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Could teaching heart failure patients to self-manage boost their quality of life?

NCT ID NCT01065142

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

200 people

The number who actually took part.

Start date

Apr 2011

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003, France

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