对 YouControl-AFib（一款针对心房颤动患者的移动医疗应用程序）的评估
实施 YouControl-AFib mHealth 应用程序（试点版）以改善心房颤动患者的体力活动
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792
- UW School of Medicine and Public Health
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：使用 YouControl-A-Fib 应用程序的用户
|
Participants will use the app for 3 months, includes 1 month phone call with Health Coach |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Average Number of Participants Recruited Per Month
大体时间：up to 6 months
|
up to 6 months
|
|
|
Maximum Number of Participants Recruited in a Single Month
大体时间：up to 6 months
|
up to 6 months
|
|
|
Mobile App Rating Scale Score
大体时间：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. |
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in 6-minute Walk Distance (Compared to Baseline for Each Participant) After Using the mHealth App for 3 Months
大体时间：baseline, 3 months
|
baseline, 3 months
|
|
|
Weekly Step Count After Using the mHealth App for Three Months
大体时间：week 1, week 12
|
week 1, week 12
|
|
|
Intentional Activity Time (in One Week) After Using the mHealth App for Three Months
大体时间：week 1, week 12
|
week 1, week 12
|
|
|
General Quality of Life Questionnaire: SF-12 Physical Component Summary Score
大体时间：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. |
baseline, 3 months
|
|
General Quality of Life Questionnaire: SF-12 Mental Component Summary Score
大体时间：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. |
baseline, 3 months
|
|
Patient Health Questionnaire (PHQ-9) Score
大体时间：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. |
baseline, 3 months
|
|
Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) Score
大体时间：baseline, 3 months
|
AFEQT is a 20-item survey scored on a 7 point likert scale from 1-7 (total possible range of scores is converted to be from 0-100) where higher scores indicate higher effect that atrial fibrillation has on the participant's quality of life. |
baseline, 3 months
|
|
Atrial Fibrillation Symptom Severity (AFSS) Score
大体时间：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. |
baseline, 3 months
|
|
Percent Correct on the Atrial Fibrillation Knowledge Assessment Tool (AFKAT)
大体时间：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. Reported here is the percent correct. |
baseline, 3 months
|
|
Life's Essential 8 Score After Using the mHealth App for Three Months
大体时间：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. |
baseline, 3 months
|
|
Irregular Heart Rate Notifications (in One Week) After Using the mHealth App for Three Months
大体时间：baseline, 3 months
|
baseline, 3 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in ECG-age After Using the mHealth App for Three Months
大体时间：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. |
baseline, 3 months
|
合作者和调查者
调查人员
- 首席研究员：Matthew M Kalscheur, MD、UW School of Medicine and Public Health
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2024-0954
- A534225 (其他标识符：UW Madison)
- Protocol Version 8/6/2024 (其他标识符：UW Madison)
- 1UL1TR002373 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. Every attempt will be made to publish results in peer-reviewed journals.
IPD 共享时间框架
Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting the PI.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.