Patient and Physician Knowledge of Key Safety Messages
Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages
2 other identifiers
observational
2,227
4 countries
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedStudy Start
First participant enrolled
September 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2020
CompletedApril 8, 2021
April 1, 2021
5.4 years
June 12, 2013
April 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire
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
Up to 18 months
Study Arms (2)
Group 1
Survey to measure physician awareness and understanding of the key messages in the prescriber guide.
Group 2
Survey to measure patient awareness and understanding of the key messages in the patient card.
Interventions
Survey to measure physician awareness and understanding of the key messages in the prescriber guide.
Eligibility Criteria
Physicians of various specialties; patients treated in primary care and specilized clinical practices.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Janssen Research & Development, LLCcollaborator
- RTI Health Solutionscollaborator
Study Sites (4)
Unknown Facility
Multiple Locations, France
Unknown Facility
Multiple Locations, Germany
Unknown Facility
Multiple Locations, Spain
Unknown Facility
Multiple Locations, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2013
First Posted
July 24, 2013
Study Start
September 15, 2014
Primary Completion
February 21, 2020
Study Completion
April 15, 2020
Last Updated
April 8, 2021
Record last verified: 2021-04