Co-designing a Stroke Rehabilitation Trial Toolkit

Summary

Clinical trials are a type of research that tests if a treatment works well and is safe, so future care can be improved. In stroke rehabilitation, clinical trials are essential for improving the lives of stroke survivors. Clinical trials follow detailed plans called protocols, that explain what activities should be done, by whom and when. This makes sure everyone in the trial does things the same way, so results are fair and consistent. Sometimes, stroke survivors or staff may not follow the trial protocol exactly. For example, someone might miss a session or do different exercises. This is called low adherence. There are many reasons this can happen; the exercises or schedule may be too hard, the trial or activities do not match what stroke survivors or staff need, prefer, or find helpful in real life. If protocols are not followed properly, the trial results of clinical trials may not be reliable. This can slow down the process of getting better treatments into hospitals and make it harder to improve rehabilitation for future stroke survivors.

Previous research has looked at what helps and gets in the way of adhering to protocols during hospital-based stroke rehabilitation trials. The research has identified many factors, including the healthcare system, hospital environment, staff, patients and the rehabilitation activities or schedules. Most of this research focused on the views of staff involved, meaning important perspectives may be missing from others involved in stroke rehabilitation trials.

The investigators' study aims to change that. The investigators want to hear from people whose voices are often overlooked: stroke survivors, their family and friends, stroke rehabilitation staff and healthcare leaders working in the NHS, stroke rehabilitation researchers, staff working in Integrated Care Boards (who help plan and coordinate NHS services in local areas) and representatives from organisations who fund stroke rehabilitation research. The investigators will use a process called co-design. This means working together to develop a toolkit to help improve adherence in future stroke rehabilitation trials.

Toolkits are already used in healthcare to help people do things better. For example, changing how care is given, supporting patients, or helping health teams work more smoothly. But currently, there is no toolkit designed specifically to help improve adherence to stroke rehabilitation trial protocols.

This research aims to design a toolkit together. The toolkit will be shaped by a wide range of voices, especially those from underrepresented groups, and made in a way that's easy to understand and use.

By addressing potential barriers early on, the investigators hope the toolkit will make it easier for future stroke rehabilitation trials to succeed, leading to better recovery and quality of live for stroke survivors.

Conditions

• Stroke
• Rehabilitation
• Co-design

Interventions

OTHER

Co-designing a stroke rehabilitation toolkit

STAGE 1 NATIONAL ONLINE SURVEY: to capture a broad range of views from those involved in stroke rehabilitation trials, e.g. all groups. This will help identify key themes for deeper exploration in STAGE 2. STAGE 2 INTERVIEWS: with up to 14 participants, a mix of research partners. Interviews will be online via Zoom or Microsoft Teams. Interviews will be audio recorded. A short film, called a catalyst film, will be created from the survey and interviews. STAGE 3 JOINT DISCUSSIONS: Approximately 16 participants; a mix of all groups will attend a 2-hour joint event. The catalyst film created from STAGES 1 and 2 will be shown. STAGE 4 CO-DESIGN WORKSHOPS: Three co-design workshops will take place over the course of 8 weeks. Up to 20 participants (a mix of groups). STAGE 5: CELEBRATION EVENT: showcase the co-designed outcomes, celebrate participant contributions, and share learning with wider stakeholders.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust

  collaborator OTHER

• University of Plymouth

  lead OTHER

Principal Investigators

• Jonathan Marsden, PhD · University of Plymouth

• Angie Logan, PhD · University of Plymouth

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-26

Primary Completion

2027-01-31

Completion

2027-12-31

Countries

• United Kingdom

Study Locations