Impact of a Therapeutic Education Program of Patient on the Evolution of the Cardiovascular Chronic Disease

NCT02819791 | Completed

• 2 other identifiers: CHUBX 2013/212013-A01716-39
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Myocardial Infarction

Keywords

Cardiovascular; therapeutic education

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline to year 1

• Measure of the Framingham score giving a risk prediction of recurrent cardiovascular event

  Day 1, month 3, year 1

Study Arms (2)

Control group

ACTIVE COMPARATOR

Other: Optimized conventional therapy alone

Intervention group

EXPERIMENTAL

Other: Optimized conventional therapy alone; Behavioral: Optimized conventional therapy with therapeutic education

Interventions

Optimized conventional therapy alone OTHER

Patients will benefit from a traditional follow-up as provided for this type of patients at 3 months and 1 year

Control group; Intervention group

Optimized conventional therapy with therapeutic education BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CEPTA (Centre d'Exploration, de Prévention et de Traitement de l'Athérosclérose), Hôpital Cardiologique du Haut-Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Stroke; Myocardial Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Louis-Rachid SALMI, Pr

  Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: June 5, 2014
• Primary Completion: April 14, 2017
• Study Completion: April 14, 2017
• Last Updated: June 1, 2026

Record last verified: 2022-02

Locations

FR (1)