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A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial

BACKGROUND: The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial [RCT] with an internal pilot phase. The ACE study incorporates a multi-level mixed methods process evaluation including a systems mapping approach and an economic ev...

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Autores principales: Stathi, Afroditi, Withall, Janet, Crone, Diane, Hawley-Hague, Helen, Playle, Rebecca, Frew, Emma, Fenton, Sally, Hillsdon, Melvyn, Pugh, Christopher, Todd, Chris, Jolly, Kate, Cavill, Nick, Western, Max, Roche, Sarah, Kirby, Nigel, Boulton, Elisabeth, Thompson, Janice, Chatwin, Katie, Davies, Amy, Szekeres, Zsofia, Greaves, Colin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10687817/
https://www.ncbi.nlm.nih.gov/pubmed/38031101
http://dx.doi.org/10.1186/s13063-023-07758-3
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author Stathi, Afroditi
Withall, Janet
Crone, Diane
Hawley-Hague, Helen
Playle, Rebecca
Frew, Emma
Fenton, Sally
Hillsdon, Melvyn
Pugh, Christopher
Todd, Chris
Jolly, Kate
Cavill, Nick
Western, Max
Roche, Sarah
Kirby, Nigel
Boulton, Elisabeth
Thompson, Janice
Chatwin, Katie
Davies, Amy
Szekeres, Zsofia
Greaves, Colin
author_facet Stathi, Afroditi
Withall, Janet
Crone, Diane
Hawley-Hague, Helen
Playle, Rebecca
Frew, Emma
Fenton, Sally
Hillsdon, Melvyn
Pugh, Christopher
Todd, Chris
Jolly, Kate
Cavill, Nick
Western, Max
Roche, Sarah
Kirby, Nigel
Boulton, Elisabeth
Thompson, Janice
Chatwin, Katie
Davies, Amy
Szekeres, Zsofia
Greaves, Colin
author_sort Stathi, Afroditi
collection PubMed
description BACKGROUND: The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial [RCT] with an internal pilot phase. The ACE study incorporates a multi-level mixed methods process evaluation including a systems mapping approach and an economic evaluation. ACE aims to test the effectiveness and cost-effectiveness of a peer-volunteer led active ageing intervention designed to support older adults at risk of mobility disability to become more physically and socially active within their communities and to reduce or reverse, the progression of functional limitations associated with ageing. METHODS/DESIGN: Community-dwelling, older adults aged 65 years and older (n = 515), at risk of mobility disability due to reduced lower limb physical functioning (Short Physical Performance Battery (SPPB) score of 4–9 inclusive) will be recruited. Participants will be randomised to receive either a minimal control intervention or ACE, a 6-month programme underpinned by behaviour change theory, whereby peer volunteers are paired with participants and offer them individually tailored support to engage them in local physical and social activities to improve lower limb mobility and increase their physical activity. Outcome data will be collected at baseline, 6, 12 and 18 months. The primary outcome analysis (difference in SPPB score at 18 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. DISCUSSION: ACE is the largest, pragmatic, community-based randomised controlled trial in the UK to target this high-risk segment of the older population by mobilising community resources (peer volunteers). A programme that can successfully engage this population in sufficient activity to improve strength, coordination, balance and social connections would have a major impact on sustaining health and independence. ACE is also the first study of its kind to conduct a full economic and comprehensive process evaluation of this type of community-based intervention. If effective and cost-effective, the ACE intervention has strong potential to be implemented widely in the UK and elsewhere. TRIAL REGISTRATION: ISRCTN, ISRCTN17660493. Registered on 30 September 2021. Trial Sponsor: University of Birmingham, Contact: Dr Birgit Whitman, Head of Research Governance and Integrity; Email: researchgovernance@contacts.bham.ac.uk. Protocol Version 5 22/07/22. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07758-3.
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spelling pubmed-106878172023-11-30 A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial Stathi, Afroditi Withall, Janet Crone, Diane Hawley-Hague, Helen Playle, Rebecca Frew, Emma Fenton, Sally Hillsdon, Melvyn Pugh, Christopher Todd, Chris Jolly, Kate Cavill, Nick Western, Max Roche, Sarah Kirby, Nigel Boulton, Elisabeth Thompson, Janice Chatwin, Katie Davies, Amy Szekeres, Zsofia Greaves, Colin Trials Study Protocol BACKGROUND: The Active Connected Engaged [ACE] study is a multi-centre, pragmatic, two-arm, parallel-group randomised controlled trial [RCT] with an internal pilot phase. The ACE study incorporates a multi-level mixed methods process evaluation including a systems mapping approach and an economic evaluation. ACE aims to test the effectiveness and cost-effectiveness of a peer-volunteer led active ageing intervention designed to support older adults at risk of mobility disability to become more physically and socially active within their communities and to reduce or reverse, the progression of functional limitations associated with ageing. METHODS/DESIGN: Community-dwelling, older adults aged 65 years and older (n = 515), at risk of mobility disability due to reduced lower limb physical functioning (Short Physical Performance Battery (SPPB) score of 4–9 inclusive) will be recruited. Participants will be randomised to receive either a minimal control intervention or ACE, a 6-month programme underpinned by behaviour change theory, whereby peer volunteers are paired with participants and offer them individually tailored support to engage them in local physical and social activities to improve lower limb mobility and increase their physical activity. Outcome data will be collected at baseline, 6, 12 and 18 months. The primary outcome analysis (difference in SPPB score at 18 months) will be undertaken blinded to group allocation. Primary comparative analyses will be on an intention-to-treat (ITT) basis with due emphasis placed on confidence intervals. DISCUSSION: ACE is the largest, pragmatic, community-based randomised controlled trial in the UK to target this high-risk segment of the older population by mobilising community resources (peer volunteers). A programme that can successfully engage this population in sufficient activity to improve strength, coordination, balance and social connections would have a major impact on sustaining health and independence. ACE is also the first study of its kind to conduct a full economic and comprehensive process evaluation of this type of community-based intervention. If effective and cost-effective, the ACE intervention has strong potential to be implemented widely in the UK and elsewhere. TRIAL REGISTRATION: ISRCTN, ISRCTN17660493. Registered on 30 September 2021. Trial Sponsor: University of Birmingham, Contact: Dr Birgit Whitman, Head of Research Governance and Integrity; Email: researchgovernance@contacts.bham.ac.uk. Protocol Version 5 22/07/22. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07758-3. BioMed Central 2023-11-29 /pmc/articles/PMC10687817/ /pubmed/38031101 http://dx.doi.org/10.1186/s13063-023-07758-3 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Stathi, Afroditi
Withall, Janet
Crone, Diane
Hawley-Hague, Helen
Playle, Rebecca
Frew, Emma
Fenton, Sally
Hillsdon, Melvyn
Pugh, Christopher
Todd, Chris
Jolly, Kate
Cavill, Nick
Western, Max
Roche, Sarah
Kirby, Nigel
Boulton, Elisabeth
Thompson, Janice
Chatwin, Katie
Davies, Amy
Szekeres, Zsofia
Greaves, Colin
A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial
title A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial
title_full A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial
title_fullStr A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial
title_full_unstemmed A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial
title_short A peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (Active, Connected, Engaged [ACE]): study protocol for a randomised controlled trial
title_sort peer-volunteer led active ageing programme to prevent decline in physical function in older people at risk of mobility disability (active, connected, engaged [ace]): study protocol for a randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10687817/
https://www.ncbi.nlm.nih.gov/pubmed/38031101
http://dx.doi.org/10.1186/s13063-023-07758-3
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