Decentralized Trial in Atrial Fibrillation Patients

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04471623
• Other study ID #: 57019
• Status: Completed
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: March 12, 2021

Study information

• Verified date: March 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Use 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

Locations

Country	Name	City	State
United States	Stanford	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & 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

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 decentral — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement with study protocol	Composite endpoint of: % daily OAC adherence; % Completion of telehealth visits; % Completion of lab test; % Survey completion	6 months
Primary	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