Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

NCT02996435 | Completed Phase 4

• 2 other identifiers: CR10826039039039AFL4010
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 25

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percentage of Participants With PDC Greater Than or Equal to (>=) 80 Percent

  Month 6

• Change From Baseline in the Average Score on the Eight-item Morisky Medication Adherence Scale (MMAS-8)

  Month 6

• Measure of Medication Persistence of Rivaroxaban

  Month 6

Study Arms (2)

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.

Behavioral: Mobile Application Intervention

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.

Other: No Intervention

Interventions

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.

Also known as: Care4Today®

Mobile Adherence Platform

No Intervention OTHER

Participants will receive physician- or nurse-guided standard of care.

Control: Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead

Study Sites (25)

Unknown Facility

Anchorage, Alaska, United States

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Los Angeles, California, United States

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Manhattan Beach, California, United States

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Oakland, California, United States

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Pasadena, California, United States

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Stanford, California, United States

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Ventura, California, United States

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Pensacola, Florida, United States

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Overland Park, Kansas, United States

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Lexington, Kentucky, United States

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Saint Joseph, Michigan, United States

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Reno, Nevada, United States

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Buffalo, New York, United States

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Jamaica, New York, United States

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Lake Success, New York, United States

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Mineola, New York, United States

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Saratoga Springs, New York, United States

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Canton, Ohio, United States

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Doylestown, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Bellevue, Washington, United States

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Related Publications (1)

• 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.

  PMID: 33676886 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: December 21, 2016
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

US (25)