TY - JOUR
T1 - A 2x2 randomised factorial SWAT of the use of a pen and small, financial incentive to improve recruitment rates in a randomised controlled trial of yoga for older adults with multimorbidity
AU - Fairhurst, Caroline
AU - Roche, Jenny
AU - Bissell, Laura
AU - Hewitt, Catherine
AU - Hugill-Jones, Jess
AU - Howsam, Jenny
AU - Maturana, Camila
AU - Corbacho Martin, Belen
AU - Paul, Shirley-Anne
AU - Rose, Fi
AU - Torgerson, David
AU - Ward, Lesley
AU - Wiley, Laura
AU - Tew, Garry
N1 - Funding information: The GYY trial and SWATs were funded by the United Kingdom National Health Service (NHS) through the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, open call project number 17/94/36. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
PY - 2022/3/4
Y1 - 2022/3/4
N2 - Background: 2x2 factorial ‘study within a trial’ evaluating the effectiveness of including a pen and/or £5 with a postal recruitment pack to increase randomisation rates (primary outcome) into the host Gentle Years Yoga trial in older adults with multimorbidity.Methods: Secondary outcomes were the return, and time to return, of a screening form, and the cost per additional participant recruited. Binary data were analysed using logistic regression and time to return data using Cox proportional hazards regression. Results: 818 potential host trial participants were included. Between those sent a pen (n=409) and those not sent a pen (n=409), there was no evidence of a difference in the likelihood of being randomised (15 (3.7%) vs 11 (2.7%); OR 1.38, 95% CI 0.63 to 3.04), in returning a screening form (n=66 (16.1%) vs n=61 (14.9%); OR 1.10, 95% CI 0.75, 1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77, 1.55). There was evidence of improved screening return rates (77 (18.8%) vs 50 (12.2%); OR 1.67, 95% CI 1.13, 2.45) and time to return screening form (HR 1.56, 95% CI 1.09, 2.22) but not randomisation (14 (3.4%) vs 12 (2.9%); OR 1.18, 95% CI 0.54, 2.57) in those sent £5 (n=409) compared with those not sent £5 (n=409). No significant interaction effects between the interventions were observed. The cost per additional participant recruited was £32 for the pen and £1000 for the £5 incentive.Conclusion: Including a small, monetary incentive encouraged increased and faster response to the recruitment invitation but did not result in more participants being randomised into the host trial. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens are cheaper but did not provide evidence of benefit. Further studies may be required.
AB - Background: 2x2 factorial ‘study within a trial’ evaluating the effectiveness of including a pen and/or £5 with a postal recruitment pack to increase randomisation rates (primary outcome) into the host Gentle Years Yoga trial in older adults with multimorbidity.Methods: Secondary outcomes were the return, and time to return, of a screening form, and the cost per additional participant recruited. Binary data were analysed using logistic regression and time to return data using Cox proportional hazards regression. Results: 818 potential host trial participants were included. Between those sent a pen (n=409) and those not sent a pen (n=409), there was no evidence of a difference in the likelihood of being randomised (15 (3.7%) vs 11 (2.7%); OR 1.38, 95% CI 0.63 to 3.04), in returning a screening form (n=66 (16.1%) vs n=61 (14.9%); OR 1.10, 95% CI 0.75, 1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77, 1.55). There was evidence of improved screening return rates (77 (18.8%) vs 50 (12.2%); OR 1.67, 95% CI 1.13, 2.45) and time to return screening form (HR 1.56, 95% CI 1.09, 2.22) but not randomisation (14 (3.4%) vs 12 (2.9%); OR 1.18, 95% CI 0.54, 2.57) in those sent £5 (n=409) compared with those not sent £5 (n=409). No significant interaction effects between the interventions were observed. The cost per additional participant recruited was £32 for the pen and £1000 for the £5 incentive.Conclusion: Including a small, monetary incentive encouraged increased and faster response to the recruitment invitation but did not result in more participants being randomised into the host trial. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens are cheaper but did not provide evidence of benefit. Further studies may be required.
KW - study within a trial
KW - pen
KW - financial incentive
KW - recruitment
KW - factorial
KW - randomised controlled trial
KW - older people
KW - multimorbidity
U2 - 10.12688/f1000research.52164.2
DO - 10.12688/f1000research.52164.2
M3 - Article
SN - 2046-1402
VL - 10
SP - 1
EP - 18
JO - F1000Research
JF - F1000Research
M1 - 326
ER -