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

Heart Failure Clinical Trial

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

Status Active, not recruiting

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT03035123
• Study type: Interventional
• Source: Resicard
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2017
• Completion date: September 30, 2024