Clinical trial NCT03035123: Therapeutic Education Strategy for Patients With Acute Heart Failure
Official title: Impact of an Intensive Therapeutic Education on Occurrence of Clinical Events in Patients With Acute Heart Failure: EduStra-HF Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Therapeutic education
Quality of life
Lead sponsor: Resicard
Sponsor class: OTHER
Collaborators: name: Agence Regionale de Sante d'Ile de France
name: Assistance Publique - Hôpitaux de Paris
name: French Cardiology Society
First posted: 2017-01-27
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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:

* 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

Primary outcomes:
measure: Number of rehospitalizations for acute heart failure (HF) in both groups of patients
timeFrame: 1 year
Secondary outcomes:
measure: Patients knowledge about the illness
timeFrame: 1 year
measure: Global quality of life
timeFrame: 1 year
measure: Quality of life linked to Heart Failure
timeFrame: 1 year
measure: Length of stay for HF and all-cause hospitalizations
timeFrame: 1 year of follow-up
measure: Hospitalization rate for cardiovascular diseases except HF
timeFrame: 1 year of follow-up
measure: Cardiovascular and all-cause mortality rate
timeFrame: 1 year of follow-up
measure: B-type natriuretic peptide (BNP) or NT pro-BNP levels
timeFrame: During 1 year of follow-up
Other outcomes:
measure: Cost effectiveness of the intervention
timeFrame: During 1 year of follow-up
Locations:
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Paré
city: Paris
country: France
facility: Clinique du Mont Louis
city: Paris
country: France
facility: Hopital AP-HP Saint-Antoine
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
city: Versailles
country: France
facility: Centre Hospitalier André Mignot
Study officials:
affiliation: Hôpital Saint-Antoine
name: Ariel Cohen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: