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Completed

NCT Number: NCT04468321

Heart Watch Study: a Pragmatic Randomized Controlled Trial

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.

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Key information

Conditions

Cardioversion Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apple Watch

Device

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.

Withings Move

Device

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.

Primary outcomes

  1. 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

  1. Change in Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)

    Time frame: baseline and 12 months

    Change in the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire global score at 12 months compared to baseline between the Apple Watch and patients randomized to the Withings Move arm at 12 months compared to baseline. Reported on a scale from 0 to 100 with a higher score indicating a better outcome.

  2. Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms

    Time frame: 6 months

    Difference within individual Symptoms domain 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

  3. Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Symptoms

    Time frame: 12 months

    Difference within individual Symptom domain 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

  4. Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities

    Time frame: 6 months

    Difference within individual Daily Activities domain 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

  5. Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Daily Activities

    Time frame: 12 months

    Difference within individual Daily Activities domain 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

  6. Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern

    Time frame: 6 months

    Difference within individual Treatment Concern domain 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

  7. Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Concern

    Time frame: 12 months

    Difference within individual Treatment Concern domain 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

  8. Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction

    Time frame: 6 months

    Difference within individual Treatment Satisfaction domain 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

  9. Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domain- Treatment Satisfaction

    Time frame: 12 months

    Difference within individual Treatment Satisfaction domain 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

  10. 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

  11. 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. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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

  17. 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

  18. 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.

  19. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Duke University
  • Mayo Clinic
  • National Evaluation System for health Technology Coordinating Center

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 13, 2020
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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