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Decentralized Trial in Atrial Fibrillation Patients (DeTAP)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of DeTAP App and Home Devices
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.
  • Does not speak English

Sites / Locations

  • Stanford

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DeTAP Study App and Home Devices

Arm Description

Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies

Outcomes

Primary Outcome Measures

Engagement with study protocol
Composite endpoint of: % daily OAC adherence % Completion of telehealth visits % Completion of lab test % Survey completion
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

Secondary Outcome Measures

Full Information

First Posted
July 10, 2020
Last Updated
March 22, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04471623
Brief Title
Decentralized Trial in Atrial Fibrillation Patients
Acronym
DeTAP
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DeTAP Study App and Home Devices
Arm Type
Experimental
Arm Description
Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies
Intervention Type
Behavioral
Intervention Name(s)
Use of DeTAP App and Home Devices
Intervention Description
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 Measure Information:
Title
Engagement with study protocol
Description
Composite endpoint of: % daily OAC adherence % Completion of telehealth visits % Completion of lab test % Survey completion
Time Frame
6 months
Title
Effectiveness of notifications
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Dash, MD PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
K Josan, A Touros, C Petlura, V Parameswaran, U Grewal, M Senior, T Viethen, H Mundl, C Seninger, J Luithle, K Mahaffey, M Turakhia, R Dash, Validation of a pandemic-proof, decentralized cardiovascular trial: scalable design produces rapid recruitment, high engagement and protocol adherence in DeTAP (Decentralized Trial in Afib Patients), European Heart Journal, Volume 42, Issue Supplement_1, October 2021, ehab724.3177, https://doi.org/10.1093/eurheartj/ehab724.3177
Results Reference
background
PubMed Identifier
35764796
Citation
Sarraju A, Seninger C, Parameswaran V, Petlura C, Bazouzi T, Josan K, Grewal U, Viethen T, Mundl H, Luithle J, Basobas L, Touros A, Senior MJT, De Lombaert K, Mahaffey KW, Turakhia MP, Dash R. Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP). NPJ Digit Med. 2022 Jun 28;5(1):80. doi: 10.1038/s41746-022-00622-9.
Results Reference
result

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Decentralized Trial in Atrial Fibrillation Patients

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