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Trial record 1 of 1 for:    02996435
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Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02996435
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : October 26, 2018
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Behavioral: Mobile Application Intervention Other: No Intervention Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: smartADHERE - Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation
Actual Study Start Date : December 21, 2016
Actual Primary Completion Date : March 22, 2018
Actual Study Completion Date : March 22, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: Care4Today®

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.
Other: No Intervention
Participants will receive physician- or nurse-guided standard of care.

Primary Outcome Measures :
  1. Proportion of Days Covered (PDC) [ Time Frame: Month 6 ]
    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.

Secondary Outcome Measures :
  1. Percentage of Participants With PDC Greater Than or Equal to (>=) 80 Percent [ Time Frame: Month 6 ]
    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.

  2. Change From Baseline in the Average Score on the Eight-item Morisky Medication Adherence Scale (MMAS-8) [ Time Frame: Month 6 ]
    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.

  3. Measure of Medication Persistence of Rivaroxaban [ Time Frame: Month 6 ]
    Measure of medication persistence of rivaroxaban defined as the percentage of participants on rivaroxaban with an active prescription at 6 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A history of atrial fibrillation
  • 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 inability to adhere to the mobile application (Care4Today) based on opinion of site Principal Investigator (PI)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02996435

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United States, Alaska
Anchorage, Alaska, United States
United States, California
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
United States, Florida
Pensacola, Florida, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Michigan
Saint Joseph, Michigan, United States
United States, Nevada
Reno, Nevada, United States
United States, New York
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
United States, Ohio
Canton, Ohio, United States
United States, Pennsylvania
Doylestown, Pennsylvania, United States
Reading, Pennsylvania, United States
Yardley, Pennsylvania, United States
United States, Tennessee
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
United States, Washington
Bellevue, Washington, United States
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
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Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
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Responsible Party: Janssen Scientific Affairs, LLC Identifier: NCT02996435    
Other Study ID Numbers: CR108260
39039039AFL4010 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes