Could teaching heart failure patients to self-manage boost their quality of life?
NCT ID NCT01065142
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial tests whether a structured therapeutic education program, delivered by general practitioners, can improve quality of life for people with heart failure. Around 200 patients in primary care will be randomly assigned to receive the program or usual care, and their quality of life and hospitalizations will be tracked over 19 months. The goal is to help patients recognize early signs of worsening and manage their condition better, potentially reducing hospital stays and improving daily well-being.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Therapeutic education program
- What this could lead to
- If effective, this program could help heart failure patients better manage their condition, spot warning signs early, and improve their daily quality of life.
- What could go wrong
- The trial is relatively small and relies on GP training, so results may vary. It may not show a clear benefit or may be hard to apply broadly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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200 people
The number who actually took part.
- Start date
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Apr 2011
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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...)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chu Clermont-Ferrand
Clermont-Ferrand, 63003, France
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