Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02433366
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.

Detailed Description

Purpose:

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-07
• Results First Submitted: 2016-07-28
• Results First Submitted QC: 2016-07-28
• Last Update Submitted: 2016-07-28
• Results First Posted: 2016-09-19
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1213

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)	Day 1	The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.; This Outcome measure is applicable only for the Physicians group.
Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)	Day 1	The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.

Trial Locations

Locations (161)

Boehringer Ingelheim Investigational Site 81; 🇧🇬 Dobritch, Bulgaria

Boehringer Ingelheim Investigational Site 84; 🇧🇬 Gabrovo, Bulgaria

Boehringer Ingelheim Investigational Site 79; 🇧🇬 Montana, Bulgaria

Boehringer Ingelheim Investigational Site 85; 🇧🇬 Plovdiv, Bulgaria

Boehringer Ingelheim Investigational Site 80; 🇧🇬 Shumen, Bulgaria

Boehringer Ingelheim Investigational Site 86; 🇧🇬 Sliven, Bulgaria

Boehringer Ingelheim Investigational Site 87; 🇧🇬 Sofia, Bulgaria

Boehringer Ingelheim Investigational Site 88; 🇧🇬 Stara Zagora, Bulgaria

Boehringer Ingelheim Investigational Site 82; 🇧🇬 Varna, Bulgaria

Boehringer Ingelheim Investigational Site 83; 🇧🇬 Veliko Tarnovo, Bulgaria

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