ETIC (Therapeutic Education in Heart Failure)

NCT01065142 | Unknown

• 2 other identifiers: CHU-00672009-A01142-55
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heart Failure; Patient Education as Topic; Primary Health Care; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Life quality evaluation of both groups (control and intervention) at 0, 7, 13, and 19 months from the beginning of the inclusion filled in by the patient or his/her main caregiver (husband or wife, a friend...) thanks to a closed envelope given by the GP

  at 0, 7, 13 and 19 months from the beginning of the incusion

Secondary Outcomes (1)

• Collection of the number and the duration of hospital readmission for worsening heart failure and for all cause hospital readmission and of the total number of days of hospitalisation during the follow-up period.

  during the follow-up period

Interventions

Therapeutic education PROCEDURE

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Investigators: volunteer randomized general practitioners from the Auvergne region in France.
• The GPs will be randomized in cluster, each GP should recruit at least five patients. If several doctors are part of the same surgery, they will be randomized in the same group (intervention or control). The randomization of the GPs will be stratified by department. The GP commit themselves not to talk of the study between them. Each GP knows in which group of the study he belongs as the intervention group comprises a training seminar but the objectives of the study will not be known by the GPs of the control group.
• Patients: Systolic or diastolic HF patients to the stages I, II and III of the NYHA followed in primary care. These patients will be recruited by the randomized GP in the intervention and control groups. Patients should be over 50 years old (this age limit expelled only few patients with particular pathology).

You may not qualify if:

• Are not included the stage IV, with short life expectancy, with low efficiency hope of the tested measure, who are very few. The systolic and diastolic HF patients are not distinguished because the possible efficiency of the intervention is not HF type dependent a priori.
• Dementia as Alzheimer disease diagnosed by GP.
• Already included in another study
• Incapacity to follow the education sessions (language problem...)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• GRSP : Groupement Régional de Santé Publique: collaborator
• URML : Union Régionale des Médecins Libéraux: collaborator
• Ministry of Health, France: collaborator
• URCAM : Union Régionale des Caisses d'Assurances Maladies: collaborator
• Sanofi: collaborator
• Groupe Pasteur Mutualité: collaborator

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

• Vaillant-Roussel H, Laporte C, Pereira B, De Rosa M, Eschalier B, Vorilhon C, Eschalier R, Clement G, Pouchain D, Chenot JF, Dubray C, Vorilhon P. Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial. BMC Fam Pract. 2016 Jul 19;17:80. doi: 10.1186/s12875-016-0473-4.

  PMID: 27436289 DERIVED

• Vaillant-Roussel H, Laporte C, Pereira B, Tanguy G, Cassagnes J, Ruivard M, Clement G, Le Reste JY, Lebeau JP, Chenot JF, Pouchain D, Dubray C, Vorilhon P. Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial. BMC Fam Pract. 2014 Dec 24;15:208. doi: 10.1186/s12875-014-0208-3.

  PMID: 25539989 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hélène Vaillant-Roussel, MD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: April 1, 2011
• Primary Completion: July 1, 2014
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

FR (1)