Clinical trial NCT04471623: Decentralized Trial in Atrial Fibrillation Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 102
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Engagement with study protocol
timeFrame: 6 months
measure: Effectiveness of notifications
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Rajesh Dash, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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
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.