Abstract Body: Background: A successful clinical trial requires retention as well as recruitment of subjects. Exploring reasons for dropout can provide insights for application to the design and methods of future long-term stroke trials. The aim of this study is to understand reasons for dropout in a stroke trial.
Methods: The C3FIT (Coordinated, Collaborative, Comprehensive Family-Based, Integrated, Technology-enabled Care) (NCT04000971) is a multicenter, randomized, single-blinded, Phase III, cluster randomized trial assessing if an Integrated Stroke Practice Unit (ISPU) system of care with 12 monthly home/virtual visits will improve quality of life for stroke survivors compared to standard of care. There are 22 Comprehensive/Primary Stroke Center (CSC/PSC) sites; 12 ISPU and 10 CSC/PSC arm. The ISPU arm provides coordinated care by a nurse and lay health educator. The control arm receives standard of care at 3, 6, and 12 months. Enrollment began 03.03.2020 and monthly visits will end 10.31.2024. Participants who dropped out prior to the 12-month follow-up were asked to give reasons that were classified into themes.
Results: Of the 1,196 participants enrolled, 67 died, 85 were lost to follow-up, 5 moved away. A total of 105 withdrew, 14 left for other reasons, and 91 dropped out. Those who dropped out did not give a reason (n=52). Of those who did, the most common reason for dropping out was “feeling overwhelmed” (n=27), describing reasons as overwhelmed due to time commitments (n=8) or health reasons (n=14). Two participants reported competing external priorities, while 12 provided various reasons for dropping out, and 12 felt the study did not meet their expectations, Table 1.
Conclusions: The majority of participants who dropped out of this trial did not provide a reason. Information from those who did provide suggestions indicates improvements could be made in communicating study expectations during the informed consent process along with strategies for minimizing study burden. Protocols should implement a plan to capture reasons for dropout from conversations with participants. Such data could assist personnel across multiple sites in supporting participants to continue in a trial and identify potential study changes to facilitate continued involvement. This information could also assist in recruitment and retention strategies for future clinical trials. Further research is needed to fully address stroke survivors’ reasons for prematurely leaving a clinical trial.