ETIC (Therapeutic Education in Heart Failure)

Summary

Use lay language. Background: Heart failure is an increasingly frequent current pathology due to the population aging and the improvement of acute and chronic heart failure management. Heart failure patients have a poor quality of life because of their symptoms (asthenia, dyspnea…) and frequent hospitalizations. Heart failure is an expensive disease: 1.5 % of the health expenses, 85 % in hospital cost with 200 000 hospitalizations in France per year. Previous studies were multidisciplinary interventions and not realistic in a daily practice for a general practitioner. The aim of this project is to integrate therapeutic education for heart failure patients in a current practice. The patient becomes competent to manage his disease and to identify acute heart failure signs.

Main objective: Improve therapeutic education efficiency on life quality of heart failure patients in general practice.

Second objectives: Describe heart failure patient's hospitalizations.

Methods: Cluster randomized controlled clinical trial comparing intervention and control groups with a follow through for 19 months for each patient. A therapeutic education program will be proposed to the heart failure patients in primary care. The intervention group GP will follow a workshop concerning the therapeutic education concepts and the intervention.

Endpoints: Life quality evaluation (SF-36 and Minnesota scales) and number of hospitalizations of patients in each group.

Population: Heart failure patients in stages I, II, and III of NYHA in primary care. Cluster randomized surgeries in Auvergne (France).

Expected results: The therapeutic education allows the patients to improve their quality of life, to be able to detect their illness signs worsening in a early manner, and to contact their doctor if needed. This would limit the acute heart failure due to treatment adaptation or life habits.

Conditions

• Heart Failure
• Quality of Life

Interventions

PROCEDURE

Therapeutic education

Improve therapeutic education efficiency on life quality of heart failure patients in general practice

Sponsors & Collaborators

• GRSP : Groupement Régional de Santé Publique

  collaborator UNKNOWN

• URML : Union Régionale des Médecins Libéraux

  collaborator UNKNOWN

• Ministry of Health, France

  collaborator OTHER_GOV

• URCAM : Union Régionale des Caisses d'Assurances Maladies

  collaborator UNKNOWN

• Sanofi

  collaborator INDUSTRY

• Groupe Pasteur Mutualité

  collaborator UNKNOWN

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Hélène Vaillant-Roussel, MD · University Hospital, Clermont-Ferrand

Study Design

Allocation

RANDOMIZED

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2014-07-31

Countries

• France

Study Locations