ETIC (Therapeutic Education in Heart Failure)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
GRSP : Groupement Régional de Santé Publique
URML : Union Régionale des Médecins Libéraux
Ministry of Health, France
URCAM : Union Régionale des Caisses d’Assurances Maladies
Sanofi
Groupe Pasteur Mutualité
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01065142
First received: February 8, 2010
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Heart Failure
Quality of Life
Procedure: Therapeutic education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Does Therapeutic Education Improve Heart Failure Patient Quality of Life?

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 [ Time Frame: at 0, 7, 13 and 19 months from the beginning of the incusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: during the follow-up period ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: April 2011
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Therapeutic education
    Improve therapeutic education efficiency on life quality of heart failure patients in general practice
Detailed Description:

General organisation of the study

  • Recruitment of the GP: 3 months (from January to March 2010)
  • Training of the intervention group GP during a two days workshop in April 2010 on the therapeutic education and the intervention by an expert team
  • Patient Inclusions of by GP: 10 months (from April 2010 to January 2011). The included patients will be followed for 19 months. Some patients will be potentially recruited during the 10th month of inclusion, the follow-up period being of 29 months.
  • First consultation used to the inclusion:

    • Information to the patient and collection of the patient written agreement (without informing the intervention objectives in the control group).
    • Evaluation of the life quality in both groups with the SF-36 scale (general) and the Minnesota scale (HF specific) written by the patient or his/her main caregiver (wife or husband, a friend...) in the waiting room after the consultation thanks to a closed envelope given by the GP containing the questionnaire and a pre-paid envelope.
  • Intervention of the general practitioner to the patients in the scope of a therapeutic education program:

    • In the intervention group: first session (M1) dedicated to the educative diagnosis after one month. Then 4 sessions of standardized therapeutic education and adapted to the patient each three months for one year. One session in M19 will be dedicated to the synthesis of what the patient learnt from these interventions.
    • In the control group: the patient is followed in consultation in the same deadlines without any particular intervention in M1, M4, M7, M10, M13, M19.
  • Life quality evaluation of both groups 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 the end of his consultation) containing the questionnaire and pre-paid envelope. These documents are filled in the waiting room after the first consultation and at home in the 7 days following the other consultations. The life quality will be evaluated at the inclusion time (M0), during the intervention (M7 and M13) and at distance (M19) from the end of the intervention. The Minnesota score (22, 23) has been chosen because it is validated and specific of life quality of HF patients. The SF-36 score has also been retained as it permits a generic and global evaluation of life quality and because its reliability, validity and responsiveness have been established (24) (25) (26). SF-36 is the most widely evaluated quality of life measure between 1990 and 1999 (27).
  • 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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • All the general practitioners in Auvergne (except homeopaths, acupunctures...) will be contacted by mail to inform them about the study and to invite them to participate to it. The volunteer GPs will have to return their written agreement via a pre-stamped envelope to the investigator center with their coordinates. They will be randomized in both groups (intervention and control). After the formation, each GP of the intervention group would have to recruit at least five patients seen in consultation, who could be included and who have given their written agreement. Each week of the inclusion period, the GP will recruit the first patient having the eligibility criteria until the inclusion of at least five patients. The anonymity of the patients will be guaranteed in the participation contract. The data will be anonymized by the investigator GP and will be submitted to the French electronic data liberty commission (Commission Nationale Informatique et Libertés (CNIL)). The patients could quit the study at any time.

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).

Exclusion Criteria:

  • • 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...)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065142

Locations
France
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
GRSP : Groupement Régional de Santé Publique
URML : Union Régionale des Médecins Libéraux
Ministry of Health, France
URCAM : Union Régionale des Caisses d’Assurances Maladies
Sanofi
Groupe Pasteur Mutualité
Investigators
Principal Investigator: Hélène Vaillant-Roussel, MD University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01065142     History of Changes
Other Study ID Numbers: CHU-0067, 2009-A01142-55
Study First Received: February 8, 2010
Last Updated: March 27, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Heart Failure
Patient Education as Topic
Primary Health Care
Quality of Life

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014