Smartphones to Improve Rivaroxaban ADHEREnce in Atrial Fibrillation

NCT02996435 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2018-10-26

No results posted yet for this study

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

Interventions

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

No Intervention

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

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-21
Primary Completion
2018-03-22
Completion
2018-03-22

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02996435 on ClinicalTrials.gov