Decentralized Trial in Atrial Fibrillation Patients

Stanford University102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

102

Conditions

Atrial Fibrillation

Interventions

Use of DeTAP App and Home DevicesBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford

Stanford, California, United States

Outcomes

Primary Outcomes

Engagement with study protocol

Composite endpoint of: * % daily OAC adherence * % Completion of telehealth visits * % Completion of lab test * % Survey completion

Time frame: 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

Time frame: 6 months

Data from ClinicalTrials.gov

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