Augmenting Engagement in Decentralized Clinical Trials for Atrial Fibrillation: Development and Implementation of a...

Area of Science:

• Cardiovascular Medicine
• Digital Health
• Clinical Trial Methodology

Background:

• Atrial fibrillation (AF) management requires long-term patient adherence to medications and self-monitoring.
• Clinical trials for AF often lack diversity in sex, race, ethnicity, and rural residence, limiting generalizability.
• Digital technology and remote strategies can improve recruitment of underrepresented populations in clinical trials.

Purpose of the Study:

• To summarize a research program's architecture designed to enhance geographic and demographic diversity in mobile health trials.
• To improve medication adherence in patients with atrial fibrillation through remote methods.

Main Methods:

• Developed a remote recruitment and assessment program for two National Institutes of Health-funded randomized clinical trials in AF patients.
• Utilized smartphone-based relational agents to test effectiveness on oral anticoagulation adherence.
• Employed remote methods (mail, telephone) for consent, randomization, training, and retention, accommodating varying health and digital literacy levels.

Main Results:

• Enrolled 513 participants, exceeding recruitment goals for rural and metropolitan populations.
• Achieved significant diversity: 62% women, 31% underrepresented minorities in the metropolitan study.
• Demonstrated high retention (over 89% at 12 months) and participant engagement with the mobile health intervention.

Conclusions:

• Successfully developed and implemented a programmatic architecture for remote clinical trials.
• Enhanced trial diversity and composition, offering an innovative mobile health intervention for AF medication adherence.
• Provided a model for improved recruitment and engagement of diverse participants in cardiovascular trials.