Active — Not RecruitingNot Applicable

ETIC (Therapeutic Education in Heart Failure)

France200 participantsStarted 2011-04

Plain-language 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 an…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT01065142

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-07

View on ClinicalTrials.gov More Heart Failure trials