Evaluation of YouControl-AFib, a mHealth Application for Persons With Atrial Fibrillation

Implementation of the YouControl-AFib mHealth Application (Pilot Version) to Improve Physical Activity in Persons With Atrial Fibrillation

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 atrial fibrillation. The study will obtain feedback on the app design to inform future versions and will collect preliminary data to support proof-of-concept and potential effect sizes for future trial design.

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 Objectives

• To evaluate the impact of the YouControl-AFib mHealth app (pilot version, 3 months of use) on physical activity in persons with atrial fibrillation.
• To obtain several additional functional and disease specific endpoints that will help establish possible effect sizes to be evaluated more formally in subsequent versions of the mHealth application.
• To obtain user feedback on the mHealth app using the Mobile App Rating Scale and focus group sessions.

Inclusion Criteria:

• 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 Criteria:

• 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