ArticleMayo Clinic proceedings. Digital health2025
Racial and Ethnic Representation and Study Engagement in a Siteless Digital Clinical Trial Using a Smartwatch: Findings From the Apple Heart Study.
Article in Mayo Clinic proceedings. Digital health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03335800 (Apple Heart Study), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
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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