Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

October 25, 2018 updated by: Janssen Scientific Affairs, LLC

smartADHERE - Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, 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
    • Florida
      • Pensacola, Florida, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Michigan
      • Saint Joseph, Michigan, United States
    • Nevada
      • Reno, Nevada, 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
    • Ohio
      • Canton, Ohio, United States
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
      • Reading, Pennsylvania, United States
      • Yardley, Pennsylvania, United States
    • Tennessee
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
    • Washington
      • Bellevue, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Care4Today®
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 6
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.
Month 6
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.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Scientific Affairs, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2016

Primary Completion (Actual)

March 22, 2018

Study Completion (Actual)

March 22, 2018

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108260
  • 39039039AFL4010 (Other Identifier: Janssen Scientific Affairs, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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