Heart FailureETICNCT01065142
ETIC (Therapeutic Education in Heart Failure)
A study testing Therapeutic education in people with Heart Failure and Quality of Life, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure, Quality of Life
- What is being tested?
- Therapeutic education
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- • 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...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Therapeutic Education Improve Heart Failure Patient Quality of Life?
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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure, Quality of Life
- Being tested
- Therapeutic education
- Keywords
- Heart Failure, Patient Education as Topic, Primary Health Care, Quality of Life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educationProcedure or surgery
Improve therapeutic education efficiency on life quality of heart failure patients in general practice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 0, 7, 13 and 19 months from the beginning of the incusion
Secondary outcomes (1)
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.
Measured: during the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startApr 2011
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Hélène Vaillant-Roussel, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065142
- Sponsor's protocol ID
- CHU-0067
- Other IDs
- 2009-A01142-55
- Acronym
- ETIC
- Status last verified
- Jul 2026
- First submitted
- 8 Feb 2010
- Last updated
- 3 Aug 2026
- Results posted
- No
Publications
Vaillant-Roussel H, Laporte C, Pereira B, De Rosa M, Eschalier B, Vorilhon C, Eschalier R, Clement G, Pouchain D, Chenot JF, Dubray C, Vorilhon P. Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial. BMC Fam Pract. 2016 Jul 19;17:80. doi: 10.1186/s12875-016-0473-4.
PubMed 27436289Vaillant-Roussel H, Laporte C, Pereira B, Tanguy G, Cassagnes J, Ruivard M, Clement G, Le Reste JY, Lebeau JP, Chenot JF, Pouchain D, Dubray C, Vorilhon P. Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial. BMC Fam Pract. 2014 Dec 24;15:208. doi: 10.1186/s12875-014-0208-3.
PubMed 25539989
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Therapeutic Education Improve Heart Failure Patient Quality of Life?
- ClinicalTrials.gov ID
- NCT01065142
- Acronym / sponsor ID
- ETIC / CHU-0067
- Conditions
- Heart Failure, Quality of Life
- Keywords
- Heart Failure, Patient Education as Topic, Primary Health Care, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- 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
- Study start
- Apr 2011
- Primary completion
- Jul 2014 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic educationImprove therapeutic education efficiency on life quality of heart failure patients in general practice | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 27436289Vaillant-Roussel H, Laporte C, Pereira B, De Rosa M, Eschalier B, Vorilhon C, Eschalier R, Clement G, Pouchain D, Chenot JF, Dubray C, Vorilhon P. Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial. BMC Fam Pract. 2016 Jul 19;17:80. doi: 10.1186/s12875-016-0473-4.
- Derived from this study: PubMed 25539989Vaillant-Roussel H, Laporte C, Pereira B, Tanguy G, Cassagnes J, Ruivard M, Clement G, Le Reste JY, Lebeau JP, Chenot JF, Pouchain D, Dubray C, Vorilhon P. Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial. BMC Fam Pract. 2014 Dec 24;15:208. doi: 10.1186/s12875-014-0208-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Vaillant-Roussel, MD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic education in people with Heart Failure and Quality of Life, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01065142, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.