Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings (BATMAN)
Predischarge Bundle for Patients in Dual Antiplatelet Therapy to Minimize the Negative Impact of Nuisance Bleedings on Quality of Life: a Randomized Controlled Trial.
研究概览
详细说明
Recent studies suggest that bleeding complications have a strong influence on quality of life. During DAPT regimen bleeding complications occur from 5% to 15% of patients. Nuisance bleedings (BARC 1 bleeding) occur more frequently and show a strong influence on quality of life, depression, anxiety and compliance to the treatment.
The aim of the study is to establish if a specific counseling programme might minimize the negative quality of life impact of nuisance bleedings. A computer-generated list will be used to randomize patients in a 1:1 ratio, stratified by age, sex, renal failure and P2Y12 inhibitor, to either the bundle or the control group.
All patients randomized to the control group (standard of care) will receive education from physician regarding dual antiplatelet therapy (DAPT) as part of the routine discharge process.
All patients randomized to the bundle group will receive:
i) a 15-min visit by a member of the research team 24 h prior to the anticipated discharge day. During this visit, a core set of DAPT risks will be addressed. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.
ii) a 15-min visit by a member of the research team with a family member living near/with the patient. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.
iii) brochure describing advantages, side effects and management of dual antiplatelet therapy. Contemporaneously, the investigators of the study will contact directly by phone and/or mail the general practionnaire of the patient to describe and explain the same topics and the clinical problem of her patient.
iv) availability of phone number to discuss potential side effects of DAPT. In addition, the study coordinator of the study will contact two times by month the patient by phone to assess DAPT compliance and potential BARC 1 bleedings.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ferrara
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Cona、Ferrara、意大利、44124
- University Hospital Of Ferrara
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- signed written informed consent
- hospital admission for ischemic heart disease with clinical indication to coronary artery angiography
- percutaneous coronary intervention and drug eluting stent implantation
- indication to dual antiplatelet therapy for at least 6 months
Exclusion Criteria:
- oral anticoagulant therapy
- bleeding event in the 30 days before the enrolment
- planned surgery
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：good clinical practice
all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process
|
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
其他名称：
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|
实验性的：bundle group
patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)
|
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
quality of life
大体时间：1 month
|
quality of life assessment in each patient by EQ-5D questionnaire
|
1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
emergency room admission
大体时间：1 month
|
number of access to emergency room service for bleeding
|
1 month
|
|
general practitioner visit
大体时间：1 month
|
number of access to general practitioner for bleeding
|
1 month
|
|
dyspnea occurrence
大体时间：1 month
|
number of patients suffering dyspnoea stratified according P2Y12 inhibitors
|
1 month
|
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bleeding academic research consortium (BARC) 2-3
大体时间：1 month
|
occurrence of BARC 2-3 complications
|
1 month
|
|
bleeding academic research consortium (BARC) 1
大体时间：1 month
|
occurrence of BARC 1 complications
|
1 month
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ischemic adverse events
大体时间：1 year
|
cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke
|
1 year
|
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all-cause mortality
大体时间：1 year
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occurrence of all-cause death
|
1 year
|
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BARC 1-3
大体时间：1 year
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occurrence of BARC1-3 complications
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1 year
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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