Heart Watch Study: a Pragmatic Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 105
- Locations
- 6
- Primary Endpoint
- Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
Study Overview
Brief Summary
This will be a prospective multi-center, randomized, controlled trial of 150 patients conducted to assess the impact of individual use of the Apple Watch compared to the Withings Move on patient-reported and clinical outcomes at 6 months and up to 1 year.
Detailed 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 (called Hugo) for real-world surveillance of outcomes in 150 total patients after they receive elective direct current cardioversion (DCCV) or catheter ablation for treatment of atrial fibrillation or atrial flutter. Patients will be enrolled at each of 3 clinical sites: Yale-New Haven Hospital, the Mayo Clinic, and Duke Health. 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 or catheter ablation for atrial fibrillation or atrial flutter.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English-speaking
- •Planned for direct current cardioversion or catheter ablation for atrial fibrillation or atrial flutter, as noted by referring clinical staff or on chart review
- •Participant is willing and able to read and sign consent and participate in study
- •Participant lives independently and does not require continuous care
- •Participant has an email account (or is willing to create one)
- •Participant has a compatible smartphone (iPhone 6s or later)
- •Participant is willing to wear only the device they are randomized to receive for the study period for as many hours during the day as they are able, except for time spent charging the device or in environments that may be suboptimal for the device
- •Participant is willing to use the Hugo mobile health platform and Apple Watch Series 6 or Withings Move
- •Participant has cardiology care at YNHH, Duke Health, or Mayo Clinic
Exclusion Criteria
- •No exclusion criteria
Outcomes
Primary Outcomes
Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
Time Frame: baseline and 6 months
Change in the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire global score at 6 months compared to baseline between the Apple Watch and patients randomized to the Withings Move arm at 6 months compared to baseline. Reported on a scale from 0 to 100 with a higher score indicating a better outcome.
Secondary Outcomes
- Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)(baseline and 12 months)
- Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms(12 months)
- Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities(12 months)
- Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern(12 months)
- Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction(12 months)
- Proportion of Patients Taking Anticoagulants(12 months)
- Proportion of Participants With Acute Care Use at 6 Months(6 months)
- Proportion of Participants With Acute Care Use at 12 Months(12 months)
- Proportion of Participants With Outpatient Care Use at 6 Months(6 months)
- Proportion of Participants With Outpatient Care Use at 12 Months(12 months)
- Proportion of Participants With Rhythm-related Diagnostic Testing at 6 Months(6 months)
- Proportion of Participants With Rhythm-related Diagnostic Testing at 12 Months(12 months)
- Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter(12 months)