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

September 1, 2026 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • UW School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: People using YouControl-A-Fib app
Device: YouControl-A-Fib mHealth Application

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Number of Participants Recruited Per Month
Time Frame: up to 6 months
up to 6 months
Maximum Number of Participants Recruited in a Single Month
Time Frame: up to 6 months
up to 6 months
Mobile App Rating Scale Score
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. The overall mean score for all sub-scales is reported here.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 3 months
Weekly Step Count After Using the mHealth App for Three Months
Time Frame: week 1, week 12
week 1, week 12
Intentional Activity Time (in One Week) After Using the mHealth App for Three Months
Time Frame: week 1, week 12
week 1, week 12
General Quality of Life Questionnaire: SF-12 Physical Component Summary 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.
baseline, 3 months
General Quality of Life Questionnaire: SF-12 Mental Component Summary 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.
baseline, 3 months
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.
baseline, 3 months
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 (total possible range of scores is converted to be from 0-100) where higher scores indicate higher effect that atrial fibrillation has on the participant's quality of life.
baseline, 3 months
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.
baseline, 3 months
Percent Correct on the Atrial Fibrillation Knowledge Assessment Tool (AFKAT)
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. Reported here is the percent correct.
baseline, 3 months
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.
baseline, 3 months
Irregular Heart Rate Notifications (in One Week) After Using the mHealth App for Three Months
Time Frame: baseline, 3 months
baseline, 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Matthew M Kalscheur, MD, UW School of Medicine and Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2024

Primary Completion (Actual)

July 22, 2025

Study Completion (Actual)

July 22, 2025

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0954
  • A534225 (Other Identifier: UW Madison)
  • Protocol Version 8/6/2024 (Other Identifier: UW Madison)
  • 1UL1TR002373 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. Every attempt will be made to publish results in peer-reviewed journals.

IPD Sharing Time Frame

Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting the PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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