Evaluation of YouControl-AFib, a mHealth Application for Persons With Atrial Fibrillation
NCT Number: NCT06575348
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation
Interventions: DEVICE: YouControl-A-Fib mHealth Application
Sponsor: University of Wisconsin, Madison
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-06

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.

Primary Outcome Measures: 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: 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