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Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial

BACKGROUND: Failure to recruit to target or schedule is common in randomized controlled trials (RCTs). Innovative interventions are not always fully developed before being tested, and maintenance of fidelity to the intervention during trials can be problematic. Missing data can compromise analyses,...

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Autores principales: Stevens, Zoe, Carpenter, Hannah, Gawler, Sheena, Belcher, Carolyn, Haworth, Deborah, Kendrick, Denise, Morris, Richard, Masud, Tahir, Skelton, Dawn A, Iliffe, Steve
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3707765/
https://www.ncbi.nlm.nih.gov/pubmed/23815878
http://dx.doi.org/10.1186/1745-6215-14-192
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author Stevens, Zoe
Carpenter, Hannah
Gawler, Sheena
Belcher, Carolyn
Haworth, Deborah
Kendrick, Denise
Morris, Richard
Masud, Tahir
Skelton, Dawn A
Iliffe, Steve
author_facet Stevens, Zoe
Carpenter, Hannah
Gawler, Sheena
Belcher, Carolyn
Haworth, Deborah
Kendrick, Denise
Morris, Richard
Masud, Tahir
Skelton, Dawn A
Iliffe, Steve
author_sort Stevens, Zoe
collection PubMed
description BACKGROUND: Failure to recruit to target or schedule is common in randomized controlled trials (RCTs). Innovative interventions are not always fully developed before being tested, and maintenance of fidelity to the intervention during trials can be problematic. Missing data can compromise analyses, and inaccurate capture of risks to participants can influence reporting of intervention harms and benefits. In this paper we describe how challenges of recruitment and retention of participants, standardisation and quality control of interventions and capture of adverse events were overcome in the ProAct65+ cluster RCT. This trial compared class-based and home-based exercise with usual care in people aged 65 years and over, recruited through general practice. The home-based exercise participants were supported by Peer Mentors. RESULTS: (1) Organisational factors, including room availability in general practices, slowed participant recruitment so the recruitment period was extended and the number invited to participate increased. (2) Telephone pre-screening was introduced to exclude potential participants who were already very active and those who were frequent fallers. (3) Recruitment of volunteer peer mentors was difficult and time consuming and their acceptable case load less than expected. Lowering the age limit for peer mentors and reducing their contact schedule with participants did not improve recruitment. (4) Fidelity to the group intervention was optimised by introducing quality assurance observation of classes by experienced exercise instructors. (5) Diaries were used to capture data on falls, service use and other exercise-related costs, but completion was variable so their frequency was reduced. (6) Classification of adverse events differed between research sites so all events were assessed by both sites and discrepancies discussed. CONCLUSIONS: Recruitment rates for trials in general practice may be limited by organisational factors and longer recruitment periods should be allowed for. Exercise studies may be attractive to those who least need them; additional screening measures can be employed to avoid assessment of ineligible participants. Enrolment of peer mentors for intervention support is challenging and needs to be separately tested for feasibility. Standardisation of exercise interventions is problematic when exercise programmes are tailored to participants’ capabilities; quality assurance observations may assure fidelity of the intervention. Data collection by diaries can be burdensome to participants, resulting in variable and incomplete data capture; compromises in completion frequency may reduce missing data. Risk assessments are essential in exercise promotion studies, but categorisation of risks can vary between assessors; methods for their standardisation can be developed. TRIAL REGISTRATION: ISRCTN43453770
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spelling pubmed-37077652013-07-11 Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial Stevens, Zoe Carpenter, Hannah Gawler, Sheena Belcher, Carolyn Haworth, Deborah Kendrick, Denise Morris, Richard Masud, Tahir Skelton, Dawn A Iliffe, Steve Trials Update BACKGROUND: Failure to recruit to target or schedule is common in randomized controlled trials (RCTs). Innovative interventions are not always fully developed before being tested, and maintenance of fidelity to the intervention during trials can be problematic. Missing data can compromise analyses, and inaccurate capture of risks to participants can influence reporting of intervention harms and benefits. In this paper we describe how challenges of recruitment and retention of participants, standardisation and quality control of interventions and capture of adverse events were overcome in the ProAct65+ cluster RCT. This trial compared class-based and home-based exercise with usual care in people aged 65 years and over, recruited through general practice. The home-based exercise participants were supported by Peer Mentors. RESULTS: (1) Organisational factors, including room availability in general practices, slowed participant recruitment so the recruitment period was extended and the number invited to participate increased. (2) Telephone pre-screening was introduced to exclude potential participants who were already very active and those who were frequent fallers. (3) Recruitment of volunteer peer mentors was difficult and time consuming and their acceptable case load less than expected. Lowering the age limit for peer mentors and reducing their contact schedule with participants did not improve recruitment. (4) Fidelity to the group intervention was optimised by introducing quality assurance observation of classes by experienced exercise instructors. (5) Diaries were used to capture data on falls, service use and other exercise-related costs, but completion was variable so their frequency was reduced. (6) Classification of adverse events differed between research sites so all events were assessed by both sites and discrepancies discussed. CONCLUSIONS: Recruitment rates for trials in general practice may be limited by organisational factors and longer recruitment periods should be allowed for. Exercise studies may be attractive to those who least need them; additional screening measures can be employed to avoid assessment of ineligible participants. Enrolment of peer mentors for intervention support is challenging and needs to be separately tested for feasibility. Standardisation of exercise interventions is problematic when exercise programmes are tailored to participants’ capabilities; quality assurance observations may assure fidelity of the intervention. Data collection by diaries can be burdensome to participants, resulting in variable and incomplete data capture; compromises in completion frequency may reduce missing data. Risk assessments are essential in exercise promotion studies, but categorisation of risks can vary between assessors; methods for their standardisation can be developed. TRIAL REGISTRATION: ISRCTN43453770 BioMed Central 2013-07-01 /pmc/articles/PMC3707765/ /pubmed/23815878 http://dx.doi.org/10.1186/1745-6215-14-192 Text en Copyright © 2013 Stevens et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Update
Stevens, Zoe
Carpenter, Hannah
Gawler, Sheena
Belcher, Carolyn
Haworth, Deborah
Kendrick, Denise
Morris, Richard
Masud, Tahir
Skelton, Dawn A
Iliffe, Steve
Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial
title Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial
title_full Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial
title_fullStr Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial
title_full_unstemmed Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial
title_short Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial
title_sort lessons learnt during a complex, multicentre cluster randomised controlled trial: the proact65+ trial
topic Update
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3707765/
https://www.ncbi.nlm.nih.gov/pubmed/23815878
http://dx.doi.org/10.1186/1745-6215-14-192
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