Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03035123 |
| Other study ID # |
EduStra-HF |
| Secondary ID |
RCB ID: 2016-A00 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2017 |
| Est. completion date |
September 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Resicard |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
