Apple Watch and Withings Evaluation of Symptoms, Treatment, and Rhythm in those Undergoing Cardioversion (AWE STRUCk): A Pragmatic Randomized Controlled Trial

IntroductionPersonal digital devices that provide health information, such as the Apple Watch, have developed an increasing array of cardiopulmonary tracking features which have received regulatory clearance and are directly marketed to consumers. Despite their widespread and increasing use, data about the impact of personal digital device use on patient-reported outcomes and healthcare utilization are sparse. Among a population of patients with atrial fibrillation undergoing cardioversion, our primary aim is to determine the impact of the heart rate measurement, irregular rhythm notification, and electrocardiogram features of the Apple Watch on quality of life and healthcare utilization. Methods and analysisWe are conducting a prospective, open-label multicenter pragmatic randomized clinical trial, leveraging a unique patient-centered health data sharing platform for enrollment and follow-up. A total of 150 patients undergoing cardioversion for atrial fibrillation (or atrial flutter, if they have a history of atrial fibrillation) will be randomized 1:1 to receive the Apple Watch Series 6 or Withings Move at the time of cardioversion. The primary outcome is the difference in the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) global score at six months post-cardioversion. Secondary outcomes include inpatient and outpatient healthcare utilization. Additional secondary outcomes include a comparison of the Apple Watch ECG and pulse oximeter features with gold standard data obtained in routine clinical care settings. Ethics and disseminationThe Institutional Review Boards at Yale University, Mayo Clinic, and Duke University Health System have approved the trial protocol. This trial will provide important data to policymakers, clinicians, and patients about the impact of the heart rate, irregular rhythm notification, and electrocardiogram features of widely used personal digital devices on patient quality of life and healthcare utilization. Findings will be disseminated to study participants, at professional society meetings, and in peer-reviewed journals. Trial registration numberNCT04468321 Strengths and limitations of this studyO_LIThis randomized clinical trial will use a patient-centered health data sharing platform for study enrollment and follow-up, leveraging patient ownership over health data and patient engagement with researchers. C_LIO_LIThis is the first study to examine the impact of electrocardiogram and irregular rhythm notification features of personal digital technologies on patient-reported quality-of-life among patients with atrial fibrillation. C_LIO_LIDue to costs of personal digital devices, our study is powered to identify a difference of 8.8 on the primary outcome of Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) global score, which is greater than the minimal clinically important difference of 5. C_LIO_LIOur study focuses on a subset of patients with atrial fibrillation, and the findings may not be generalizable to those who do not have atrial fibrillation. C_LI