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Completed

NCT Number: NCT06575348

Evaluation of YouControl-AFib, a mHealth Application for 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Heart Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YouControl-A-Fib mHealth Application

Device

Participants will use the app for 3 months, includes 1 month phone call with Health Coach

Primary outcomes

  1. Average Number of Participants Recruited Per Month

    Time frame: up to 5 months

  2. Maximum Number of Participants Recruited Per Month

    Time frame: up to 5 months

  3. Mobile App Rating Scale Scores

    Time frame: 3 months

    Mobile App Rating Scale contains several subscales that will each be scored on a scale of 1-5; B-functionality, C-aesthetics, and D-information. Higher scores indicate high levels of functionality, aesthetics, and information quality.

Secondary outcomes

  1. Change in 6-minute walk distance (compared to baseline for each participant) after using the mHealth app for 3 months

    Time frame: baseline, 3 months

  2. Change in daily step count (averaged over 7 days) after using the mHealth app for three months

    Time frame: baseline, 3 months

  3. Change in intentional activity time (in one week) after using the mHealth app for three months

    Time frame: baseline, 3 months

  4. Change in general quality of life questionnaire: SF-12 Score

    Time frame: baseline, 3 months

    SF-12 measures the impact of health on the participant's life and is scored from 0-100 where higher scores indicates higher health related quality of life.

  5. Change in Patient Health Questionnaire (PHQ-9) Score

    Time frame: baseline, 3 months

    PHQ-9 is a 9-item questionnaire scored on a 4 point likert scale from 0-3 for a total possible range of scores from 0-27. Higher scores indicate increased depression.

  6. Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score

    Time frame: baseline, 3 months

    AFEQT is a 20-item survey scored on a 7 point likert scale from 1-7 where higher scores indicate higher effect that atrial fibrillation has on the participant's quality of life.

  7. Change in Atrial Fibrillation Symptom Severity (AFSS) Score

    Time frame: baseline, 3 months

    AFSS is a 7-item survey scored on a likert scale from 0-5 for a total possible range of scores from 0-35 where higher scores indicate greater symptom severity.

  8. Change in Atrial Fibrillation Knowledge Assessment Tool (AFKAT) Score

    Time frame: baseline, 3 months

    AFKAT is a 21-item true / false assessment that measures knowledge about atrial fibrillation. Correct answers are scored with a 1 for a total possible range of scores from 0-21. Higher scores indicate increased knowledge of atrial fibrillation.

  9. Change in the Life's Essential 8 score after using the mHealth app for three months

    Time frame: baseline, 3 months

    Life's Essential 8 score (LE8) is a composite score between 0-100 that assesses a participant's adherence to 8 lifestyle recommendations with improve cardiovascular health: diet, physical activity, smoking habits, body mass index, cholesterol, blood glucose, and sleep duration. Higher scores are indicative of higher adherence to healthy lifestyle.

  10. Change in irregular heart rate notifications (in one week) after using the mHealth app for three months

    Time frame: baseline, 3 months

  11. Change in ECG-age after using the mHealth app for three months

    Time frame: baseline, 3 months

    Participants will obtain single-lead ECGs at baseline and after three months. The time-voltage data are run through an ECG-AI model for estimating ECG-age. ECG-age is a novel metric developed by investigators at Wake Forest. See reference section for relevant publication describing a similar model. Summary results will be reported as ECG-age in years.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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