Racial and Ethnic Representation and Study Engagement in a Siteless Digital Clinical Trial Using a Smartwatch: Findings From the Apple Heart Study

Mayo Clinic Proceedings. Digital health Pub Date : 2025-06-03 DOI:10.1016/j.mcpdig.2025.100232

Kaylin T. Nguyen MD , Jingzhi Yu BA , Haley Hedlin PhD , Adam T. Phillips MD , Sumbul Desai MD , Lauren Cheung MD , Peter R. Kowey MD , Sneha S. Jain MD , John S. Rumsfeld MD, PhD , Andrea M. Russo MD , Christopher B. Granger MD , Mellanie True Hills BS , Manisha Desai PhD , Kenneth W. Mahaffey MD , Mintu P. Turakhia MD, MAS , Marco V. Perez MD

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Abstract

Objective

To evaluate differences in study engagement in diverse racial/ethnic groups that have been significantly underrepresented in atrial fibrillation and digital clinical trials.

Patients and Methods

This was a secondary analysis of participants from the Apple Heart Study, a prospective, siteless, single-arm pragmatic clinical trial from November 29, 2017, to January 31, 2019. Black, Hispanic, Asian, and White participants were monitored using an irregular rhythm notification algorithm designed to detect atrial fibrillation on a smartwatch. Logistic regression was performed to evaluate the relationship between race/ethnicity and completion of the first study visit after an irregular rhythm notification, adjusting for demographic characteristics and comorbidities.

Results

Of the 419,297 participants, 393,396 (93.8%) individuals self-identified as White, Black, Hispanic, or Asian. Overall, participants were 57% men and had a mean (SD) age of 41 (13) years. Among 2044 (0.52%) participants who received an irregular rhythm notification, non-White participants had lower odds of completing the initial virtual study visit compared with White participants (Black: OR, 0.61; 95% CI, 0.39-0.94; Hispanic: OR, 0.62; 95% CI, 0.40-0.95; Asian: OR, 0.40; 95% CI, 0.23-0.66) after multivariate adjustment. Among those who completed the initial study visit, there was no statistically significant difference in the odds of returning the electrocardiogram patch in the non-White groups compared with that of the White group.

Conclusion

Despite successful recruitment of racially and ethnically diverse participants, there were differences in subsequent engagement by non-White compared with that by White participants. Equitable representation and engagement of diverse racial and ethnic groups in digital clinical studies requires further study.

Trial Registration

Clinicaltrials.gov Identifier: NCT03335800

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使用智能手表的无现场数字临床试验中的种族和民族代表性和研究参与：来自苹果心脏研究的发现

目的评估不同种族/民族在房颤和数字化临床试验中代表性明显不足的研究参与的差异。患者和方法：这是对苹果心脏研究参与者的二次分析，该研究是一项前瞻性、无部位、单臂实用临床试验，于2017年11月29日至2019年1月31日进行。黑人、西班牙裔、亚洲人和白人参与者使用一种不规则节律通知算法进行监测，该算法设计用于在智能手表上检测心房颤动。采用逻辑回归来评估种族/民族与节律不规律通知后首次研究访视完成程度之间的关系，调整人口统计学特征和合并症。结果在419,297名参与者中，有393,396人（93.8%）自认为是白人、黑人、西班牙裔或亚洲人。总体而言，参与者中57%为男性，平均（SD）年龄为41（13）岁。在2044名（0.52%）收到不规则节律通知的参与者中，与白人参与者相比，非白人参与者完成初始虚拟研究访问的几率较低(黑人：OR， 0.61；95% ci, 0.39-0.94；西班牙裔：OR， 0.62；95% ci, 0.40-0.95；亚洲：OR， 0.40；95% CI, 0.23-0.66)。在完成最初研究访问的患者中，与白人组相比，非白人组归还心电图贴片的几率没有统计学上的显著差异。结论尽管成功招募了不同种族和民族的参与者，但非白人参与者的后续参与程度与白人参与者相比存在差异。数字临床研究中不同种族和民族群体的公平代表和参与需要进一步研究。临床试验注册号：NCT03335800

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Mayo Clinic Proceedings. Digital health Medicine and Dentistry (General), Health Informatics, Public Health and Health Policy

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47 days