Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study
| Autor: | Mellanie True Hills, Andrea M. Russo, Kenneth W. Mahaffey, Nisha Talati, John S. Rumsfeld, Christopher B. Granger, Mintu P. Turakhia, Todd A. Ferris, Haley Hedlin, Peter R. Kowey, Divya Nag, Marco V Perez, Manisha Desai, Amol Rajmane, Mithun Patel, Sumbul A Desai |
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| Rok vydání: | 2019 |
| Předmět: |
Telemedicine
medicine.medical_specialty Time Factors Wearable computer 030204 cardiovascular system & hematology Article Smartwatch Wearable Electronic Devices 03 medical and health sciences 0302 clinical medicine Physical medicine and rehabilitation Photoplethysmogram Atrial Fibrillation Humans Medicine Patient Reported Outcome Measures Prospective Studies 030212 general & internal medicine Wearable technology business.industry Atrial fibrillation Patient Acceptance of Health Care medicine.disease Mobile Applications Atrial Flutter Ambulatory Electrocardiography Ambulatory Smartphone Cardiology and Cardiovascular Medicine business Algorithms Atrial flutter |
| Zdroj: | American heart journal |
| ISSN: | 0002-8703 |
| Popis: | Background Smartwatch and fitness band wearable consumer electronics can passively measure pulse rate from the wrist using photoplethysmography (PPG). Identification of pulse irregularity or variability from these data has the potential to identify atrial fibrillation or atrial flutter (AF, collectively). The rapidly expanding consumer base of these devices allows for detection of undiagnosed AF at scale. Methods The Apple Heart Study is a prospective, single arm pragmatic study that has enrolled 419,093 participants (NCT03335800). The primary objective is to measure the proportion of participants with an irregular pulse detected by the Apple Watch (Apple Inc, Cupertino, CA) with AF on subsequent ambulatory ECG patch monitoring. The secondary objectives are to: 1) characterize the concordance of pulse irregularity notification episodes from the Apple Watch with simultaneously recorded ambulatory ECGs; 2) estimate the rate of initial contact with a health care provider within 3 months after notification of pulse irregularity. The study is conducted virtually, with screening, consent and data collection performed electronically from within an accompanying smartphone app. Study visits are performed by telehealth study physicians via video chat through the app, and ambulatory ECG patches are mailed to the participants. Conclusions The results of this trial will provide initial evidence for the ability of a smartwatch algorithm to identify pulse irregularity and variability which may reflect previously unknown AF. The Apple Heart Study will help provide a foundation for how wearable technology can inform the clinical approach to AF identification and screening. (Am Heart J 2019;207:66–75.) |
| Databáze: | OpenAIRE |
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