Long-term follow-up of clinical trial participants: Predictors of post-trial response in older subjects

Abstract

Background and objectiveThe post-trial follow-up (PTFU) phase of a clinical trial can provide important information on maintenance of intervention effects. However, approaches for the PTFU are rarely described. This short communication describes our process for PTFU that involved recontacting older subjects who participated in a clinical trial between 2015 and 2019. We also describe correlates of response to our PTFU survey. MethodsThe parent clinical trial aimed to reduce depression symptoms among older spousally-bereaved adults. We attempted to recontact our sample during the early stages of the COVID-19 pandemic. Using logistic regression, we examined physical health, depression symptoms, cognitive status, and disability as correlates of participant response to the PTFU phase. ResultsForty-two percent of participants responded to the PTFU survey. Disability – or the inability to participate in major life tasks and social roles - was significantly associated with response. Participants with greater disability were less likely to respond to the PTFU survey. ConclusionsOlder adults with disabilities may need alternative and supportive strategies for engaging in the PTFU phase.Clinical Trials Registration: NCT02631291