Heart Watch Study: a Pragmatic Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Heart Watch Study: a Pragmatic Randomized Controlled Trial

Conditions
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Cardioversion, Atrial Fibrillation

Intervention / Treatment
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* Device: Apple Watch
* Device: Withings Move


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apple Watch<br>Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities. | Device: Apple Watch<br>* 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.<br>|
| Placebo Comparator: Withings Move<br>Patients will be provided with the Withings Move with activity tracking. | Device: Withings Move<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |