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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: YouControl-A-Fib mHealth Application

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): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

1

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		up to 5 months
Maximum Number of Participants Recruited Per Month		up to 5 months
Mobile App Rating Scale Scores	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.	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		baseline, 3 months
Change in daily step count (averaged over 7 days) after using the mHealth app for three months		baseline, 3 months
Change in intentional activity time (in one week) after using the mHealth app for three months		baseline, 3 months
Change in general quality of life questionnaire: SF-12 Score	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
Change in Patient Health Questionnaire (PHQ-9) Score	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	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.	baseline, 3 months
Change in Atrial Fibrillation Symptom Severity (AFSS) Score	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
Change in Atrial Fibrillation Knowledge Assessment Tool (AFKAT) Score	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.	baseline, 3 months
Change in the Life's Essential 8 score after using the mHealth app for three 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
Change in irregular heart rate notifications (in one week) after using the mHealth app for three months		baseline, 3 months
Change in ECG-age after using the mHealth app for three 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

• 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

General Publications

• Attia ZI, Friedman PA, Noseworthy PA, Lopez-Jimenez F, Ladewig DJ, Satam G, Pellikka PA, Munger TM, Asirvatham SJ, Scott CG, Carter RE, Kapa S. Age and Sex Estimation Using Artificial Intelligence From Standard 12-Lead ECGs. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007284. doi: 10.1161/CIRCEP.119.007284. Epub 2019 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 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): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: supportive care; physical exercise; application
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• 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