Effectiveness and Cost-effectiveness of Home-Based Occupational Therapy with Activity Monitoring for Daily Functioning of People Post-Stroke: Protocol for a Partially Randomised Usual Care Stepped-Wedge Trial

Background Transitioning from a geriatric rehabilitation centre or hospital to home is challenging for persons post-stroke, as they must increase their ability to perform daily activities and self-manage their lives. Moreover, persons post-stroke exhibit more sedentary behaviour at home than during rehabilitation, which is detrimental to their health. The Occupational Therapy at Home E-Rehabilitation (OTHER) intervention aims to increase daily activities and self-management in persons post-stroke. OTHER involves in-person (online) coaching with information from activity monitoring. Here, we describe the design of a study investigating the (cost-)effectiveness of OTHER on the recovery of daily activities among older persons after stroke and evaluate its implementation process.

A partially cluster randomised stepped-wedge trial is conducted in nine geriatric rehabilitation centres and two hospitals, aiming to include 171 post-stroke participants (aged ≥ 60 years) who are starting (inpatient) rehabilitation to return home. The intervention group receives the OTHER intervention by an occupational therapist, starting at the institute and continuing at home. This intervention consists of activity monitoring to increase insight into movement behaviour, as well as coaching by occupational therapists on improving daily activities at home. This supports persons post-stroke in performing daily activities and increasing self-management. The control group receives care as usual. The primary outcome is the performance score of the Canadian Occupational Performance Measure, which measures a person’s perceived daily functioning at 6 months. A process evaluation will be conducted to assess the implementation process of the OTHER intervention during the research period.

This trial is studying the effect of activity monitoring combined with home-based occupational therapy coaching for persons post-stroke. With this study, we aim to provide insight into the effectiveness and cost-effectiveness of the OTHER intervention compared to care as usual for persons post-stroke, and describe the process of implementation, which includes home-based geriatric rehabilitation. Trial registration ClinicalTrials.gov: NCT05855226, and Organization’s Unique Protocol ID: 80-86900-98-022, registered may 11th 2023 Competing Interest Statement There are no conflicts of interest to declare. Clinical Trial ClinicalTrials.gov: NCT05855226, and Organization's Unique Protocol ID: 80-86900-98-022 Funding Statement Yes Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Medical Research Ethics Committee of Amsterdam UMC has approved the study (protocol ID 2022.0786) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Funding: The study is funded by ZonMW (grant ID 80-86900-98-022). Amsterdam University of Applied Sciences supports trial organisation, data management, and monitoring. Competing interests: There are no conflicts of interest to declare. Data availability: All relevant data from this study will be made available upon request after study completion. Data Availability No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.