RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations.

Autor:	Airlie J; Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK jennifer.airlie@bthft.nhs.uk., Burton LJ; Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK., Copsey B; Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, UK., English C; School of Health Sciences, The University of Newcastle, Newcastle, New South Wales, Australia.; Heart and Stroke Research Program, The University of Newcastle Hunter Medical Research Institute, Newcastle, New South Wales, Australia., Farrin A; Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, UK., Fitzsimons CF; Physical Activity for Health and Research Centre, Institute for Sport Physical Education and Health Sciences, University of Edinburgh, Edinburgh, UK., Holloway I; Institute of Medical Psychology and Medical Sociology, University Medical Center Göttingen, Waldweg, Göttingen, Germany., Horrocks J; Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, UK., Johansson JF; Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.; Academic Unit for Ageing and Stroke Research, Leeds Institute of Health Sciences, University of Leeds, Leeds, West Yorkshire, UK., Mead G; Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK., Moreau LA; Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, UK., Ozer S; Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK., Patel A; Anita Patel Health Economics Consulting Ltd, London, UK., Yaziji N; Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Forster A; Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.; Academic Unit for Ageing and Stroke Research, Leeds Institute of Health Sciences, University of Leeds, Leeds, West Yorkshire, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Jul 30; Vol. 13 (7), pp. e074607. Date of Electronic Publication: 2023 Jul 30.
DOI:	10.1136/bmjopen-2023-074607
Abstrakt:	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.)
Databáze:	MEDLINE
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