Patient and Physician Knowledge of Key Safety Messages

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01907048

Collaborator

Janssen Research & Development, LLC (Industry), RTI Health Solutions (Other)

2,227

Enrollment

Locations

Actual Duration (Months)

556.8

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulation	Behavioral: Rivaroxaban (Xarelto, BAY59-7939) Behavioral: Rivaroxaban (Xarelto, BAY59-7939)

Study Design

Study Type:

Observational

Actual Enrollment :

2227 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Sep 15, 2014

Actual Primary Completion Date :

Feb 21, 2020

Actual Study Completion Date :

Apr 15, 2020

Arms and Interventions

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) 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)

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.