Racial and Ethnic Representation and Study Engagement in a Siteless Digital Clinical Trial Using a Smartwatch:...

Area of Science:

• Digital health
• Cardiovascular research
• Clinical trial diversity

Background:

• Racial and ethnic minorities are underrepresented in clinical trials.
• Digital clinical trials offer opportunities to increase participant diversity.
• Atrial fibrillation research has historically lacked diverse representation.

Purpose of the Study:

• To evaluate study engagement differences across racial/ethnic groups in a digital atrial fibrillation trial.
• To identify barriers to participation for underrepresented minorities in digital health studies.
• To inform strategies for improving diversity in digital clinical research.

Main Methods:

• Secondary analysis of the Apple Heart Study (NCT03335800).
• Prospective, siteless, single-arm pragmatic trial using smartwatch irregular rhythm notifications.
• Logistic regression to assess race/ethnicity and virtual study visit completion, adjusting for covariates.

Main Results:

• Non-White participants (Black, Hispanic, Asian) had lower odds of completing the initial virtual study visit compared to White participants.
• Odds ratios for visit completion were: Black (0.61), Hispanic (0.62), and Asian (0.40).
• No significant difference in electrocardiogram patch return rates between non-White and White participants after initial visit completion.

Conclusions:

• Despite diverse recruitment, disparities in subsequent engagement exist in digital clinical studies.
• Differences in engagement highlight the need for further investigation into equitable participation.
• Strategies to enhance engagement of diverse populations in digital health research are crucial.