Increasing Retention in a Large-Scale Decentralized Clinical Trial: Learnings From the COVID-RED Trial

Area of Science:

• Clinical Trials
• Digital Health
• Infectious Disease Research

Background:

• Decentralized clinical trials (DCTs) offer novel approaches to data collection and participant engagement.
• Maintaining participant retention is crucial for the success and validity of large-scale DCTs, particularly in rapid response scenarios like the COVID-19 pandemic.
• Wearable devices and mobile applications present opportunities for remote monitoring and data acquisition in DCTs.

Purpose of the Study:

• To detail the retention strategies employed in a COVID-19 rapid early detection trial using wearable technology.
• To analyze study retention rates and identify key determinants of participant discontinuation.
• To provide actionable insights for optimizing retention in future decentralized clinical trials.

Main Methods:

• The study involved 17,825 participants using a wearable device and mobile app for SARS-CoV-2 detection.
• Retention strategies included general and personalized engagement activities.
• Multivariable logistic regression identified discontinuation predictors, with insights informing targeted telephone interventions.

Main Results:

• An 80.4% retention rate was achieved at 6 months, with 68.5% completing the trial.
• Age, employment, living situation, and vaccination status predicted discontinuation.
• Targeted calls to vaccinated pensioners reduced their dropout rate by 11.4%.

Conclusions:

• Innovative, data-driven retention strategies are effective in large decentralized clinical trials.
• Understanding participant characteristics and employing tailored interventions can significantly improve study retention.
• These findings offer a framework for designing successful retention plans in future DCTs.