Patient and Physician Knowledge of Key Safety Messages

April 5, 2021 updated by: Bayer

Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages

This cross-sectional epidemiologic study measured physician and patient awareness and understanding of the key messages in the Xarelto prescriber guide and Xarelto patient alert card.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2227

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

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

Sampling Method

Non-Probability Sample

Study Population

Physicians of various specialties; patients treated in primary care and specilized clinical practices.

Description

- Inclusion criteria:

Physician eligibility:

  • Prescription of rivaroxaban in the past 6 months for adult patients for the Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (SPAF) or Treatment of deep venous thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT.

Patient eligibility:

  • Use of rivaroxaban for SPAF or DVT within the previous 3 months; aged 18 years and above; able to understand and complete the consent form and patient questionnaire.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Survey to measure physician awareness and understanding of the key messages in the prescriber guide.
Behavioral: Rivaroxaban (Xarelto, BAY59-7939)
Survey to measure physician awareness and understanding of the key messages in the prescriber guide.
Behavioral: Rivaroxaban (Xarelto, BAY59-7939)
Survey to measure patient awareness and understanding of the key messages in the patient card.
Group 2
Survey to measure patient awareness and understanding of the key messages in the patient card.
Behavioral: Rivaroxaban (Xarelto, BAY59-7939)
Survey to measure physician awareness and understanding of the key messages in the prescriber guide.
Behavioral: Rivaroxaban (Xarelto, BAY59-7939)
Survey to measure patient awareness and understanding of the key messages in the patient card.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire
Time Frame: Up to 18 months
Up to 18 months
Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaire
Time Frame: Up to 18 months
Up to 18 months

Collaborators and Investigators

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

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC
RTI Health Solutions

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.

Helpful Links

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)

September 15, 2014

Primary Completion (Actual)

February 21, 2020

Study Completion (Actual)

April 15, 2020

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

July 22, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16167
  • XA1202 (Other Identifier: Company Internal)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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