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

NCT06575348 | Completed FDA Device

• 4 other identifiers: 2024-0954A534225Protocol Version 8/6/20241UL1TR002373
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

physical exercise; application; supportive care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

  baseline, 3 months

• Change in Patient Health Questionnaire (PHQ-9) Score

  baseline, 3 months

Study Arms (1)

People using YouControl-A-Fib app

EXPERIMENTAL

Device: YouControl-A-Fib mHealth Application

Interventions

YouControl-A-Fib mHealth Application DEVICE

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

People using YouControl-A-Fib app

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 31450977 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Motor Activity

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Matthew M Kalscheur, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 28, 2024
• Study Start: October 14, 2024
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)