Impact of a Therapeutic Education Program of Patient on the Evolution of the Cardiovascular Chronic Disease
Condition: Stroke; Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The Exploration Center for Prevention and Treatment of Atherosclerosis (CEPTA, Bordeaux
      Hospital University) showed that following myocardial infarct (MI) or ischemic stroke (TIA or
      stroke), the global management (medical and educational) of patients led to very long-term
      satisfactory results in terms of reduction of cardiovascular (CV) risk and morbidity and
      mortality. However, the specific effect of therapeutic education beyond the conventional
      treatment has never been an adequate assessment. The following at 1 year of this study will
      show the evolution of chronic long-term CV disease in patients who received therapeutic
      education, and to explain the mechanisms. The challenge of this project is to demonstrate for
      the first time the superiority of therapeutic education and conventional care and propose a
      modeling program for national diffusion.

      Patients who experienced a CV event (MI, stroke) will be randomized into 2 groups of 165
      patients each: 1) receiving conventional treatment alone; 2) receiving conventional treatment
      + CEPTA program. The study was built for a 1-year follow-up period, to demonstrate the impact
      of therapeutic education on evolution of risk factors, physical, psychological and social
      health of patients. The main benefit of this study for the patient is the implementation of
      an optimized treatment and long-term monitoring by a cardiology referral center.
    

Detailed description: 
      Chronic cardiovascular diseases are the second cause of death in France, and represent a
      major public health issue. Recurrences are numerous, due to inadequate control of
      cardiovascular risk factors, despite significant drug prescription. Therapeutic education can
      help to improve the health of patients, physical and psychical.

      The Exploration Center for Prevention and Treatment of Atherosclerosis (CEPTA, Bordeaux
      Hospital University) demonstrated that following myocardial infarction or stroke, the
      comprehensive care (medical and educational) of patients CEPTA led to results very
      satisfactory in terms of reduction of cardiovascular risk and morbidity and mortality.
      However, the specific effect of therapeutic education beyond the conventional treatment has
      never been a proper assessment. This study is a single-center prospective, randomized,
      controlled. The main objective is to find and explain the impact of the "therapeutic
      education program" in addition to optimized conventional therapy in post-MI or stroke
      patients, compared to an optimized conventional therapy alone . Patients will be randomized
      during hospitalization for their acute phase into two groups of 165 patients each. The first
      group receiving conventional therapy alone and the 2nd group receiving conventional treatment
      + the therapeutic education program. All patients benefit from traditional monitoring as
      provided for this type of patients, followed up for 3 months and 1 year.

      In the first days after the acute event, patients benefit from the most appropriate treatment
      and receive guidance for their change in lifestyle, diet and smoking cessation. Optimal
      treatment will be prescribed to the output depending on cardiovascular status and risk
      factors.

      Three months after cardiovascular events, patients will benefit from their assessment of
      atherosclerosis and its consequences on myocardial or neurological functions. Each patient
      will receive an assessment of risk factors (smoking, dietary habits and physical activity).
      Personalized advice will be issued. One participants group will receive the "conventional
      treatment + therapeutic education program (CEPTA program)".

      The objectives of the therapeutic education associate:

        -  Of learning objectives and acquisition of knowledge and self-care skills making the
           patient more autonomous and facilitating its adherence.

        -  the objectives of acquiring coping skills (self-confidence, stress management, setting
           projects) to improve their quality of life.

        -  the development objectives respects the relevant criteria of quality, realism and
           principle of educational progress.

      The challenge of this project is to demonstrate for the first time the superiority of a
      conventional treatment + therapeutic education in this population, and to propose a model
      program for national broadcast.
    

Intervention name(s): Optimized conventional therapy alone; Optimized conventional therapy with therapeutic education
Intervention type(s): Other; Behavioral
Intervention description(s): Patients will benefit from a traditional follow-up as provided for this type of patients at 3 months and 1 year; The objectives of this therapeutic education program involve:
learning objectives and acquisition of knowledge and self-care skills making the patient more autonomous and facilitating its adherence.
the objectives of acquiring coping skills ( self-confidence , stress management , setting projects ) to improve their quality of life .
the development objectives respects the relevant criteria of quality , realism and principle of educational progress.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular; therapeutic education