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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Aubervilliers、フランス、93300
- Clinique la Roseraie
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Paris、フランス、75010
- Hôpital Lariboisière
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Paris、フランス、75020
- Hopital Tenon
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Paris、フランス、75013
- Hopital Pitie Salpetriere
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Paris、フランス、75018
- Hopital Bichat
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Paris、フランス、75011
- Hôpital Saint Antoine
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:conventional
This arm is the conventional way of taking care of patients after an acute coronary syndrome
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|
アクティブコンパレータ: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
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
nicotinic weaning
時間枠:1year
|
1year
|
weight loss at least 5%
時間枠:1 year
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1 year
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waist reduction at least 4%
時間枠:1 year
|
1 year
|
physical activity at least 30 minute per day (3h per week)
時間枠:1 year
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
correction of nicotinic addiction, overweigh and lack of physical activity all together
時間枠:1 year
|
1 year
|
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correction of each risk factor of primary outcome, individually
時間枠:1 year
|
1 year
|
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correction of the other risk factors
時間枠:1 year
|
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%
時間枠:1 year
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1 year
|
|
quality of life with mental and physical scores (SF-12)
時間枠:1 year
|
1 year
|
|
patient's level of knowledge of the disease: number of correct answers to 19 questions
時間枠:1 year
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1 year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Ariel Cohen, Pr、Hopital St Antoine
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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