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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survey, individual interviews, and group discussions This is co-design research the output will be the co-designed toolkit.', 'timeFrame': 'Time Frame: From March 2026 to February 2027', 'description': 'STAGE 1 SURVEYS:\n\nTotal number of surveys completed which will be categorised by participant groups, e.g., stroke survivors, family/friend of stroke survivor, stroke rehabilitation staff, healthcare leader, stroke rehabilitation researcher, funder.\n\nData will be analysed as follows:\n\n* Descriptive statics (frequencies, percentages, and median responses)\n* Statistical tests (t-tests, ANOVA, correlation)\n\nSTAGE 2 INTERVIEWS: Data will be analysed using thematic analysis which will inform stages 3 and 4.\n\nSTAGE 3 JOINT DISCUSSIONS: Approximately 16 participants; a mix of all groups will attend a 2-hour joint event.\n\nSTAGE 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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke rehabilitation', 'Co-design', 'Adherence', 'Clinical trials'], 'conditions': ['Stroke', 'Rehabilitation', 'Co-design']}, 'referencesModule': {'references': [{'pmid': '25539950', 'type': 'RESULT', 'citation': 'Barac R, Stein S, Bruce B, Barwick M. Scoping review of toolkits as a knowledge translation strategy in health. BMC Med Inform Decis Mak. 2014 Dec 24;14:121. doi: 10.1186/s12911-014-0121-7.'}, {'pmid': '31426825', 'type': 'RESULT', 'citation': "Hempel S, O'Hanlon C, Lim YW, Danz M, Larkin J, Rubenstein L. Spread tools: a systematic review of components, uptake, and effectiveness of quality improvement toolkits. Implement Sci. 2019 Aug 19;14(1):83. doi: 10.1186/s13012-019-0929-8."}, {'pmid': '41195536', 'type': 'RESULT', 'citation': 'Logan A, Marsden J, Freeman J, Cork E, Kent B. Optimising adherence to inpatient rehabilitation trial protocols: A mixed-methods systematic review. Clin Trials. 2025 Dec;22(6):728-744. doi: 10.1177/17407745251358262. Epub 2025 Nov 6.'}, {'pmid': '22486599', 'type': 'RESULT', 'citation': 'Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x.'}, {'pmid': '32004440', 'type': 'RESULT', 'citation': 'Stinear CM, Lang CE, Zeiler S, Byblow WD. Advances and challenges in stroke rehabilitation. Lancet Neurol. 2020 Apr;19(4):348-360. doi: 10.1016/S1474-4422(19)30415-6. Epub 2020 Jan 28.'}], 'seeAlsoLinks': [{'url': 'https://stroke-rehab.org/', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': "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.\n\nPrevious 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.\n\nThe 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.\n\nToolkits 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.\n\nThis 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.\n\nBy 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.", 'detailedDescription': '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.\n\nA 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.\n\nToolkits 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.\n\nThe 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.\n\nThe investigators will consider potential barriers and solutions to implementation throughout to ensure successful adoption of a toolkit in future inpatient stroke rehabilitation trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke survivors, family member or friend of stroke survivor, stroke rehabilitation staff, healthcare leaders, stroke rehabilitation researchers, funders of stroke rehabilitation research.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Participants will be eligible if they meet the following criteria:\n\n8.1.1 Inclusion criteria stroke survivors\n\n* Adults (aged 18+) who have experienced a stroke. No time limit since stroke\n* Able to provide informed consent\n* Sufficient communication abilities (verbal or non-verbal, with or without support) to participate in co-design activities\n* Received inpatient stroke rehabilitation after their stroke\n* Has or has not previously participated in a stroke rehabilitation clinical trial during their hospital-based stroke rehabilitation\n* Willing to participate in co-design activities and share their perspectives.\n\n8.1.2 Inclusion criteria family member/friend of stroke survivor\n\n* Adults (aged 18+) who are a family member, friend, or informal caregiver of a stroke survivor.\n* Able and willing to provide informed consent.\n* Willing to participate in co-design activities and share their perspectives.\n\n8.1.3 Inclusion criteria stroke rehabilitation staff\n\n* Registered staff currently working in stroke rehabilitation who routinely prescribe and/or supporting stroke rehabilitation activities (e.g., physiotherapist, occupational therapist, rehabilitation nurses, rehabilitation physician)\n* ≥6 months of experience in hospital-based stroke rehabilitation settings\n* Employed in an organisation that provides NHS hospital-based stroke rehabilitation services\n* Willing to participate in co-design activities and share their perspectives.\n\n8.1.4 Inclusion criteria healthcare leaders (e.g., Managers, Administrators, Policy Makers)\n\n* Individuals who are accountable and responsible for the operational, clinical, and/or strategic delivery of stroke rehabilitation, rehabilitation and/or therapy services within a NHS hospital\n* Individuals working in an Integrated Care Board with rehabilitation and/or research in their portfolio\n* Experience in implementing/influencing stroke rehabilitation policy/service delivery\n* Willing to participate in co-design activities and share their perspectives.\n\n8.1.5 Inclusion criteria stroke rehabilitation researchers\n\n* Active researchers with experience in designing, conducting and evaluating stroke rehabilitation or physical rehabilitation research\n* Affiliated with academic or research institutions\n* Willing to participate in co-design activities and share their perspectives.\n\n8.1.6 Inclusion criteria for funders\n\n* Currently employed, contracted to, or formally affiliated with a research funding organisation that reviews, commissions or funds stroke rehabilitation research (e.g., NIHR, Stroke Association, research councils, medical research councils, professional bodies or research charities)\n* Direct involvement in decision-making, monitoring or governance of stroke rehabilitation research within the past two years\n* Experience with funding processes related to stroke rehabilitation, rehabilitation or clinical trial oversight\n\n8.2 Exclusion Criteria\n\nParticipants will not be eligible if they meet any the following criteria:\n\n8.2.1 Exclusion criteria for stroke survivors\n\n* Significant cognitive and/or communication impairment that preclude meaningful participation, even with support\n* Exhibiting aggression or other behaviour issues that put themselves and others at risk\n* Medical instability that would make participation unsafe or overly burdensome\n* Currently enrolled in another research study that could confound participation or data collection\n* Non-English speaking (research study does not offer language support).\n\n8.2.2 Exclusion criteria for family member/friend of stroke survivor\n\n* Not family member or friend of a stroke survivor\n* Significant emotional distress or trauma that would be exacerbated by participation.\n* Non-English speaking (research study does not offer language support).\n\n8.2.3 Exclusion criteria for stroke rehabilitation staff\n\n* Currently under disciplinary review or leave of absence.\n* ≤6 experience in NHS inpatient stroke rehabilitation\n* Inability to commit time to the study activities.\n\n8.2.4 Exclusion criteria for healthcare leaders (e.g., Managers, Administrators, Policy Makers)\n\n* Not in a leadership or decision-making role within an organisation that provides NHS inpatient stroke rehabilitation or rehabilitation/therapy services\n* Not working in an Integrated Care Board/System\n* No experience in implementing or influencing stroke rehabilitation policy or service delivery\n* Conflict of interest with study funders or researchers.\n\n8.2.5 Exclusion criteria for stroke rehabilitation researchers\n\n* No direct experience with stroke or rehabilitation research in the past two years.\n* No experience of hospital-based stroke or physical rehabilitation research in the past two years\n* Participation that would lead to conflicts of interest with the research team or funders.\n\n8.2.6 Exclusion criteria for funders\n\n* Not employed by or formally affiliated with a research funding organisation that reviews, commissions or funds stroke rehabilitation research (e.g., NIHR, Stroke Association, research councils, medical research councils, professional bodies or research charities)\n* No direct involvement in decision-making, monitoring or governance of stroke rehabilitation research within the past two years\n* Conflict of interest with the research team or institutions delivering this study'}, 'identificationModule': {'nctId': 'NCT07484958', 'briefTitle': 'Co-designing a Stroke Rehabilitation Trial Toolkit', 'organization': {'class': 'OTHER', 'fullName': 'University of Plymouth'}, 'officialTitle': 'Co-designing a Toolkit to Optimise Adherence to Inpatient Stroke Rehabilitation Trial Protocols', 'orgStudyIdInfo': {'id': 'Ethics Application 6320'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke survivors', 'description': 'Stroke survivors aged 18 years and over', 'interventionNames': ['Other: Co-designing a stroke rehabilitation toolkit']}, {'label': 'Stroke rehabilitation staff', 'description': 'Staff with more than 6 months experience of working in inpatient stroke rehabilitation, e.g., nurse, occupational therapist, physiotherapist, rehabilitation physician', 'interventionNames': ['Other: Co-designing a stroke rehabilitation toolkit']}, {'label': 'Healthcare leaders', 'description': 'Individuals who are accountable and responsible for the operational, clinical, and/or strategic delivery of stroke rehabilitation, rehabilitation and/or therapy services within a NHS hospital\n\n* Individuals working in an Integrated Care Board with rehabilitation and/or research in their portfolio\n* Experience in implementing/influencing stroke rehabilitation policy/service delivery', 'interventionNames': ['Other: Co-designing a stroke rehabilitation toolkit']}, {'label': 'Stroke rehabilitation researchers', 'description': 'Active researchers with experience in designing, conducting and evaluating stroke rehabilitation or physical rehabilitation research\n\n* Affiliated with academic or research institutions\n* Willing to participate in co-design activities and share their perspectives.', 'interventionNames': ['Other: Co-designing a stroke rehabilitation toolkit']}, {'label': 'Stroke rehabilitation funders', 'description': '* Currently employed, contracted to, or formally affiliated with a research funding organisation that reviews, commissions or funds stroke rehabilitation research (e.g., NIHR, Stroke Association, research councils, medical research councils, professional bodies or research charities)\n* Direct involvement in decision-making, monitoring or governance of stroke rehabilitation research within the past two years\n* Experience with funding processes related to stroke rehabilitation, rehabilitation or clinical trial oversight', 'interventionNames': ['Other: Co-designing a stroke rehabilitation toolkit']}, {'label': 'Family member or friend of stroke survivor', 'description': '* Adults (aged 18+) who are a family member, friend, or informal caregiver of a stroke survivor.\n* Able and willing to provide informed consent.\n* Willing to participate in co-design activities and share their perspectives.', 'interventionNames': ['Other: Co-designing a stroke rehabilitation toolkit']}], 'interventions': [{'name': 'Co-designing a stroke rehabilitation toolkit', 'type': 'OTHER', 'description': '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.\n\nSTAGE 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.\n\nSTAGE 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.\n\nSTAGE 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).\n\nSTAGE 5: CELEBRATION EVENT: showcase the co-designed outcomes, celebrate participant contributions, and share learning with wider stakeholders.', 'armGroupLabels': ['Family member or friend of stroke survivor', 'Healthcare leaders', 'Stroke rehabilitation funders', 'Stroke rehabilitation researchers', 'Stroke rehabilitation staff', 'Stroke survivors']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL4 6AB', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'University of Plymouth, Faculty of Health', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Jonathan Marsden, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Plymouth'}, {'name': 'Angie Logan, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Plymouth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Plymouth', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Devon and Exeter NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Rehabilitation', 'investigatorFullName': 'Jon Marsden', 'investigatorAffiliation': 'University of Plymouth'}}}}