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| ID | Type | Description | Link |
|---|---|---|---|
| 39039039AFL4010 | Other Identifier | Janssen Scientific Affairs, LLC |
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The primary purpose of this study is to evaluate the effectiveness of an intervention with a mobile adherence platform, compared to physician- or nurse-guided standard of care, to improve medication adherence to rivaroxaban in participants who have recently initiated treatment with rivaroxaban for stroke prevention in atrial fibrillation based on an assessment of the proportion of days covered (PDC) of rivaroxaban treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Adherence Platform | Experimental | Participant adherence will be monitored using a mobile application and platform which provides a real-time reminder that alerts the participant to take his or her medication. The application will also send an alert to the participant when a refill is needed based on calculated medication or pill supply. The intervention will focus only on daily adherence to rivaroxaban. |
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| Control: Standard of Care | Other | Participants will receive physician- or nurse-guided standard of care for their rivaroxaban adherence. No drug will be administered as part of this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Application Intervention | Behavioral | Mobile phone application that sends reminders and allows participants to self-manage their medication adherence. Monitoring of participant adherence from this tool will be performed by the central coordinating center, which will send notifications or contact the participant based on the adherence history in accordance with the study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Days Covered (PDC) | Adherence to rivaroxaban medication will be estimated based on validated PDC algorithm. PDC (expressed as percentage) defined as non-hospitalized days during which oral anticoagulant (OAC) will be supplied and consumed over total observation time duration during which rivaroxaban should have been consumed. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With PDC Greater Than or Equal to (>=) 80 Percent | PDC defined as non-hospitalized days during which oral anticoagulant (OAC) will be supplied and consumed over total observation time duration during which rivaroxaban should have been consumed. | Month 6 |
| Change From Baseline in the Average Score on the Eight-item Morisky Medication Adherence Scale (MMAS-8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage | Alaska | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33676886 | Derived | Turakhia M, Sundaram V, Smith SN, Ding V, Michael Ho P, Kowey PR, Piccini JP, Foody J, Birmingham MC, Ianus J, Rajmane A, Mahaffey KW; smartADHERE Investigators. Efficacy of a centralized, blended electronic, and human intervention to improve direct oral anticoagulant adherence: Smartphones to improve rivaroxaban ADHEREnce in atrial fibrillation (SmartADHERE) a randomized clinical trial. Am Heart J. 2021 Jul;237:68-78. doi: 10.1016/j.ahj.2021.02.023. Epub 2021 Mar 4. |
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| No Intervention | Other | Participants will receive physician- or nurse-guided standard of care. |
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The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. |
| Month 6 |
| Measure of Medication Persistence of Rivaroxaban | Measure of medication persistence of rivaroxaban defined as the percentage of participants on rivaroxaban with an active prescription at 6 months. | Month 6 |
| Los Angeles |
| California |
| United States |
| Manhattan Beach | California | United States |
| Oakland | California | United States |
| Pasadena | California | United States |
| Stanford | California | United States |
| Ventura | California | United States |
| Pensacola | Florida | United States |
| Overland Park | Kansas | United States |
| Lexington | Kentucky | United States |
| Saint Joseph | Michigan | United States |
| Reno | Nevada | United States |
| Buffalo | New York | United States |
| Jamaica | New York | United States |
| Lake Success | New York | United States |
| Mineola | New York | United States |
| Saratoga Springs | New York | United States |
| Canton | Ohio | United States |
| Doylestown | Pennsylvania | United States |
| Reading | Pennsylvania | United States |
| Yardley | Pennsylvania | United States |
| Memphis | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Bellevue | Washington | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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