Therapeutic Education Strategy for Patients With Acute Heart Failure
EduStra-HF
Impact of an Intensive Therapeutic Education on Occurrence of Clinical Events in Patients With Acute Heart Failure: EduStra-HF Study
2 other identifiers
interventional
318
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Apr 2017
Longer than P75 for not_applicable heart-failure
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedApril 3, 2025
March 1, 2025
6.8 years
December 5, 2016
March 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of rehospitalizations for acute heart failure (HF) in both groups of patients
1 year
Secondary Outcomes (7)
Patients knowledge about the illness
1 year
Global quality of life
1 year
Quality of life linked to Heart Failure
1 year
Length of stay for HF and all-cause hospitalizations
1 year of follow-up
Hospitalization rate for cardiovascular diseases except HF
1 year of follow-up
- +2 more secondary outcomes
Other Outcomes (1)
Cost effectiveness of the intervention
During 1 year of follow-up
Study Arms (2)
"Usual care"
NO INTERVENTIONPatients will attend an appointment with the therapeutic education nurse before discharge, after which they will have no further contact with the education team. The Research team members will telephone the patient three times during the year (after 2, 6 and 12 months) to collect data on HF treatments, blood tests results, health-related events and hospitalizations.
Interventional
EXPERIMENTALBefore discharge, patients will attend an appointment with a nurse trained in therapeutic education, in which the nurse will evaluate the overall knowledge and the skills of the patient about HF. The nurse will then define specific educational objectives with the patient, based on the patient's medical history, state of disease, comorbidities, alarm signs, fears and knowledge. Each patient will receive six telephone calls and two home-visits during the 1 year of follow-up. Each contact between the nurse and the patient will be dedicated to HF education. The patient will also receive regular short text messages containing health advice and appointment reminders. To help the patient regain his/her autonomy, intervals between education sessions will be progressively longer.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Resicardlead
- Agence Regionale de Sante d'Ile de Francecollaborator
- Assistance Publique - Hôpitaux de Pariscollaborator
- French Cardiology Societycollaborator
Study Sites (6)
Clinique Ambroise Paré
Neuilly-sur-Seine, 92200, France
Clinique du Mont Louis
Paris, 75011, France
Hopital AP-HP Saint-Antoine
Paris, 75012, France
Institut Mutualiste Montsouris
Paris, 75014, France
Centre Cardiologique du Nord
Saint-Denis, 93200, France
Centre Hospitalier André Mignot
Versailles, 78000, France
Related Publications (1)
Jullien S, Lang S, Gerard M, Soulat-Dufour L, Brito E, Ocokoljic E, Laperche T, Georges JL, Diakov C, Belliard O, Larrazet F, Bataille S, Assyag P, Cohen A; EduStra-HF investigators. Intensive therapeutic education strategy for patients with acute heart failure (EduStra-HF): Design of a randomized controlled trial. Arch Cardiovasc Dis. 2024 Oct;117(10):561-568. doi: 10.1016/j.acvd.2024.04.006. Epub 2024 Jul 4.
PMID: 39089896DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ariel Cohen, MD PhD
Hôpital Saint-Antoine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the cardiology department
Study Record Dates
First Submitted
December 5, 2016
First Posted
January 27, 2017
Study Start
April 1, 2017
Primary Completion
December 30, 2023
Study Completion
December 30, 2024
Last Updated
April 3, 2025
Record last verified: 2025-03