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| ID | Type | Description | Link |
|---|---|---|---|
| 24SCEFIA1249819 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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Atrial fibrillation (AF) affects 1 in 4 individuals during their lifetime and continues to increase in frequency and impact. Exercise intervention has established benefits to improve AF symptoms and burden in clinical studies. However, lack of access to exercise programs has limited therapeutic adoption. The growth of technology-driven health care and diagnostics, recognized as an emerging priority by the American Heart Association, offers an opportunity for a pragmatic and patient-centered approach to meet this need. EASE-AF is a prospective, interventional study with a sequential run-in control to evaluate if a digital health-driven, patient-centered exercise intervention improves AF symptoms and burden. The research team will enroll 120 patients with symptomatic, paroxysmal AF. The main impact of this study will be the establishment of evidence for a novel, pragmatic paradigm for a patient-centered, digital technology-driven personalized exercise intervention for patients with AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With Atrial Fibrillation | Experimental | Patients with symptomatic, paroxysmal AF. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Intervention Using FitBit Wearable Device | Device | The intervention is a digital technology-driven, patient-centric approach to physical activity and exercise intervention with tailored digital engagement and progressive physical activity goals (the intervention). The intervention will be conducted using FitBit wearable device. |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation Severity Scale (AFSS), Symptom Severity Domain | The Symptom Severity domain (Part C) of the validated Atrial Fibrillation Severity Scale (AFSS) questions patients regarding the severity of 7 AF-related symptoms (on scale of 0-5 per question, 5 denoting a great deal of symptom and 0 with no symptom) over the preceding 4-week period. Total scores range 0-35 on the Symptom Severity Domain of the Atrial Fibrillation Severity Scale (AFSS), higher score denotes more severe AF-related symptoms. | Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation Severity Scale (AFSS) | The full Atrial Fibrillation Severity Scale (AFSS) is composed of 19-items, investigating four domains: global well-being, symptom burden, health care utilization, symptom severity. Global well-being: 1-10; 10 denotes best possible quality of life. Symptom burden: Composite of AF burden as AF duration + AF frequency + AF severity; ranging 0-30, higher denotes more symptom burden. Health care utilization: ER visits (0-7, higher number denotes more utilization), Hospitalizations (0-7, higher number denotes more utilization), Specialist visits (0-7, higher number denotes more utilization); Symptom Severity: 0-35, higher score denotes more severe AF-related symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joshua Wiener | Contact | 646-761-3506 | EASE-AF@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Janice Y Chyou, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
Not planning to share individual participant data. Aggregate data will be shared instead.
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| Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period |
| AF Arrhythmia Burden: Percentage of time in AF | Global AF arrhythmia burden will be measured as percentage of time in AF measured during an 8-14-day monitoring period at the end of each time point as quantified by either clinically validated patch-based monitoring system or loop recorder. | Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period |
| AF Arrhythmia Burden: Duration of longest AF Arrhythmia Episode | Duration of the longest AF episode during the monitoring period will be quantified by either clinically validated patch-based monitoring system or loop recorder. | Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period |
| Weekly Step Counts | Weekly step counts measured by FitBit wearable device provided by the study | Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period |
| Weekly Exercise Minutes | Weekly exercise minutes measured by FitBit wearable device provided by the study | Baseline, End of 4-week Run-in Control Period, End of 24-week Physical Activity Intervention Period |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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