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CompletedNCT04471623DeTAPUpdated Mar 24, 2023

Decentralized Trial in Atrial Fibrillation Patients

An interventional study of Use of DeTAP App and Home Devices in Atrial Fibrillation, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.

Sponsored by Stanford University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Ages
55 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Atrial Fibrillation

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In context

Atrial Fibrillation

3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.

This study's enrollment of 102 is below the median of 144 across 2,381 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    DeTAP Study App and Home Devices

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

    Behavioral: Use of DeTAP App and Home Devices

Interventions

  • BehavioralUse of 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

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What researchers measure

Primary outcomes

  1. Engagement with study protocol

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

    Time frame: 6 months

  2. 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

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Study locations

1 site
  • Stanford
    Stanford, California 94305, United States
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References and documents

Publications

  • 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
  • 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. PubMed 35764796 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04471623
Lead sponsor
Stanford University
Responsible party
Rajesh Dash, MD PHD (Associate Professor of Cardiovascular Medicine, Stanford University) — Principal investigator
First posted
Jul 15, 2020
Start date
Aug 10, 2020
Primary completion
Mar 12, 2021
Completion
Mar 12, 2021
Last update
Mar 24, 2023

Study contacts

Rajesh Dash, MD PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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