Decentralized Trial in Atrial Fibrillation Patients (DeTAP): Validation of a Combined Digital Health Technology Approach to Fully Decentralize an Intervention to Administer, Promote, and Track Oral Anticoagulant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Engagement with study protocol
研究概览
简要总结
The purpose of this study is to validate an approach to decentralize, or virtualize, the clinical trial experience for enrolled subjects, through the coordinated use of multiple digital health and telehealth technologies. The study aims to validate the feasibility, acceptability and best practices of coordinating/integrating several individual digital health technologies to achieve execution of high compliance, cost-efficient, and scientifically sound clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Atrial Fibrillation documented (health record diagnosis or EKG) within the past year and taking an oral anticoagulant (OAC) medication for stroke prevention
- •Uses a smart phone daily and is willing to use apps and home devices for the study
- •Agreeable to use a Televisit method to conduct all study visits from trial team
排除标准
- •Active angina, stable or unstable, requiring urgent cardiovascular functional risk stratification (stress testing or catheterization) or intervention. Or has congestive heart failure that is not compensated or in which the subject is not euvolemic, as determined by the treating MD
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
- •Does not speak English
研究组 & 干预措施
DeTAP Study App and Home Devices
Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies
干预措施: Use of DeTAP App and Home Devices (Behavioral)
结局指标
主要结局
Engagement with study protocol
时间窗: 6 months
Composite endpoint of: * % daily OAC adherence * % Completion of telehealth visits * % Completion of lab test * % Survey completion
Effectiveness of notifications
时间窗: 6 months
Composite endpoint of: * Time from App-based survey notification to completion * Time from App-based lab reminder notification to lab collection * Time from App-based home vital sign/EKG reminder notification to vital sign/EKG collection
次要结局
未报告次要终点
研究者
Rajesh Dash, MD PHD
Associate Professor of Cardiovascular Medicine
Stanford University