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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DeTAP Study App and Home Devices | Experimental | Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of DeTAP App and Home Devices | Behavioral | DeTAP App (data collection, televisit function, information and reminders), Bluetooth-connected 6-lead home (electrocardiogram) EKG device, Bluetooth-connected blood pressure (BP) cuff |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement with study protocol | Composite endpoint of:
| 6 months |
| Effectiveness of notifications | Composite endpoint of:
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Dash, MD PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 35764796 | Result | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |