Evaluation of different recruitment and randomisation methods in a trial of general practitioner-led interventions to increase physical activity: a randomised controlled feasibility study with factorial design

Trials

Melvyn Hillsdon⁵  John L Campbell⁵  Rod S Taylor⁵  Caroline Huxley⁴  Susan Bryant²  Aidan Searle²  Tim A Holt⁶  Katrina M Turner²  Marie Murphy¹  Deborah J Sharp²  Margaret Thorogood⁴  Kate Stych³  Fiona C Warren⁵ 

[1] Sport & Exercise Sciences Research Institute, Jordanstown Campus, Shore Road, Newtownabbey, University of Ulster, BT37 0QB, UK;Centre for Academic Primary Care, School of Social and Community Medicine, Canynge Hall, 39 Whatley Road, University of Bristol, Bristol BS8 2PS, UK;Department of Sport and Health Sciences, University of Exeter, St Luke’s Campus, Heavitree Road, Exeter EX1 2LU, UK;Warwick Medical School, University of Warwick, Gibbet Hill Campus, Coventry CV4 7AL, UK;Primary Care Research Group, University of Exeter Medical School, St Luke’s Campus, Heavitree Road, Exeter EX1 2LU, UK;Department of Primary Care Health Sciences, Radcliff Observatory Quarter, Woodstock Road, Oxford University, Oxford OX2 6GG, UK

关键词: Clinical trials;    Complex interventions;    Physical activity;    Primary care research;   

Others  :  806806
DOI  :  10.1186/1745-6215-15-134

 received in 2013-07-01, accepted in 2014-03-28,  发布年份 2014

【 摘 要 】

Background

Interventions promoting physical activity by General Practitioners (GPs) lack a strong evidence base. Recruiting participants to trials in primary care is challenging. We investigated the feasibility of (i) delivering three interventions to promote physical activity in inactive participants and (ii) different methods of participant recruitment and randomised allocation.

Methods

We recruited general practices from Devon, Bristol and Coventry. We used a 2-by-2 factorial design for participant recruitment and randomisation. Recruitment strategies were either opportunistic (approaching patients attending their GP surgery) or systematic (selecting patients from practice lists and approaching them by letter). Randomisation strategies were either individual or by practice cluster. Feasibility outcomes included time taken to recruit the target number of participants within each practice. Participants were randomly allocated to one of three interventions: (i) written advice (control); (ii) brief GP advice (written advice plus GP advice on physical activity), and (iii) brief GP advice plus a pedometer to self-monitor physical activity during the trial. Participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity, and were instructed not to unseal the pedometer before the scheduled day of data collection. Participant level outcomes were reported descriptively and included the mean number of pedometer steps over a 7-day period, and European Quality of Life (EuroQoL)-5 dimensions (EQ-5D) scores, recorded at 12 weeks’ follow-up.

Results

We recruited 24 practices (12 using each recruitment method; 18 randomising by cluster, 6 randomising by individual participant), encompassing 131 participants. Opportunistic recruitment was associated with less time to target recruitment compared with systematic (mean difference (days) -54.9, 95% confidence interval (CI) -103.6; -6.2) but with greater loss to follow up (28.8% versus. 6.9%; mean difference 21.9% (95% CI 9.6%; 34.1%)). There were differences in the socio-demographic characteristics of participants according to recruitment method. There was no clear pattern of change in participant level outcomes from baseline to 12 weeks across the three arms.

Conclusions

Delivering and trialling GP-led interventions to promote physical activity is feasible, but trial design influences time to participant recruitment, participant withdrawal, and possibly, the socio-demographic characteristics of participants.

Trial registration number

ISRCTN73725618.

【 授权许可】

   
2014 Warren et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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