Clinical trial NCT04468321: Heart Watch Study: a Pragmatic Randomized Controlled Trial
Official title: Heart Watch Study: a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardioversion
Atrial Fibrillation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Duke University
name: National Evaluation System for health Technology Coordinating Center
First posted: 2020-07-13
Enrollment: 105
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Age \>22
* 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

Primary outcomes:
measure: Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
timeFrame: baseline and 12 months
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms
timeFrame: 6 months
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms
timeFrame: 12 months
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities
timeFrame: 6 months
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities
timeFrame: 12 months
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern
timeFrame: 6 months
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern
timeFrame: 12 months
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction
timeFrame: 6 months
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction
timeFrame: 12 months
measure: Proportion of Patients Taking Anticoagulants
timeFrame: 6 months
measure: Proportion of Patients Taking Anticoagulants
timeFrame: 12 months
measure: Proportion of Participants With Acute Care Use at 6 Months
timeFrame: 6 months
measure: Proportion of Participants With Acute Care Use at 12 Months
timeFrame: 12 months
measure: Proportion of Participants With Outpatient Care Use at 6 Months
timeFrame: 6 months
measure: Proportion of Participants With Outpatient Care Use at 12 Months
timeFrame: 12 months
measure: Proportion of Participants With Rhythm-related Diagnostic Testing at 6 Months
timeFrame: 6 months
measure: Proportion of Participants With Rhythm-related Diagnostic Testing at 12 Months
timeFrame: 12 months
measure: Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter
timeFrame: 6 months
measure: Proportion of Participants With Clinical Treatment for Atrial Fibrillation or Flutter
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Yale University
name: Joseph Ross, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Peter Noseworthy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Sreekanth Vemulapalli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Sanket Dhruva, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhruva SS, Shah ND, Vemulapalli S, Deshmukh A, Beatty AL, Gamble GM, Freeman JV, Hummel JP, Piccini JP, Akar JG, Ervin K, Arges KL, Emanuel L, Noseworthy PA, Hu T, Bartlett V, Ross JS. Heart Watch Study: protocol for a pragmatic randomised controlled trial. BMJ Open. 2021 Dec 30;11(12):e054550. doi: 10.1136/bmjopen-2021-054550.