Patient and Physician Knowledge of Key Safety Messages

Study Description

Brief Summary

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 Date	June 12, 2013
Last Update Posted Date	February 13, 2018
Actual Start Date	September 15, 2014
Anticipated Completion Date	March 15, 2019
Actual Primary Completion Date	December 15, 2018
Results First Submitted Date	N/A
Received Results Disposit Date	N/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

Current Secondary Outcome Measures

Original Secondary Outcome Measures

Study Design

Brief Title	Patient and Physician Knowledge of Key Safety Messages
Official Title	Xarelto (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 Type	Observational
Study Phase	N/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 Method	Non-Probability Sample
Study Population	Physicians 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) 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.

Recruitment Information

Recruitment Status:	Recruiting
Enrollment	500
Completion Date	March 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.
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Bayer Clinical Trials Contact [email protected]
Listed Location Countries	France Germany Spain United Kingdom

Administrative Information

NCT Number:	NCT01907048
Other Study ID Numbers	16167 XA1202
Has Data Monitoring Committee	No
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