Atrial Fibrillation
Conditions
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.
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
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement with study protocol | 6 months | Composite endpoint of: * % daily OAC adherence * % Completion of telehealth visits * % Completion of lab test * % Survey completion |
| Effectiveness of notifications | 6 months | 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 |
Countries
United States
Outcome results
None listed