Atrial Fibrillation
Conditions
Keywords
physical exercise, application, 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.
Interventions
DEVICEYouControl-A-Fib mHealth Application
Participants will use the app for 3 months, includes 1 month phone call with Health Coach
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in general quality of life questionnaire: SF-12 Score | 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. |
| Change in Patient Health Questionnaire (PHQ-9) Score | 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. |
| Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score | baseline, 3 months | 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. |
| Change in Atrial Fibrillation Symptom Severity (AFSS) Score | 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. |
| 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 the Life's Essential 8 score after using the mHealth app for three months | 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. |
| 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 | 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. |
| Change in Atrial Fibrillation Knowledge Assessment Tool (AFKAT) Score | 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. |
| 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 | — |
Countries
United States
Outcome results
None listed