Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The occurence of serious adverse event
研究概览
简要总结
This study is multicentric, single-blind, and interventional with a randomization into two parallel arm, between a standard of care information and an additional information of the patient, with a 12 month follow up.
The aim of this study is to evaluate the effectiveness of a personalized information program versus information provided from standard of care in patients taking Xarelto for Stroke Prevention in Atrial Fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients treated with rivaroxaban chronically, (atrial fibrillation non-valvular under current AMM) for less than one year whatever anti vitamin K treatment history
- •Affiliate or beneficiary of a social security system.
- •Patient who formulated its "does not oppose" to participate in this research
- •Age higher than or equal to 18 years
排除标准
- •Opposition to participation
- •Patient don't understand french language
- •Patient does not have responsibility for the management of treatment (treatment administered by a nurse at home, or by caregivers)
- •Tutorship or curatoship
- •Law-protected patient
- •Pregnant women or breast-feeding
研究组 & 干预措施
Taking conventional charge
No further information is given to the patient during the first and only contact with the nurse of the coordinator center. A time will be dedicated by the IDE to answer questions of the patient.
干预措施: Xarelto (Drug)
结局指标
主要结局
The occurence of serious adverse event
时间窗: 12 months
The occurence of serious adverse event
次要结局
- The number ok hospitalization(12 months)
