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

NCT02819791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2022-02-14

No results posted yet for this study

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

Interventions

OTHER

Optimized conventional therapy alone

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

BEHAVIORAL

Optimized conventional therapy with therapeutic education

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Louis-Rachid SALMI, Pr · Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique du CHU de Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-05
Primary Completion
2017-04-14
Completion
2017-04-14

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02819791 on ClinicalTrials.gov