Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02819791 |
| Other study ID # |
CHUBX 2013/21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 5, 2014 |
| Est. completion date |
April 14, 2017 |
Study information
| Verified date |
February 2022 |
| Source |
University Hospital, Bordeaux |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
