- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04468321
Heart Watch Study: a Pragmatic Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica Ritchie, MPH
- Phone Number: (203)497-1239
- Email: afibstudy@yale.edu
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale-New Haven Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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.
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Placebo Comparator: Withings Move
Patients will be provided with the Withings Move with activity tracking.
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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.
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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
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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.
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6 months
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Proportion of participants with acute care use at 12 months
Time Frame: 12 months
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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.
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12 months
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Proportion of participants with outpatient care use at 6 months
Time Frame: 6 months
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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.
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6 months
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Proportion of participants with outpatient care use at 12 months
Time Frame: 12 months
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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.
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12 months
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Proportion of participants with rhythm-related diagnostic testing at 6 months
Time Frame: 6 months
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Rhythm-related diagnostic testing will be assessed at 6 month including total ECGs and total outpatient heart rhythm monitors
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6 months
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Proportion of participants with rhythm-related diagnostic testing at 12 months
Time Frame: 12 months
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Rhythm-related diagnostic testing will be assessed at 12 month including total ECGs and total outpatient heart rhythm monitors
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12 months
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Proportion of patients taking anticoagulants
Time Frame: 6 months
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Anticoagulation use will be assessed at 6 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use
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6 months
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Proportion of patients taking anticoagulants
Time Frame: 12 months
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Anticoagulation use will be assessed at 12 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use
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12 months
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Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domains
Time Frame: 6 months
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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
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6 months
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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
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12 months
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Proportion of participants with clinical treatment for atrial fibrillation or flutter
Time Frame: 6 months
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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.
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6 months
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Proportion of participants with clinical treatment for atrial fibrillation or flutter
Time Frame: 12 months
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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.
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
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
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
IPD Plan Description
IPD Sharing Time Frame
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
Studies a U.S. FDA-regulated device product
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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