Study of the Efficiency of Education About Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00337480|
Recruitment Status : Completed
First Posted : June 16, 2006
Last Update Posted : April 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Behavioral: education||Not Applicable|
- 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||504 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Network to Control Risk Factors After Acute Coronary Syndrome|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||September 2009|
No Intervention: conventional
This arm is the conventional way of taking care of patients after an acute coronary syndrome
Active Comparator: 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
- nicotinic weaning [ Time Frame: 1year ]
- weight loss at least 5% [ Time Frame: 1 year ]
- waist reduction at least 4% [ Time Frame: 1 year ]
- physical activity at least 30 minute per day (3h per week) [ Time Frame: 1 year ]
- correction of nicotinic addiction, overweigh and lack of physical activity all together [ Time Frame: 1 year ]
- correction of each risk factor of primary outcome, individually [ Time Frame: 1 year ]
- correction of the other risk factors [ Time Frame: 1 year ]arterial hypertension inferior to 140/90 Hgmm; low density lipoprotein cholesterol inferior to 1g/l
- diabetes mellitus with HbA1C inferior to 7% [ Time Frame: 1 year ]
- quality of life with mental and physical scores (SF-12) [ Time Frame: 1 year ]
- patient's level of knowledge of the disease: number of correct answers to 19 questions [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337480
|Clinique la Roseraie|
|Aubervilliers, France, 93300|
|Paris, France, 75010|
|Hopital Saint Antoine|
|Paris, France, 75011|
|Hopital Pitie Salpetriere|
|Paris, France, 75013|
|Paris, France, 75018|
|Paris, France, 75020|
|Principal Investigator:||Ariel Cohen, Pr||Hopital St Antoine|