- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00337480
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Aubervilliers, 프랑스, 93300
- Clinique la Roseraie
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Paris, 프랑스, 75010
- Hôpital Lariboisière
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Paris, 프랑스, 75020
- Hôpital Tenon
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Paris, 프랑스, 75013
- Hôpital Pitie Salpétrière
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Paris, 프랑스, 75018
- Hôpital Bichat
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Paris, 프랑스, 75011
- Hopital Saint Antoine
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: conventional
This arm is the conventional way of taking care of patients after an acute coronary syndrome
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활성 비교기: 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
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education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
nicotinic weaning
기간: 1year
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1year
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weight loss at least 5%
기간: 1 year
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1 year
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waist reduction at least 4%
기간: 1 year
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1 year
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physical activity at least 30 minute per day (3h per week)
기간: 1 year
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
correction of nicotinic addiction, overweigh and lack of physical activity all together
기간: 1 year
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1 year
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correction of each risk factor of primary outcome, individually
기간: 1 year
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1 year
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correction of the other risk factors
기간: 1 year
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arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l
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1 year
|
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diabetes mellitus with HbA1C inferior to 7%
기간: 1 year
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1 year
|
|
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quality of life with mental and physical scores (SF-12)
기간: 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
기간: 1 year
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1 year
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Ariel Cohen, Pr, Hôpital St Antoine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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