NCT04471623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2021

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

July 10, 2020

Last Update Submit

March 22, 2023

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Engagement with study protocol

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

    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

    6 months

Study Arms (1)

DeTAP Study App and Home Devices

EXPERIMENTAL

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

Behavioral: Use of DeTAP App and Home Devices

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

DeTAP Study App and Home Devices

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford

Stanford, California, 94305, United States

Location

Related Publications (2)

  • 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

    BACKGROUND

  • 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.

    PMID: 35764796RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rajesh Dash, MD PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiovascular Medicine

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 15, 2020

Study Start

August 10, 2020

Primary Completion

March 12, 2021

Study Completion

March 12, 2021

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)