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

University of Wisconsin (UW)

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: YouControl-A-Fib mHealth Application

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06575348

1UL1TR002373 (U.S. NIH Grant/Contract)

2024-0954

A534225 (Other Identifier)

Protocol Version 8/6/2024 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

52 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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