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临床试验/NCT02433366
NCT02433366已完成不适用

Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF

Boehringer Ingelheim161 个研究点 分布在 4 个国家目标入组 1,213 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,213
试验地点
161
主要终点
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)

研究概览

简要总结

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.

详细描述

Purpose:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (161)

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