Decentralized Trial in Atrial Fibrillation Patients (DeTAP)

Stanford University

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Behavioral: Use of DeTAP App and Home Devices

Study type

Interventional

Funder types

Other

Identifiers

NCT04471623

57019

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.
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