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. 2025 Jun 3;3(3):100232.
doi: 10.1016/j.mcpdig.2025.100232. eCollection 2025 Sep.

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

Kaylin T Nguyen  1 , Jingzhi Yu  2 , Haley Hedlin  2 , Adam T Phillips  3 , Sumbul Desai  3 , Lauren Cheung  3 , Peter R Kowey  4 , Sneha S Jain  5 , John S Rumsfeld  6 , Andrea M Russo  7 , Christopher B Granger  8 , Mellanie True Hills  9 , Manisha Desai  2 , Kenneth W Mahaffey  5   10 , Mintu P Turakhia  5 , Marco V Perez  5
Affiliations

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

Kaylin T Nguyen et al. Mayo Clin Proc Digit Health. .

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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Conflict of interest statement

Drs Phillips, Desai, and Cheung report employment by Apple Inc. Dr Russo reports grants from Abbott, Bayer, Boston Scientific, Medtronic, and Novartis; consulting fees from Abbott, Bayer, Biosense Webster, Biotronik, Boston Scientific, Medtronic, Orchestra BioMed, and PaceMate; honorarium payments from Abbott, BMS-Pfizer, Boston Scientific, Medtronic, and Sanofi; participation in data safety monitoring board of Biosense Webster and Medtronic. Dr Kowey reports serving on the executive committee of the Apple Heart Study. Dr Jain has received grants from Stanford University and American Heart Association; consulting fees from Bristol Myers Squibb, ARTIS Ventures, and Broadview Ventures; and travel support form Janssen and Janssen and reports participation in the data safety monitoring board of Bristol Myers Squibb; leadership roles in ACC Healthcare Innovation Section; and stock or stock options in Microsoft, Merck, Disney, and Exxon, outside of the submitted work. Dr Granger reports grants from Alnylam, Boehringer Ingelheim, Bristol Myers Squibb, FDA, Janssen, Lilly, Novartis, Pfizer, Philips, and Roche; consulting fees and honoraria from Abbvie, Abiomed, Amgen, Alnylam Pharmaceuticals, Anthos, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardionomic, Cadrenal, CeleCore Therapueutics, HengRui, Janssen, Medscape, Medtronic Inc, Merck, NIH, NephroSynergy, Novo Nordisk, Novartis, Pfizer, Philips, REATA, Roche, and Veralox; participation in data safety board of Bayer, Novartis, Novo Nordisk, Veralox, Cardionomics, Janssen, and Merck; and stock or stock options in Tenac.io. Ms Hills reported being an employee of StopAfib.org, True Hills Inc, and American Foundation for Women’s Health, which receive funds from industry, but she does not personally benefit. Dr Mahaffey reports grants from ACC, AHA, Apple Inc, Bayer, California Institute Regenerative Medicine, CSL Behring, Cytokinetics, Eidos, Element, Ferring, Gilead, Google (Verily), Idorsia, Johnson & Johnson, Luitpold, Myovant, Novartis, PAC-12, Precordior, Sanifit, and St. Jude Medical; consulting fees from Applied Therapeutics, Bayer, BMS, BridgeBio, Eli Lilly, Elsevier, Fosun Pharma, Human, Johnson & Johnson, Moderna, Myokardia, Novartis, Novo Nordisk, Phasebio, Portola, Quidel, Scleroderma Foundation, and Theravance; honoraria from CSL Behring; and stock or stock options in Human, Medeloop, Precordior, and Regencor. Dr Turakhia reported receiving research grants from Bristol Myers Squibb, American Heart Association, Bayer, Gilead Sciences, and the Food and Drug Administration and consulting fees from Medtronic, Pfizer, Johnson & Johnson. Equity from iRhythm, Connect America, Forward, Evidently, PocketRN, AliveCor, Hippocratic.ai, Nuraxi Health. Dr Turakhia is an employee and corporate officer of iRhythm Technologies Inc, but this work was not supported by the company and was performed exclusively in his academic role. Dr. Turakhia also reports grants from Bristol Myers Squibb, American Heart Association, Bayer AG, Gilead Sciences, and Food and Drug Administration; personal fees from Medtronic, Pfizer, Johnson & Johnson, AliveCor, and iRhythm; and other fees from AliveCor, Evidently, Forward, Connect America, PocketRN, and iRhythm, outside the submitted work. Dr Perez reports consulting fees Apple Inc, QALY, Boston Scientific, and Johnson and Johnson; testimonial payments from Apple. The other authors report no competing interests.

Figures

Figure 1
Figure 1
Unadjusted representation in study components, by race/ethnic group. ECG, electrocardiogram.
Figure 2
Figure 2
Adjusted odds ratio for participation in the following study procedures: (A) study visit 1 (n=2044), (B) return electrocardiogram (ECG) patch (n=844), (C) 90-day survey (n=2044), and (D) end-of-study survey (n=393,396), by race/ethnic group adjusting for age category; sex; body mass index; a history of hypertension, diabetes, heart failure, and stroke; smoking status; and ADI. Higher odds indicate greater likelihood for completing the study procedure.
See this image and copyright information in PMC

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