StrokeETHEPATNCT02819791
Impact of a Therapeutic Education Program of Patient on the Evolution of the Cardiovascular Chronic Disease
A study testing Optimized conventional therapy alone and Optimized conventional therapy with therapeutic education in people with Stroke and Myocardial Infarction, run by University Hospital, Bordeaux at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Myocardial Infarction
- What is being tested?
- Optimized conventional therapy alone and Optimized conventional therapy with therapeutic education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2014to 14 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized for a cardiovascular event (myocardial infarction); Neurovascular attack (TIA or stroke)
- Patients whose age is between 18 and 75 years
- Patients who signed the informed consent after information about the study
Who cannot join
- Subject participating or having participated in another study that alters conventional management of hospitalized patients for stroke, transient ischemic attack or myocardial infarction
- Significant cognitive troubles making transmission of questionnaire impossible, or speech or understanding disorders (including non francophone patients)
Trial locations and contacts
1 site in 1 country.
France1 site
CEPTA (Centre d'Exploration, de Prévention et de Traitement de l'Athérosclérose), Hôpital Cardiologique du Haut-Lévêque
Pessac, 33604
About this study
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.
Read the 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.
- Conditions
- Stroke, Myocardial Infarction
- Being tested
- Optimized conventional therapy alone, Optimized conventional therapy with therapeutic education
- Keywords
- Cardiovascular, therapeutic education
- Medical subject headings
- Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized conventional therapy aloneOther
Patients will benefit from a traditional follow-up as provided for this type of patients at 3 months and 1 year
Optimized conventional therapy with therapeutic educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: Optimized conventional therapy alone |
| Intervention group | Experimental | Not described Receives: Other: Optimized conventional therapy alone; Behavioral: Optimized conventional therapy with therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference measure of the risk factors score between baseline and 1 year of follow-up
The sum of the different risk factors score is calculated at the baseline and the year 1. Then the difference between both is calculated.
Measured: Baseline to year 1
Secondary outcomes (2)
Assessment of the improvement of at least one point of the risk score between baseline and 1 year of follow-up
Each risk factor score is compared individually at the baseline and the year 1 to assess if at least one risk factor score improved from the Baseline (success or failure).
Measured: Baseline to year 1
Measure of the Framingham score giving a risk prediction of recurrent cardiovascular event
Measured: Day 1, month 3, year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start5 Jun 2014
- Primary completion14 Apr 2017
- Study completion14 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis-Rachid SALMI, Pr, Study chair, Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819791
- Sponsor's protocol ID
- CHUBX 2013/21
- Other IDs
- 2013-A01716-39
- Acronym
- ETHEPAT
- Status last verified
- Feb 2022
- First submitted
- 28 Jun 2016
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Therapeutic Education Program of Patient on the Evolution of the Cardiovascular Chronic Disease
- ClinicalTrials.gov ID
- NCT02819791
- Acronym / sponsor ID
- ETHEPAT / CHUBX 2013/21
- Conditions
- Stroke, Myocardial Infarction
- Keywords
- Cardiovascular, therapeutic education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Jun 2014 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 14 Apr 2017 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Optimized conventional therapy alone |
| Intervention group | Experimental | Other: Optimized conventional therapy alone, Behavioral: Optimized conventional therapy with therapeutic education |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients hospitalized for a cardiovascular event (myocardial infarction); Neurovascular attack (TIA or stroke)
- Patients whose age is between 18 and 75 years
- Patients who signed the informed consent after information about the study
Key exclusion criteria (2 listed)
- Subject participating or having participated in another study that alters conventional management of hospitalized patients for stroke, transient ischemic attack or myocardial infarction
- Significant cognitive troubles making transmission of questionnaire impossible, or speech or understanding disorders (including non francophone patients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized conventional therapy alonePatients will benefit from a traditional follow-up as provided for this type of patients at 3 months and 1 year | Other | Control group, Intervention group |
| Optimized conventional therapy with therapeutic educationThe 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. | Behavioural | Intervention group |
Primary outcome
Difference measure of the risk factors score between baseline and 1 year of follow-up
Time frame: Baseline to year 1
The sum of the different risk factors score is calculated at the baseline and the year 1. Then the difference between both is calculated.
2 secondary outcomes
Assessment of the improvement of at least one point of the risk score between baseline and 1 year of follow-up
Time frame: Baseline to year 1
Measure of the Framingham score giving a risk prediction of recurrent cardiovascular event
Time frame: Day 1, month 3, year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis-Rachid SALMI, Pr study chair
Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized conventional therapy alone and Optimized conventional therapy with therapeutic education in people with Stroke and Myocardial Infarction, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference measure of the risk factors score between baseline and 1 year of follow-up (time frame: Baseline to year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.