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Heart Watch Study: a Pragmatic Randomized Controlled Trial

NCT04468321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-04-18

Study results available
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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.

Conditions

Interventions

DEVICE

Apple Watch

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.

DEVICE

Withings Move

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.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • National Evaluation System for health Technology Coordinating Center

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Joseph Ross, MD, MHS · Yale University

  • Peter Noseworthy, MD · Mayo Clinic

  • Sreekanth Vemulapalli, MD · Duke University

  • Sanket Dhruva, MD, MHS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2023-12-01
Completion
2024-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04468321 on ClinicalTrials.gov