Study within a trial 119: The effectiveness of a thank you card to improve trial follow up; a randomised study within a trial

TY - JOUR

T1 - Study within a trial 119

T2 - The effectiveness of a thank you card to improve trial follow up; a randomised study within a trial

AU - Arundel, Catherine Ellen

AU - Welch, Charlie

AU - Tharmanathan, Puvanendran

AU - Dias, Joseph

N1 - © The Author(s) 2024

PY - 2024/2/1

Y1 - 2024/2/1

N2 - BackgroundWith attrition common in randomised trials, strategies are needed to minimise this. Many retention strategies include ‘thanks’ elements however there is currently no evidence of the effectiveness of a ‘thank you’ intervention separate to other trial activity or information. This Study Within A Trial (SWAT) sought to assess if a thank you card increases completion of the host trial primary outcome.MethodsA two arm SWAT, using a 1:1 (intervention:control) allocation ratio, embedded within the DISC trial. The primary outcome was the difference in retention rate at 1 year post-treatment. Secondary outcomes were outcome data completeness, cost, and retention at 2 years post-treatment. Analyses were conducted using logistic regression adjusting for SWAT and host trial allocation.ResultsA total of 358 participants were randomised and included in the SWAT analyses. Completion of the 1-year outcome visit was 89.7% (n = 157) in the intervention group and 90.2% (165) in the control group (adjusted odds ratio (OR) 0.95, 95% CI 0.48 to 1.90, p = .89). There was no evidence of a difference in completeness of key outcome data (adjusted OR 1.84, 95% CI 0.71 to 4.73, p = .20) or retention at 2 years post treatment (adjusted OR 1.13, 95% CI 0.59 to 2.17, p = .72).ConclusionIt remains unclear if thank you cards increased the rate of primary outcome follow-up completion within the DISC trial. However, as the first evaluation of a distinct ‘thank you’ intervention for improving retention rates, further replications are required to determine effectiveness, ideally in populations other than older, male, Caucasians.

AB - BackgroundWith attrition common in randomised trials, strategies are needed to minimise this. Many retention strategies include ‘thanks’ elements however there is currently no evidence of the effectiveness of a ‘thank you’ intervention separate to other trial activity or information. This Study Within A Trial (SWAT) sought to assess if a thank you card increases completion of the host trial primary outcome.MethodsA two arm SWAT, using a 1:1 (intervention:control) allocation ratio, embedded within the DISC trial. The primary outcome was the difference in retention rate at 1 year post-treatment. Secondary outcomes were outcome data completeness, cost, and retention at 2 years post-treatment. Analyses were conducted using logistic regression adjusting for SWAT and host trial allocation.ResultsA total of 358 participants were randomised and included in the SWAT analyses. Completion of the 1-year outcome visit was 89.7% (n = 157) in the intervention group and 90.2% (165) in the control group (adjusted odds ratio (OR) 0.95, 95% CI 0.48 to 1.90, p = .89). There was no evidence of a difference in completeness of key outcome data (adjusted OR 1.84, 95% CI 0.71 to 4.73, p = .20) or retention at 2 years post treatment (adjusted OR 1.13, 95% CI 0.59 to 2.17, p = .72).ConclusionIt remains unclear if thank you cards increased the rate of primary outcome follow-up completion within the DISC trial. However, as the first evaluation of a distinct ‘thank you’ intervention for improving retention rates, further replications are required to determine effectiveness, ideally in populations other than older, male, Caucasians.

U2 - 10.1177/26320843241229934

DO - 10.1177/26320843241229934

M3 - Article

SN - 2632-0843

JO - Research Methods in Medicine & Health Sciences

JF - Research Methods in Medicine & Health Sciences

ER -