Decentralized Trial in Atrial Fibrillation Patients

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Behavioral: Use of DeTAP App and Home Devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DeTAP Study App and Home Devices<br>Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies | Behavioral: Use of DeTAP App and Home Devices<br>* DeTAP App (data collection, televisit function, information and reminders), Bluetooth-connected 6-lead home (electrocardiogram) EKG device, Bluetooth-connected blood pressure (BP) cuff<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement with study protocol | Composite endpoint of: % daily OAC adherence % Completion of telehealth visits % Completion of lab test % Survey completion | 6 months | 
| Effectiveness of notifications | 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 | 6 months |