Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-03 @ 2:04 PM
Study NCT ID:
NCT07484958
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-20
First Post:
2026-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Co-designing a Stroke Rehabilitation Trial Toolkit
Sponsor:
University of Plymouth
Organization:
Study Overview
Official Title:
Co-designing a Toolkit to Optimise Adherence to Inpatient Stroke Rehabilitation Trial Protocols
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Robust stroke rehabilitation trials are essential for advancing evidence-based practice. These trials rely on adherence to detailed protocols that specify the treatment content, delivery, frequency, and data collection methods. However, when protocols are not adhered to (low adherence) this compromises the reliability and validity of trial outcomes, leading to research waste and delays translating evidence into clinical practice, ultimately hindering recovery for stroke survivors.
A mixed-methods systematic review of hospital-based rehabilitation clinical trials identified multiple barriers and facilitators to protocol adherence for hospital-based rehabilitation trials: innovation (rehabilitation intervention), outer setting (healthcare system), inner setting (hospital/organisation), individuals (leaders, intervention deliverers and recipients) and implementation (activities/strategies to deliver the intervention). The systematic review provides critical insights to inform future trial design and implementation. However, the findings predominantly reflect staff perspectives and are drawn from individual stroke rehabilitation trials, potentially limiting generalisability across broader contexts. Thus, the aim of the research is to gather underrepresented voices to understand the knowledge, skills, techniques and behaviours needed to improve and maintain adherence to stroke rehabilitation protocols. The investigators will work together with stroke survivors, family member/friend of stroke survivor, stroke rehabilitation staff and researchers, healthcare leaders, staff from Integrated Care Board/Systems and funders (hereon in referred to as research partners) using Experience-Based Co-Design (EBCD). EBCD brings together lived experience, lived expertise and professional experience to learn from each other to design a toolkit that meets the needs and preferences of all.
Toolkits have been widely used in health as a way of knowledge translation, aim to improve behaviours among healthcare staff, consumers, organisations, policy makers and the public. They typically consist of a collection of resources practical tools designed to support the implementation and uptake of a treatment or process. The content and format of toolkits can vary depending on the health condition, target users, clinical setting, and individual needs and preferences. However, there is no existing toolkit to help improve adherence in stroke rehabilitation clinical trials. This study specifically addresses the need to develop a toolkit to optimise adherence to inpatient stroke rehabilitation clinical trial protocols.
The investigators will co-design a toolkit based on the diverse needs and priorities of the research partners and will incorporate evidence-based methods to ensure reach to underserved groups. They will ensure that the languages, strategies and information is accessible and relatable to different communities of individuals.
The investigators will consider potential barriers and solutions to implementation throughout to ensure successful adoption of a toolkit in future inpatient stroke rehabilitation trials.
A mixed-methods systematic review of hospital-based rehabilitation clinical trials identified multiple barriers and facilitators to protocol adherence for hospital-based rehabilitation trials: innovation (rehabilitation intervention), outer setting (healthcare system), inner setting (hospital/organisation), individuals (leaders, intervention deliverers and recipients) and implementation (activities/strategies to deliver the intervention). The systematic review provides critical insights to inform future trial design and implementation. However, the findings predominantly reflect staff perspectives and are drawn from individual stroke rehabilitation trials, potentially limiting generalisability across broader contexts. Thus, the aim of the research is to gather underrepresented voices to understand the knowledge, skills, techniques and behaviours needed to improve and maintain adherence to stroke rehabilitation protocols. The investigators will work together with stroke survivors, family member/friend of stroke survivor, stroke rehabilitation staff and researchers, healthcare leaders, staff from Integrated Care Board/Systems and funders (hereon in referred to as research partners) using Experience-Based Co-Design (EBCD). EBCD brings together lived experience, lived expertise and professional experience to learn from each other to design a toolkit that meets the needs and preferences of all.
Toolkits have been widely used in health as a way of knowledge translation, aim to improve behaviours among healthcare staff, consumers, organisations, policy makers and the public. They typically consist of a collection of resources practical tools designed to support the implementation and uptake of a treatment or process. The content and format of toolkits can vary depending on the health condition, target users, clinical setting, and individual needs and preferences. However, there is no existing toolkit to help improve adherence in stroke rehabilitation clinical trials. This study specifically addresses the need to develop a toolkit to optimise adherence to inpatient stroke rehabilitation clinical trial protocols.
The investigators will co-design a toolkit based on the diverse needs and priorities of the research partners and will incorporate evidence-based methods to ensure reach to underserved groups. They will ensure that the languages, strategies and information is accessible and relatable to different communities of individuals.
The investigators will consider potential barriers and solutions to implementation throughout to ensure successful adoption of a toolkit in future inpatient stroke rehabilitation trials.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: