Patient and Physician Knowledge of Key Safety Messages

ID: NCT01907048
Status: Recruiting
Phase: N/A
Start Date: September 15, 2014
First Submitted: June 12, 2013
Last Updated: February 13, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer, Janssen Research & Development, LLC, RTI Health Solutions
Location: France, Germany, Spain, United Kingdom
Conditions: Anticoagulation
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Study Description

Brief Summary

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

Detailed Description

Condition or disease Intervention/treatment Phase

Anticoagulation

Behavioral: Rivaroxaban (Xarelto, BAY59-7939)
Other Names
Behavioral: Rivaroxaban (Xarelto, BAY59-7939)
Other Names
N/A

Tracking Information

First Submitted DateJune 12, 2013
Last Update Posted DateFebruary 13, 2018
Actual Start DateSeptember 15, 2014
Anticipated Completion DateMarch 15, 2019
Actual Primary Completion DateDecember 15, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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]

  • 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]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitlePatient and Physician Knowledge of Key Safety Messages
Official TitleXarelto (Rivaroxaban) - Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages
Brief Summary

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

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
500
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Anticoagulation
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationPhysicians of various specialties; patients treated in primary care and specilized clinical practices.
Intervention
Behavioral: Rivaroxaban (Xarelto, BAY59-7939)

Survey to measure physician awareness and understanding of the key messages in the prescriber guide.

Other Names
Behavioral: Rivaroxaban (Xarelto, BAY59-7939)

Survey to measure patient awareness and understanding of the key messages in the patient card.

Other Names
Study Groups/Cohorts
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.

Study Arms
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.

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 patient awareness and understanding of the key messages in the patient card.

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

Recruitment Information

Recruitment Status:Recruiting
Enrollment500
Completion DateMarch 15, 2019
Eligibility Criteria: - Inclusion criteria:
- 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
France
Germany
Spain
United Kingdom

Administrative Information

NCT Number:NCT01907048
Other Study ID Numbers
16167
XA1202
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
RTI Health Solutions
Investigators
Study Director
Bayer Study Director
Bayer