Decentralized Trial in Atrial Fibrillation Patients

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of DeTAP App and Home Devices

Behavioral

DeTAP App (data collection, televisit function, information and reminders), Bluetooth-connected 6-lead home (electrocardiogram) EKG device, Bluetooth-connected blood pressure (BP) cuff

Primary outcomes

Engagement with study protocol

Time frame: 6 months
Composite endpoint of:
- % daily OAC adherence
- % Completion of telehealth visits
- % Completion of lab test
- % Survey completion
Effectiveness of notifications

Time frame: 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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

Acronym: DeTAP

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jul 15, 2020
Registry last updated: Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed