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

Last updated: May 15, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

YouControl-A-Fib mHealth Application

Clinical Study ID

NCT06575348
2024-0954
A534225
Protocol Version 8/6/2024
1UL1TR002373
  • Ages 18-80
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consentdocument

  • Willing to comply with all study procedures and be available for the duration of thestudy

  • SmartPhone capable of pairing with a Fitbit Sense 2 and Fitbit App (Apple iOS 15 andhigher 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

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 thelast 12 months

  • Moderate to severe valve disease

  • Inability to participate in a structured exercise program due to musculoskeletaldisease

  • Already participating in a structured exercise program or achieving guidelinedirected physical activity

  • Planned surgery or procedure during the next three months that limit ability toengage in physical activity

Study Design

Total Participants: 52
Treatment Group(s): 1
Primary Treatment: YouControl-A-Fib mHealth Application
Phase:
Study Start date:
October 14, 2024
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • UW School of Medicine and Public Health

    Madison, Wisconsin 53792
    United States

    Site Not Available

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