Study of the Efficiency of Education About Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
A Network to Control Risk Factors After Acute Coronary Syndrome
研究概览
详细说明
Objectives
- The main purpose of this study is to evaluate the efficiency of "Resicard Prevention", which is a structured health network within a House of Education located outside of the hospital and based on outpatients' visits.
- Another purpose is to facilitate and optimize physicians and all health members communication around the acute coronary syndrome patients.
Method
After randomization, patients are directed to one of the two following groups: the conventional network group or the structured network group. Six and twelve months after their hospitalization, a blood test will be performed and their weight, blood pressure, waist measurement and cardiac frequency will be recorded in order to monitor patients' cardiovascular risk factors.In any case, patients receive optimal care with the participation of different health members (such as nurses, doctors, dietician...).
a-The conventional network group
Patients are taken care of, according to good medical practice by their usual general practitioner and cardiologist. The frequency of consultations is set up according to symptoms. The follow up of patients is optimized as they are taken care of by a multidisciplinary health team.
b-The structured network group
- Patients in this group will have to consult their general practitioner and cardiologist within the first month after their hospitalization. Two forms summarizing their hospitalization facts and the objectives of the risk factors correction will be electronically sent to their general practitioner, to their cardiologist and to the House of Education. Patients have appointments at the House of Education where a multidisciplinary team (with a nurse, a dietician,...) welcomes them. They set up a schedule according to patients' needs:
- consultation for nicotinic weaning
- some dietary advice in order to lose weight
- some specific advice on diabetes and/or hypercholesteremia
- information about high blood pressure
- some advice to pursue a regular physical activity After each appointment at the House of Education, a form summarizing the risk factors will be provided electronically to patients' general practitioner and cardiologist.
- Conclusion -This evaluation protocol should demonstrate the efficiency of a health network based on the correction of modifiable cardiovascular risk factors within a House of Education in secondary prevention after an acute coronary syndrome.
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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Aubervilliers、法国、93300
- Clinique la Roseraie
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Paris、法国、75010
- Hopital Lariboisiere
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Paris、法国、75020
- Hopital Tenon
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Paris、法国、75013
- Hopital Pitié Salpetriere
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Paris、法国、75018
- Hôpital Bichat
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Paris、法国、75011
- Hôpital Saint Antoine
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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:
- age > 18 years
- hospitalization for acute coronary syndrome (ST segment elevation myocardial infarction, non-ST segment elevation myocardial infarction, unstable angina)
- cardiovascular risk factors during hospitalization (active and current smoking, sedentary lifestyle, obesity, overweight)
- autonomy
- agreement to visit the House of Education
- signature of a assent
Exclusion Criteria:
- lack of understanding or phrasing
- refusal to sign the consent form
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 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 |
---|---|
无干预:conventional
This arm is the conventional way of taking care of patients after an acute coronary syndrome
|
|
有源比较器:structured
This arm is an active way to monitor and educate patients after their acute coronary syndrome, with the intervention of health members in a House of Education
|
education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
nicotinic weaning
大体时间:1year
|
1year
|
weight loss at least 5%
大体时间:1 year
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1 year
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waist reduction at least 4%
大体时间:1 year
|
1 year
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physical activity at least 30 minute per day (3h per week)
大体时间:1 year
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
correction of nicotinic addiction, overweigh and lack of physical activity all together
大体时间:1 year
|
1 year
|
|
correction of each risk factor of primary outcome, individually
大体时间:1 year
|
1 year
|
|
correction of the other risk factors
大体时间:1 year
|
arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l
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1 year
|
diabetes mellitus with HbA1C inferior to 7%
大体时间:1 year
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1 year
|
|
quality of life with mental and physical scores (SF-12)
大体时间:1 year
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1 year
|
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patient's level of knowledge of the disease: number of correct answers to 19 questions
大体时间:1 year
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1 year
|
合作者和调查者
赞助
调查人员
- 首席研究员:Ariel Cohen, Pr、Hopital St Antoine
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
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 (估计)
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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