Implementation of the YouControl-AFib mHealth Application (Pilot Version) to Improve Physical Activity in Persons With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Average Number of Participants Recruited Per Month
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
People using YouControl-A-Fib app
干预措施: YouControl-A-Fib mHealth Application (Device)
结局指标
主要结局
Average Number of Participants Recruited Per Month
时间窗: up to 6 months
Maximum Number of Participants Recruited in a Single Month
时间窗: up to 6 months
Mobile App Rating Scale Score
时间窗: 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. The overall mean score for all sub-scales is reported here.
Average Number of Participants Recruited Per Month
时间窗: up to 5 months
Maximum Number of Participants Recruited Per Month
时间窗: up to 5 months
Mobile App Rating Scale Scores
时间窗: 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.
次要结局
- Change in 6-minute Walk Distance (Compared to Baseline for Each Participant) After Using the mHealth App for 3 Months(baseline, 3 months)
- Weekly Step Count After Using the mHealth App for Three Months(week 1, week 12)
- Intentional Activity Time (in One Week) After Using the mHealth App for Three Months(week 1, week 12)
- General Quality of Life Questionnaire: SF-12 Physical Component Summary Score(baseline, 3 months)
- General Quality of Life Questionnaire: SF-12 Mental Component Summary Score(baseline, 3 months)
- Patient Health Questionnaire (PHQ-9) Score(baseline, 3 months)
- Atrial Fibrillation Symptom Severity (AFSS) Score(baseline, 3 months)
- Percent Correct on the Atrial Fibrillation Knowledge Assessment Tool (AFKAT)(baseline, 3 months)
- Life's Essential 8 Score After Using the mHealth App for Three Months(baseline, 3 months)
- Irregular Heart Rate Notifications (in One Week) After Using the mHealth App for Three Months(baseline, 3 months)
- Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score(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 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)
- 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 Atrial Fibrillation Knowledge Assessment Tool (AFKAT) Score(baseline, 3 months)
- Change in the Life's Essential 8 score 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)
- Change in Atrial Fibrillation Symptom Severity (AFSS) Score(baseline, 3 months)