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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

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 hea...

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Autores principales: Airlie, Jennifer, Burton, Louisa-Jane, Copsey, Bethan, English, Coralie, Farrin, Amanda, Fitzsimons, Claire F, Holloway, Ivana, Horrocks, Judith, Johansson, Jessica Faye, Mead, Gillian, Moreau, Lauren A, Ozer, Seline, Patel, Anita, Yaziji, Nahel, Forster, Anne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10387637/
https://www.ncbi.nlm.nih.gov/pubmed/37518078
http://dx.doi.org/10.1136/bmjopen-2023-074607
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author Airlie, Jennifer
Burton, Louisa-Jane
Copsey, Bethan
English, Coralie
Farrin, Amanda
Fitzsimons, Claire F
Holloway, Ivana
Horrocks, Judith
Johansson, Jessica Faye
Mead, Gillian
Moreau, Lauren A
Ozer, Seline
Patel, Anita
Yaziji, Nahel
Forster, Anne
author_facet Airlie, Jennifer
Burton, Louisa-Jane
Copsey, Bethan
English, Coralie
Farrin, Amanda
Fitzsimons, Claire F
Holloway, Ivana
Horrocks, Judith
Johansson, Jessica Faye
Mead, Gillian
Moreau, Lauren A
Ozer, Seline
Patel, Anita
Yaziji, Nahel
Forster, Anne
author_sort Airlie, Jennifer
collection PubMed
description 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).
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spelling pubmed-103876372023-08-01 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 Airlie, Jennifer Burton, Louisa-Jane Copsey, Bethan English, Coralie Farrin, Amanda Fitzsimons, Claire F Holloway, Ivana Horrocks, Judith Johansson, Jessica Faye Mead, Gillian Moreau, Lauren A Ozer, Seline Patel, Anita Yaziji, Nahel Forster, Anne BMJ Open Rehabilitation Medicine 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). BMJ Publishing Group 2023-07-30 /pmc/articles/PMC10387637/ /pubmed/37518078 http://dx.doi.org/10.1136/bmjopen-2023-074607 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Rehabilitation Medicine
Airlie, Jennifer
Burton, Louisa-Jane
Copsey, Bethan
English, Coralie
Farrin, Amanda
Fitzsimons, Claire F
Holloway, Ivana
Horrocks, Judith
Johansson, Jessica Faye
Mead, Gillian
Moreau, Lauren A
Ozer, Seline
Patel, Anita
Yaziji, Nahel
Forster, Anne
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Rehabilitation Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10387637/
https://www.ncbi.nlm.nih.gov/pubmed/37518078
http://dx.doi.org/10.1136/bmjopen-2023-074607
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