Effect of Wearable Devices on Patient-Reported Outcomes and Clinical Utilization
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atrial Fibrillation
- Cardioversion
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 22 years and 125 years
- Gender
- Both males and females
Description
This is a a randomized, controlled trial to determine the impact of the Apple Watch Series 6 compared to the Withings Move on both patient-reported outcomes and clinical utilization over 6 months and up to 1 year. Our research method will employ a patient-centered health data sharing platform (calle...
This is a a randomized, controlled trial to determine the impact of the Apple Watch Series 6 compared to the Withings Move on both patient-reported outcomes and clinical utilization over 6 months and up to 1 year. Our research method will employ a patient-centered health data sharing platform (called Hugo) for real-world surveillance of outcomes in 150 total patients after they receive elective direct current cardioversion (DCCV) for treatment of atrial fibrillation (or atrial flutter, if they have a history of atrial fibrillation). A total of 50 patients at each of 3 clinical sites, Yale-New Haven Hospital, the Mayo Clinic, and Duke Health before they undergo DCCV. Half of the patients will be randomized to receive the Apple Watch Series 6, while half will receive a control device (Withings Move). Patients will then be queried about specific symptoms related to atrial fibrillation and medication adherence monthly. This project will provide novel and needed post-market data about the Apple Watch Series 6 ECG and irregular rhythm detection notification features and, on a larger scale, help delineate the impact of an innovative digital health technology on real-world patient outcomes. Specific Aim 1: To assess the impact of using the Apple Watch ECG and irregular rhythm notification features on patient-reported outcomes and clinical utilization after patients receive cardioversion for atrial fibrillation (or atrial flutter, if they have a history of atrial fibrillation). Specific Aim 2: To determine the accuracy of the Apple Watch ECG compared to physician interpretation of 12-lead ECGs obtained in routine clinical care.
Tracking Information
- NCT #
- NCT04468321
- Collaborators
- Mayo Clinic
- Duke University
- National Evaluation System for health Technology Coordinating Center (NESTcc)
- Investigators
- Principal Investigator: Joseph Ross, MD, MHS Yale University Principal Investigator: Nilay Shah, PhD, MS Mayo Clinic Principal Investigator: Sreekanth Vemulapalli, MD Duke University Principal Investigator: Sanket Dhruva, MD, MHS University of California, San Francisco
Get Well Soon