Status:
COMPLETED
Evaluation of YouControl-AFib, a mHealth Application for Persons With Atrial Fibrillation
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is being done to establish the feasibility of performing a clinical trial using a mHealth application named YouControl-AFib designed to improve the cardiovascular health of persons with atr...
Detailed Description
Primary Objective * To effectively recruit participants for a clinical trial and obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions. Secondary Objecti...
Eligibility Criteria
Inclusion
- Ability to understand and the willingness to sign a written informed consent document
- Willing to comply with all study procedures and be available for the duration of the study
- SmartPhone capable of pairing with a Fitbit Sense 2 and Fitbit App (Apple iOS 15 and higher or Android 10 or higher)
- Paroxysmal or persistent atrial fibrillation verified by 12-lead electrocardiogram (ECG) or other clinical grade monitoring
- body mass index (BMI) greater than 27
Exclusion
- History of permanent atrial fibrillation
- Left ventricular ejection fraction (LVEF) less than 45 percent
- Myocardial infarction, coronary artery bypass grafting, or valve surgery within the last 12 months
- Moderate to severe valve disease
- Inability to participate in a structured exercise program due to musculoskeletal disease
- Already participating in a structured exercise program or achieving guideline directed physical activity
- Planned surgery or procedure during the next three months that limit ability to engage in physical activity
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06575348
Start Date
October 14 2024
End Date
July 22 2025
Last Update
August 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UW School of Medicine and Public Health
Madison, Wisconsin, United States, 53792