Therapeutic Education Strategy for Patients With Acute Heart Failure (EduStra-HF)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    1086
  • sponsor
    Resicard
Updated on 13 May 2022
heart failure
acute heart failure

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.

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.

Details
Condition Heart Failure
Treatment Therapeutic education
Clinical Study IdentifierNCT03035123
SponsorResicard
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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