Heart FailureEduStra-HFNCT03035123
Therapeutic Education Strategy for Patients With Acute Heart Failure
A study testing Therapeutic education in people with Heart Failure, run by Resicard at 6 sites in France.
Trial summary
The EduStra-HF study will examine the impact of an intensive therapeutic education on patients discharged from hospital after an episode of acute heart failure (HF). Patients will be randomized into two groups: one will receive "usual care" monitoring and one will receive a specific educational monitoring programme… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Therapeutic education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Apr 2017to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient with acute HF
- Affiliated to the French Social Security system
- Accepting the principle of telephone monitoring
- Accepting home visits from a study nurse
- Possession of a mobile phone
Who cannot join
- Psychosocial:
- Refusal to accept the study design
- Patient under guardianship
- Monitoring obstacle: language, cognitive deficiency, itinerant lifestyle, regular travel, institutionalization
- Inability to sign the consent form or to complete questionnaires
- Medical:
Show all 15Show fewer
- Active cancer
- Severe psychiatric or neurological disorder
- Complicated acute myocardial infarction
- Significant valvular diseases requiring surgery
- Hypertrophic obstructive cardiomyopathy
- Planned heart transplant
- Cardiac surgery in the previous 3 months
- Enrollment in another clinical trial
- Medical or surgical procedure which might interfere with monitoring
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Clinique Ambroise Paré
Neuilly-sur-Seine, 92200
Clinique du Mont Louis
Paris, 75011
Hopital AP-HP Saint-Antoine
Paris, 75012
Institut Mutualiste Montsouris
Paris, 75014
Centre Cardiologique du Nord
Saint-Denis, 93200
Centre Hospitalier André Mignot
Versailles, 78000
About this study
Official title: Impact of an Intensive Therapeutic Education on Occurrence of Clinical Events in Patients With Acute Heart Failure: EduStra-HF Study
The EduStra-HF study will examine the impact of an intensive therapeutic education on patients discharged from hospital after an episode of acute heart failure (HF).
Patients will be randomized into two groups: one will receive "usual care" monitoring and one will receive a specific educational monitoring programme for 1 year.
All patients will meet with a specialized therapeutic education nurse before discharge.
The effect of the intensive education on HF rehospitalization and quality of life will be examined.
Read the detailed description
The prevalence of HF in France is increasing. According to a report from the Haute Autorité de Santé (HAS) - the French Health Authority - published in June 2015 concerning discharge of patients hospitalized for HF, 2.3% of the French adult population is affected. Despite improvements in treatment and HF-specific care, the rehospitalization rate for HF remains substantial, and HF management is a major public health issue.
Chronic HF leads to psychological and physiological issues in patients. Furthermore, this disease affects patient quality of life and activities of daily living.
The HAS also reported that even if iterative hospitalizations are the consequence of complicated and multifactorial situations, some could be prevented by improved patient care.
The aim of the EduStra-HF study is to examine the effect of an intensive therapeutic education on patients discharged from hospital after an episode of acute HF. It will study whether this intervention reduces the rate of rehospitalization and increases quality of life in this population.
To achieve this goal, a multicentre, randomized, two parallel arm study will be conducted. Patients will be included in several cardiology centres in Paris (Ile-de-France) over 2 years and 3 months.
Included patients, chosen from patients admitted for acute HF in the participating hospitals, will be randomized into two groups, which will determine the monitoring they receive after discharge. For each patient, monitoring will last for 1 year from the day they return home.
The first group of patients will be randomized to receive "usual care" monitoring and will not be given specific therapeutic education after discharge.
The second group (intervention arm) will receive a specific educational monitoring programme from nurses via telephone calls and home visits, for 1 year. Monitoring will began early after discharge. Annual medical monitoring and visits to the cardiologist will also be planned.
All patients, regardless of attribution arm, will meet a nurse trained in therapeutic education during their stay in hospital. Moreover, validated and HF-related self-assessed questionnaires will be analyzed to assess quality of life and impact of HF on patient activities of daily living.
In the interventional arm, patients will receive monitoring documents, such as a HF information booklet and a personal monitoring agenda.
The EduStra-HF study will provide a specific analysis of a multisupport therapeutic education (including medical monitoring). Data on all HF drug treatments, including the more recent ones (e.g. Entresto), blood tests results, and cardiologic data will be recorded.
- Conditions
- Heart Failure
- Being tested
- Therapeutic education
- Keywords
- Heart Failure, Therapeutic education, 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 educationBehavioural
Interventional arm
| Study group | Role | What they receive |
|---|---|---|
| "Usual care" | No intervention | Patients will attend an appointment with the therapeutic education nurse before discharge, after which they will have no further contact with the education team. The Research team members will telephone the patient three times during the year (after 2, 6 and 12 months) to collect data on HF treatments, blood tests results, health-related events and hospitalizations. |
| Interventional | Experimental | Before discharge, patients will attend an appointment with a nurse trained in therapeutic education, in which the nurse will evaluate the overall knowledge and the skills of the patient about HF. The nurse will then define specific educational objectives with the patient, based on the patient's medical history, state of disease, comorbidities, alarm signs, fears and knowledge.
Each patient will receive six telephone calls and two home-visits during the 1 year of follow-up. Each contact between the nurse and the patient will be dedicated to HF education. The patient will also receive regular short text messages containing health advice and appointment reminders.
To help the patient regain his/her autonomy, intervals between education sessions will be progressively longer. Receives: Behavioral: Therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of rehospitalizations for acute heart failure (HF) in both groups of patients
Measured: 1 year
Secondary outcomes (7)
Patients knowledge about the illness
Nurses will evaluate during each telephone call and home visit patients knowledge and skills about the following items : illness, treatments, diet, physical activity, medical follow-up. This data will be recorded in a specific table and classified into "acquired / partially acquired / not acquired" items.
Measured: 1 year
Global quality of life
Assessed by validated questionnaire SF-12
Measured: 1 year
Quality of life linked to Heart Failure
Assessed by validated questionnaire KCCQ-15
Measured: 1 year
Length of stay for HF and all-cause hospitalizations
Measured: 1 year of follow-up
Hospitalization rate for cardiovascular diseases except HF
Measured: 1 year of follow-up
Cardiovascular and all-cause mortality rate
Measured: 1 year of follow-up
B-type natriuretic peptide (BNP) or NT pro-BNP levels
Measured: During 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start1 Apr 2017
- Primary completion30 Dec 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resicard
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France, Assistance Publique - Hôpitaux de Paris, French Cardiology Society
- Responsible party
- Principal investigator, Pr Ariel Cohen, Saint Antoine University Hospital
- Investigators
- Ariel Cohen, MD PhD, Principal investigator, Hôpital Saint-Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035123
- Sponsor's protocol ID
- EduStra-HF
- Other IDs
- RCB ID: 2016-A00899-42
- Acronym
- EduStra-HF
- Status last verified
- Mar 2025
- First submitted
- 5 Dec 2016
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing Individual Participant Data requires a specific authorization from the French Board CNIL (Commission Nationale de l'Informatique et des Libertés) which chooses whether to allow the research team to share patient data. A specific request is needed and will be sent to that authority.
Publications
Jullien S, Lang S, Gerard M, Soulat-Dufour L, Brito E, Ocokoljic E, Laperche T, Georges JL, Diakov C, Belliard O, Larrazet F, Bataille S, Assyag P, Cohen A; EduStra-HF investigators. Intensive therapeutic education strategy for patients with acute heart failure (EduStra-HF): Design of a randomized controlled trial. Arch Cardiovasc Dis. 2024 Oct;117(10):561-568. doi: 10.1016/j.acvd.2024.04.006. Epub 2024 Jul 4.
PubMed 39089896
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Intensive Therapeutic Education on Occurrence of Clinical Events in Patients With Acute Heart Failure: EduStra-HF Study
- ClinicalTrials.gov ID
- NCT03035123
- Acronym / sponsor ID
- EduStra-HF / EduStra-HF
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Therapeutic education, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- ResicardUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France, Assistance Publique - Hôpitaux de Paris, French Cardiology Society
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Jan 2017 (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.
The EduStra-HF study will examine the impact of an intensive therapeutic education on patients discharged from hospital after an episode of acute heart failure (HF).
Patients will be randomized into two groups: one will receive "usual care" monitoring and one will receive a specific educational monitoring programme for 1 year.
All patients will meet with a specialized therapeutic education nurse before discharge.
The effect of the intensive education on HF rehospitalization and quality of life will be examined.
Detailed description
The prevalence of HF in France is increasing. According to a report from the Haute Autorité de Santé (HAS) - the French Health Authority - published in June 2015 concerning discharge of patients hospitalized for HF, 2.3% of the French adult population is affected. Despite improvements in treatment and HF-specific care, the rehospitalization rate for HF remains substantial, and HF management is a major public health issue.
Chronic HF leads to psychological and physiological issues in patients. Furthermore, this disease affects patient quality of life and activities of daily living.
The HAS also reported that even if iterative hospitalizations are the consequence of complicated and multifactorial situations, some could be prevented by improved patient care.
The aim of the EduStra-HF study is to examine the effect of an intensive therapeutic education on patients discharged from hospital after an episode of acute HF. It will study whether this intervention reduces the rate of rehospitalization and increases quality of life in this population.
To achieve this goal, a multicentre, randomized, two parallel arm study will be conducted. Patients will be included in several cardiology centres in Paris (Ile-de-France) over 2 years and 3 months.
Included patients, chosen from patients admitted for acute HF in the participating hospitals, will be randomized into two groups, which will determine the monitoring they receive after discharge. For each patient, monitoring will last for 1 year from the day they return home.
The first group of patients will be randomized to receive "usual care" monitoring and will not be given specific therapeutic education after discharge.
The second group (intervention arm) will receive a specific educational monitoring programme from nurses via telephone calls and home visits, for 1 year. Monitoring will began early after discharge. Annual medical monitoring and visits to the cardiologist will also be planned.
All patients, regardless of attribution arm, will meet a nurse trained in therapeutic education during their stay in hospital. Moreover, validated and HF-related self-assessed questionnaires will be analyzed to assess quality of life and impact of HF on patient activities of daily living.
In the interventional arm, patients will receive monitoring documents, such as a HF information booklet and a personal monitoring agenda.
The EduStra-HF study will provide a specific analysis of a multisupport therapeutic education (including medical monitoring). Data on all HF drug treatments, including the more recent ones (e.g. Entresto), blood tests results, and cardiologic data will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Usual care" | No intervention | –Patients will attend an appointment with the therapeutic education nurse before discharge, after which they will have no further contact with the education team. The Research team members will telephone the patient three times during the year (after 2, 6 and 12 months) to collect data on HF treatments, blood tests results, health-related events and hospitalizations. |
| Interventional | Experimental | Behavioral: Therapeutic educationBefore discharge, patients will attend an appointment with a nurse trained in therapeutic education, in which the nurse will evaluate the overall knowledge and the skills of the patient about HF. The nurse will then define specific educational objectives with the patient, based on the patient's medical history, state of disease, comorbidities, alarm signs, fears and knowledge. Each patient will receive six telephone calls and two home-visits during the 1 year of follow-up. Each contact between the nurse and the patient will be dedicated to HF education. The patient will also receive regular short text messages containing health advice and appointment reminders. To help the patient regain his/her autonomy, intervals between education sessions will be progressively longer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient with acute HF
- Affiliated to the French Social Security system
- Accepting the principle of telephone monitoring
- Accepting home visits from a study nurse
- Possession of a mobile phone
Key exclusion criteria (15 listed)
- Refusal to accept the study design
- Patient under guardianship
- Monitoring obstacle: language, cognitive deficiency, itinerant lifestyle, regular travel, institutionalization
- Inability to sign the consent form or to complete questionnaires
- Active cancer
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 educationInterventional arm | Behavioural | Interventional |
Primary outcome
Number of rehospitalizations for acute heart failure (HF) in both groups of patients
Time frame: 1 year
7 secondary outcomes
Patients knowledge about the illness
Time frame: 1 year
Global quality of life
Time frame: 1 year
Quality of life linked to Heart Failure
Time frame: 1 year
Length of stay for HF and all-cause hospitalizations
Time frame: 1 year of follow-up
Hospitalization rate for cardiovascular diseases except HF
Time frame: 1 year of follow-up
Cardiovascular and all-cause mortality rate
Time frame: 1 year of follow-up
B-type natriuretic peptide (BNP) or NT pro-BNP levels
Time frame: During 1 year of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 39089896Jullien S, Lang S, Gerard M, Soulat-Dufour L, Brito E, Ocokoljic E, Laperche T, Georges JL, Diakov C, Belliard O, Larrazet F, Bataille S, Assyag P, Cohen A; EduStra-HF investigators. Intensive therapeutic education strategy for patients with acute heart failure (EduStra-HF): Design of a randomized controlled trial. Arch Cardiovasc Dis. 2024 Oct;117(10):561-568. doi: 10.1016/j.acvd.2024.04.006. Epub 2024 Jul 4.
- Individual participant dataSharing planned: Undecided. Sharing Individual Participant Data requires a specific authorization from the French Board CNIL (Commission Nationale de l'Informatique et des Libertés) which chooses whether to allow the research team to share patient data. A specific request is needed and will be sent to that authority.
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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.
Ariel Cohen, MD PhD principal investigator
Hôpital Saint-Antoine
6 sites 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, run by Resicard at 6 sites 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of rehospitalizations for acute heart failure (HF) in both groups of patients (time frame: 1 year). 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 NCT03035123, which also lists 1 linked publication.
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 Apr 2025.