NCT01033279已完成不适用
Evaluation of Self-monitoring of Oral antiCoagulant therApy by the PatiEnts
Montreal Heart Institute2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Anticoagulation-related quality of life
研究概览
简要总结
The purpose of this study is to determine whether self-management of oral anticoagulation therapy with warfarin has an effect on patient's quality of life following a specific training program led by pharmacists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years and over followed at the Montreal Heart Institute's Anticoagulation clinic
- •Warfarin treatment planned for at least 4 months after inclusion in the study
- •Warfarin treatment initiated for at least 6 months
- •Last 2 INRs between 1.5 and 4 if target INR is between 2 and 3
- •Last 2 INRS between 2 and 4 if target INR is between 2.5 and 3.5
- •Provide a signed informed consent
排除标准
- •Patient unable to understand (spoken and written) French or English
- •Patient refuses or is unable to attend the required training sessions
- •Targeted INR other than 2 to 3 or 2.5 to 3.5
- •Handicap or physical limitation compromising the patient's ability to initiate self-monitoring in the absence of a proxy helper
- •Moderate to severe cognitive impairment or important comprehension problems
- •Active neoplasm
- •Concurrent chemotherapy
- •Hypercoagulable conditions
- •Life expectancy of less than 1 year documented in the medical chart
- •Inclusion (at time of inclusion or 30 days prior to inclusion) in another research project involving a drug
- •Patient anticoagulated with nicoumalone
- •Pregnancy or breastfeeding
- •Active bleeding (except for menses)
- •Recent major bleeding (less than 3 months before inclusion)
- •Stroke, acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, cardiac valve replacement, deep veinous thrombosis or pulmonary embolism in the 3 months prior to inclusion
- •Any other condition that, in the opinion of the investigators, of the treating physician or of the healthcare professionals working at the anticoagulation clinic could make self-management by the patient impossible
结局指标
主要结局
Anticoagulation-related quality of life
时间窗: Four months
次要结局
- Time in therapeutic International Normalized Ratio (INR)(Four months)
- Time in extended therapeutic INR range(Four months)
- Time in extreme INR ranges (<1.5 and > 5)(Four months)
- Evolution of anticoagulation-related knowledge post training program(Four months)
- Time spent by patients managing their oral anticoagulation(Four months)
- Hemorrhagic events(Four months)
- Thromboembolic events(Four months)
研究者
Lucie Verret
Chief Department of Pharmacy
Montreal Heart Institute
研究点 (2)
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