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Decentralized Trial in Atrial Fibrillation Patients (DeTAP)

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ClinicalTrials.gov Identifier: NCT04471623
Recruitment Status : Active, not recruiting
First Posted : July 15, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Rajesh Dash, MD PHD, 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: DeTAP App and Home Devices Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DeTAP Study App and Home Devices
Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies
Device: DeTAP App and Home Devices
DeTAP App (data collection, televisit function, information and reminders), Bluetooth-connected 6-lead home (electrocardiogram) EKG device, Bluetooth-connected blood pressure (BP) cuff




Primary Outcome Measures :
  1. Engagement with study protocol [ Time Frame: 6 months ]

    Composite endpoint of:

    • % daily OAC adherence
    • % Completion of telehealth visits
    • % Completion of lab test
    • % Survey completion

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04471623


Locations
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United States, California
Stanford
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Rajesh Dash, MD PhD Stanford University
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Responsible Party: Rajesh Dash, MD PHD, Associate Professor of Cardiovascular Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT04471623    
Other Study ID Numbers: 57019
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes