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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.
Objectives
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional | No Intervention | This arm is the conventional way of taking care of patients after an acute coronary syndrome | |
| structured | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| education | Behavioral | education of acute coronary syndrome patients, mostly about nicotinic weaning, weight loss and physical activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| nicotinic weaning | 1year | |
| weight loss at least 5% | 1 year | |
| waist reduction at least 4% | 1 year | |
| physical activity at least 30 minute per day (3h per week) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel Cohen, Pr | Hopital St Antoine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique la Roseraie | Aubervilliers | 93300 | France | |||
| Hopital Lariboisiere |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24126705 | Derived | Cohen A, Assyag P, Boyer-Chatenet L, Cohen-Solal A, Perdrix C, Dalichampt M, Michel PL, Montalescot G, Ravaud P, Steg PG, Boutron I; Reseau Insuffisance Cardiaque (RESICARD) PREVENTION Investigators. An education program for risk factor management after an acute coronary syndrome: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):40-8. doi: 10.1001/jamainternmed.2013.11342. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D012907 | Smoking |
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| correction of the other risk factors |
arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l |
| 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 |
| Paris |
| 75010 |
| France |
| Hopital Saint Antoine | Paris | 75011 | France |
| Hopital Pitie Salpetriere | Paris | 75013 | France |
| Hopital Bichat | Paris | 75018 | France |
| Hopital Tenon | Paris | 75020 | France |
| D001519 |
| Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |