A Network to Control Risk Factors After Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 试验地点
- 12
- 主要终点
- waist reduction at least 4%
研究概览
简要总结
The purpose of this study is to determine whether the follow up of patients with acute coronary syndrome and modifiable cardiovascular risk factors is efficient based on outpatients visits in a House of Education, underlining the importance of nicotinic weaning, weight loss and physical activity practice.
详细描述
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Objectives
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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.
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Another purpose is to facilitate and optimize physicians and all health members communication around the acute coronary syndrome patients.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •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)
- •agreement to visit the House of Education
- •signature of a assent
排除标准
- •lack of understanding or phrasing
- •refusal to sign the consent form
结局指标
主要结局
waist reduction at least 4%
时间窗: 1 year
nicotinic weaning
时间窗: 1year
weight loss at least 5%
时间窗: 1 year
physical activity at least 30 minute per day (3h per week)
时间窗: 1 year
次要结局
- correction of nicotinic addiction, overweigh and lack of physical activity all together(1 year)
- correction of each risk factor of primary outcome, individually(1 year)
- correction of the other risk factors(1 year)
- diabetes mellitus with HbA1C inferior to 7%(1 year)
- quality of life with mental and physical scores (SF-12)(1 year)
- patient's level of knowledge of the disease: number of correct answers to 19 questions(1 year)
研究者
Pr Ariel Cohen
professor
Resicard
