grant information Health Research Board [APA-2022-028]. The partner for this application is the Health Service Executive. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (1) version 1 Published: 24 Apr 2025, 8:56 https://doi.org/10.12688/hrbopenres.14115.1 Copyright © 2025 McCullagh R 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. Download Export To Sciwheel Bibtex EndNote ProCite Ref. 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