An interventional study of Therapeutic education in Heart Failure and Quality of Life, sponsored by University Hospital, Clermont-Ferrand. Active, not recruiting at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other
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.
General organisation of the study
First consultation used to the inclusion:
Intervention of the general practitioner to the patients in the scope of a therapeutic education program:
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 200 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Improve therapeutic education efficiency on life quality of heart failure patients in general practice
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
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
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand