Decentralized Trial in Atrial Fibrillation Patients

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Behavioral: Use of DeTAP App and Home Devices

• Registration Number: NCT04471623
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-15
• Study Start: 2020-08-10
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DeTAP Study App and Home Devices	Use of DeTAP App and Home Devices	Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies

Primary Outcome Measures

Name	Time	Method
Engagement with study protocol	6 months	Composite endpoint of: * % daily OAC adherence; * % Completion of telehealth visits; * % Completion of lab test; * % Survey completion
Effectiveness of notifications	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

Trial Locations

Locations (1)

Stanford; 🇺🇸 Stanford, California, United States