Clinical trial NCT06575348: Evaluation of YouControl-AFib, a mHealth Application for Persons With Atrial Fibrillation
Official title: Implementation of the YouControl-AFib mHealth Application (Pilot Version) to Improve Physical Activity in Persons With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: physical exercise
application
supportive care
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-08-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Number of Participants Recruited Per Month
timeFrame: up to 5 months
measure: Maximum Number of Participants Recruited Per Month
timeFrame: up to 5 months
measure: Mobile App Rating Scale Scores
timeFrame: 3 months
Secondary outcomes:
measure: Change in 6-minute walk distance (compared to baseline for each participant) after using the mHealth app for 3 months
timeFrame: baseline, 3 months
measure: Change in daily step count (averaged over 7 days) after using the mHealth app for three months
timeFrame: baseline, 3 months
measure: Change in intentional activity time (in one week) after using the mHealth app for three months
timeFrame: baseline, 3 months
measure: Change in general quality of life questionnaire: SF-12 Score
timeFrame: baseline, 3 months
measure: Change in Patient Health Questionnaire (PHQ-9) Score
timeFrame: baseline, 3 months
measure: Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score
timeFrame: baseline, 3 months
measure: Change in Atrial Fibrillation Symptom Severity (AFSS) Score
timeFrame: baseline, 3 months
measure: Change in Atrial Fibrillation Knowledge Assessment Tool (AFKAT) Score
timeFrame: baseline, 3 months
measure: Change in the Life's Essential 8 score after using the mHealth app for three months
timeFrame: baseline, 3 months
measure: Change in irregular heart rate notifications (in one week) after using the mHealth app for three months
timeFrame: baseline, 3 months
measure: Change in ECG-age after using the mHealth app for three months
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Matthew M Kalscheur, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.