Heart Watch Study: a Pragmatic Randomized Controlled Trial

January 16, 2024 updated by: Yale University
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.

Study Overview

Status

Active, not recruiting

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apple Watch
Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities.
Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
Placebo Comparator: Withings Move
Patients will be provided with the Withings Move with activity tracking.
Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
Time Frame: 6 months
Difference 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with acute care use at 6 months
Time Frame: 6 months
Acute care use will be compared between the two groups at 6 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 6 month period.
6 months
Proportion of participants with acute care use at 12 months
Time Frame: 12 months
Acute care use will be compared between the two groups at 12 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 12 month period.
12 months
Proportion of participants with outpatient care use at 6 months
Time Frame: 6 months
Outpatient care use will be compared between the two groups at 6 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.
6 months
Proportion of participants with outpatient care use at 12 months
Time Frame: 12 months
Outpatient care use will be compared between the two groups at 12 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.
12 months
Proportion of participants with rhythm-related diagnostic testing at 6 months
Time Frame: 6 months
Rhythm-related diagnostic testing will be assessed at 6 month including total ECGs and total outpatient heart rhythm monitors
6 months
Proportion of participants with rhythm-related diagnostic testing at 12 months
Time Frame: 12 months
Rhythm-related diagnostic testing will be assessed at 12 month including total ECGs and total outpatient heart rhythm monitors
12 months
Proportion of patients taking anticoagulants
Time Frame: 6 months
Anticoagulation use will be assessed at 6 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use
6 months
Proportion of patients taking anticoagulants
Time Frame: 12 months
Anticoagulation use will be assessed at 12 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use
12 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domains
Time Frame: 6 months
Difference within individual domains of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6 month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
6 months
Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domains
Time Frame: 12 months
Difference within individual domains of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12 month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
12 months
Proportion of participants with clinical treatment for atrial fibrillation or flutter
Time Frame: 6 months
A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 6 month period. The medication data will be obtained primarily from electronic health record data.
6 months
Proportion of participants with clinical treatment for atrial fibrillation or flutter
Time Frame: 12 months
A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 12 month period. The medication data will be obtained primarily from electronic health record data.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Peter Noseworthy, MD, Mayo Clinic
  • Principal Investigator: Sreekanth Vemulapalli, MD, Duke University
  • Principal Investigator: Sanket Dhruva, MD, MHS, University of California, San Francisco
  • Principal Investigator: Joseph Ross, MD, MHS, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2021

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2000028126
  • 6292-2020-R2TC-T12T13 (Other Grant/Funding Number: Medical Device Innovation Consortium, on behalf of the NESTcc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the study has been completed, IPD will be shared in a way which will protect patient confidentiality using a data sharing platform for research purposes

IPD Sharing Time Frame

Data will become available once the study has been completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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