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Therapeutic Education Strategy for Patients With Acute Heart Failure

Impact of an Intensive Therapeutic Education on Occurrence of Clinical Events in Patients With Acute Heart Failure: EduStra-HF Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03035123
Acronym
EduStra-HF
Enrollment
318
Registered
2017-01-27
Start date
2017-04-01
Completion date
2024-12-30
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Therapeutic education, Quality of life

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.

Interventions

BEHAVIORALTherapeutic education

Interventional arm

Sponsors

Agence Regionale de Sante d'Ile de France
CollaboratorOTHER_GOV
Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
French Cardiology Society
CollaboratorOTHER
Resicard
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of rehospitalizations for acute heart failure (HF) in both groups of patients1 year

Secondary

MeasureTime frameDescription
Patients knowledge about the illness1 yearNurses 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.
Global quality of life1 yearAssessed by validated questionnaire SF-12
Quality of life linked to Heart Failure1 yearAssessed by validated questionnaire KCCQ-15
Hospitalization rate for cardiovascular diseases except HF1 year of follow-up
Cardiovascular and all-cause mortality rate1 year of follow-up
B-type natriuretic peptide (BNP) or NT pro-BNP levelsDuring 1 year of follow-up
Length of stay for HF and all-cause hospitalizations1 year of follow-up

Other

MeasureTime frameDescription
Cost effectiveness of the interventionDuring 1 year of follow-upComparison between both groups of patients of the HF-hospitalizations average cost, related to the operating cost of the EduStra-HF method.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026