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Introduction: Stroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB ('Get Set Go') will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes., Methods and Analysis: This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model., Ethics and Dissemination: The study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations., Trial Registration Number: ISRCTN82280581., Competing Interests: Competing interests: AFo, AFa, CE, CFF, GM and DJC are coinvestigators on the grant funding this work therefore are partially supported by the National Institute for Health and Social Care Research (NIHR) (grant number RP-PG-0615-20019). AFo has received additional research grant support from NIHR through the following funding streams: senior Investigator award, Health Technology Assessment (HTA) and Health and Social Care Delivery Research (HS&DR). AFo has previously received support from the Stroke Association to attend the UK stroke forum and received payment from the National Institute for Health (USA) for panel membership (2021, 2022). AFo is currently the chair/a member of programme steering committees for NIHR research programmes (grant reference numbers: NIHR 202339, NIHR 202020) and has served on the following panels: NIHR Doctoral Fellowships, NIHR senior investigators committee (2019/20), NIHR HS&DR committee (2016–2018) and Stroke Association Funding. CE has received grant funding from the Netherlands Organisation for Scientific Research (NOW) Taskforce for Applied Research (SIA RAAK) for work in a similar area (ie, sitting less and moving more after stroke) and is a non-executive director representing interests of Research and Chair of Research Advisory Committee for the Stroke Foundation of Australia (unpaid). CFF is a coinvestigator/collaborator on other grants on the topic of sedentary behaviour/physical activity and is therefore partially supported by grant funding received from the University of Edinburgh and the Irish Health Board. CE has previously been supported to conduct work in a similar area by grant funding received from the Chief Scientist Office of the Scottish Government, Medical Research Council Public Health Intervention Development award and the University of Edinburgh. JFJ, LAM, RS, RM, JA, SO and DJC report no competing interests related to the manuscript., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention ('Get Set Go') was developed. A pragmatic definitive trial to evaluate Get Set Go was planned; however, due to the unprecedented effects of the COVID-19 pandemic on National Health Service (NHS) services this study was reduced in size and scope to become an external pilot trial. We report the protocol for this external pilot trial, which aims to undertake a preliminary exploration of whether Get Set Go is likely to improve ability to complete extended activities of daily living in the first year post-stroke and inform future trial designs in stroke rehabilitation., Methods and Analysis: This study is a pragmatic, multicentre, two-arm, external pilot cluster randomised controlled trial with embedded process and economic evaluations. UK-based stroke services will be randomised 1:1 to the intervention (usual care plus Get Set Go) or control (usual care) arm. Fifteen stroke services will recruit 300-400 stroke inpatient and carer participants, with follow-up at 6, 12 and 24 months. The proposed primary endpoint is stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months. Endpoint analyses will be exploratory and provide preliminary estimates of intervention effect. The process evaluation will provide valuable information on intervention fidelity, acceptability and how it can be optimised., Ethics and Dissemination: The study has been approved by Yorkshire and The Humber - Bradford-Leeds Research Ethics Committee (Ref: 19/YH/0403). Results will be disseminated through journal publications and conference presentations., Trial Registration Number: This trial was registered prospectively on 01 April 2020 (ISRCTN ref: ISRCTN82280581)., Competing Interests: Competing interests: AFo has received additional research grant support from NIHR through the following funding streams: Senior Investigator award, Health Technology Assessment and Health and Social Care Delivery Research (HS&DR). AFo has previously received support from the Stroke Association to attend the UK stroke forum and received payment from the National Institute for Health (USA) for panel membership (2021 and 2022). AFo is currently the chair/a member of the programme steering committees for NIHR research programmes (Grant reference numbers: NIHR 202339 and NIHR 202020) and has served on the following panels: NIHR Doctoral Fellowships, NIHR senior investigators committee (2019/2020), NIHR HS&DR committee (2016–2018) and Stroke Association Funding. CE has received grant funding from the Netherlands Organisation for Scientific Research (NOW) Taskforce for Applied Research (SIA RAAK) for work in a similar area (ie, sitting less and moving more after stroke) and is a non-executive Director representing interests of Research and Chair of Research Advisory Committee for the Stroke Foundation of Australia (unpaid). CFF is a co-investigator/collaborator on other grants on the topic of sedentary behaviour/physical activity and is therefore partially supported by grant funding received from the University of Edinburgh and the Irish Health Board. CE has previously been supported to conduct work in a similar area by grant funding received from the Chief Scientist Office of the Scottish Government, Medical Research Council Public Health Intervention Development award and the University of Edinburgh., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: Despite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-based and replicable longer term care strategy. The developed complex intervention (named New Start), which includes needs identification, exploration of social networks and components of problem solving and self-management, was designed to improve quality of life by addressing unmet needs and increasing participation., Methods/design: A multicentre, cluster randomised controlled feasibility trial designed to inform the design of a possible future definitive cluster randomised controlled trial (cRCT) and explore the potential clinical and cost-effectiveness of New Start. Ten stroke services across the UK will be randomised on a 1:1 basis either to implement New Start or continue with usual care only. New Start will be delivered by trained facilitators and will be offered to all stroke survivors within the services allocated to the intervention arm. Stroke survivors will be eligible for the trial if they are 4-6 months post-stroke and residing in the community. Carers (if available) will also be invited to take part. Invitation to participate will be initiated by post and outcome measures will be collected via postal questionnaires at 3, 6 and 9 months after recruitment. Outcome data relating to perceived health and disability, wellbeing and quality of life as well as unmet needs will be collected. A 'study within a trial' (SWAT) is planned to determine the most acceptable format in which to provide the postal questionnaires. Details of health and social care service usage will also be collected to inform the economic evaluation. The feasibility of recruiting services and stroke survivors to the trial and of collecting postal outcomes will be assessed and the potential for effectiveness will be investigated. An embedded process evaluation (reported separately) will assess implementation fidelity and explore and clarify causal assumptions regarding implementation., Discussion: This feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention., Trial Registration: ISRCTN38920246 . Registered 22 June 2016.