The Heartline Experience: Achieving Long-Term Participant Engagement in Digital Health Technology Trials

Area of Science:

• Digital Health
• Cardiology
• Clinical Research

Background:

• Digital health technologies offer potential for improved clinical research efficiency and participant diversity.
• However, challenges exist in maintaining long-term participant engagement with these technologies.

Purpose of the Study:

• To evaluate the impact of a mobile app-based engagement program on atrial fibrillation (AF) diagnosis, treatment, and outcomes.
• The study focused on U.S. participants aged 65 years and older using Apple Watch features like Irregular Rhythm Notification (IRN) and electrocardiogram.

Main Methods:

• Participants were randomized 3:1 to a watch group or a control group, stratified by prevalent AF.
• A custom app facilitated enrollment, post-IRN follow-up, and electronic patient-reported outcome (ePRO) collection.
• Behavioral science principles, including human-centered design, health education, and incentives, were used to enhance engagement.

Main Results:

• Out of 34,244 enrolled participants, 94% initiated the program.
• Sustained high engagement was observed: 93% weekly engagement at 1 year and 86% at 2 years.
• Electronic patient-reported outcome completion rates were 82% at 1 year and 76% at 2 years.

Conclusions:

• The Heartline Study achieved high and sustained adherence over two years through a mobile app-based engagement program.
• Older adults successfully submitted study information remotely and reported high satisfaction.
• This demonstrates the feasibility of digital health tools for long-term engagement in clinical research for this demographic.