Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation
NCT ID: NCT02996435
Last Updated: 2018-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
139 participants
INTERVENTIONAL
2016-12-21
2018-03-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Mobile Adherence Platform
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.
Mobile Application Intervention
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.
Control: Standard of Care
Participants will receive physician- or nurse-guided standard of care for their rivaroxaban adherence. No drug will be administered as part of this study.
No Intervention
Participants will receive physician- or nurse-guided standard of care.
Interventions
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Mobile Application Intervention
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.
No Intervention
Participants will receive physician- or nurse-guided standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Taking newly-prescribed rivaroxaban for atrial fibrillation for less than or equal to (\<=) 90 days or who are about to initiate therapy (with a prescription dated in the last 90 days)
* At least 1 of the 4 questions answered "yes" from the four-item Morisky Medication Adherence Scale (MMAS-4)
* Possession of a compatible smartphone with an active phone number, text and data plan. The smartphone must be in continued possession of the participant. It may not be a shared device and must exclusively remain in the possession of the participant during the study period. The smartphone must have an active cellular phone number and cellular data subscription. WiFi internet capability is not a substitute for an active cellular data plan
* Willing to have the adherence application installed on a smartphone and use it every day during the entire study period
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study and is willing to authorize the study team to contact the participant's pharmacy for oral anticoagulation medication and refill data
* Willing to provide oral confirmation indicating that he/she has not previously used a medication adherence application
* Ability to read and understand English
Exclusion Criteria
* Anticipated rivaroxaban use less than (\<) 12 months based on clinical documentation or participant interview
* Prescribed rivaroxaban for indications other than atrial fibrillation (Prescriptions for concomitant conditions are allowed as long as 1 of the indications is atrial fibrillation)
* Current use of: specialized anticoagulation clinics for rivaroxaban medication management; specialized pharmacist-led adherence or refill monitoring; or enrollment in a medication adherence program even if that program is for medications other than rivaroxaban
* Current use of adherence tracking devices, hardware, smartphone or computer applications, including but not limited to smart pill bottles, pill timers, radiofrequency tagged medications or dispensers, mobile applications, or automated phone reminders. Pharmacy and health care plan automated refill reminders are permitted and are not exclusion. Pill organizers or containers that only compartmentalize a participant's medications based on days of the week are not exclusion. Pill organizers that remind participants when to take medicine with beeps or alerts are exclusion
* Cognitive, visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone
* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
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Anchorage, Alaska, United States
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
Countries
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References
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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.
Other Identifiers
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39039039AFL4010
Identifier Type: OTHER
Identifier Source: secondary_id
CR108260
Identifier Type: -
Identifier Source: org_study_id
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