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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor) (EDUSOR)

10 luglio 2026 aggiornato da: University Hospital, Clermont-Ferrand

Evaluation of a Therapeutic Patient Education Program for Discharge (ETPsh) by Nurses in a French Hospital Setting Among Patients With Heart Failure

Heart failure affects 2.3% of the adult French population. Readmission within 30 days doubles the risk of early death within the following 30 to 60 days, as well as the risk of rehospitalization over the subsequent two years. Incorporating nurse-led discharge education can significantly reduce readmissions for heart failure as well as all-cause readmissions. Drawing on practices from English-speaking countries and Switzerland regarding patient discharge education at hospital, we propose to evaluate a discharge education program in the French hospital setting for patients with heart failure.

The objective of this multicenter before-and-after study is to evaluate the impact of a nurse-led discharge education delivered at hospital on the quality of the care pathway for patients with heart failure, assessed 30 days after hospital discharge. The primary outcome is the reduction in 30-day unplanned all-cause hospital readmissions, including emergency department visits. An informal (non-professional) caregiver may also be enrolled in the study if identified by the patient and present during the hospitalization.

Patients enrolled before implementation of the discharge education will constitute the control group (standard therapeutic patient education group). They will receive usual hospital care, including educational sessions throughout hospitalization covering the disease, treatments, and self-care, as well as a follow-up consultation with a nurse 30 days after hospital discharge. This usual care is referred to as standard therapeutic patient education and does not include a structured therapeutic patient education intervention at hospital discharge.

Patients receiving the discharge education will constitute the intervention group (standard therapeutic patient education with discharge education group). They will receive the same usual care (i.e., standard therapeutic patient education and the 30-day post-discharge nurse follow-up consultation), supplemented by the nurse-led discharge education intervention during their hospitalization.

To minimize the risk of contamination (diffusion bias), the control group will be enrolled and complete follow-up before nurses receive training in the discharge education intervention.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Patients and their informal caregivers will be informed about the study by the nursing staff within the first two days of hospitalization in the cardiology departments participating in the study. Their eligibility will then be assessed, and eligible patients and caregivers will be invited to participate. A participant information sheet describing the study will be provided and explained to both the patient and the informal caregiver.

Patients and their informal caregivers will be given a 24-hour reflection period. After this period, they will have the opportunity to discuss any remaining questions with the investigator nurse, who will provide any necessary clarification. Patients and informal caregivers who agree to participate will then sign the informed consent form and be enrolled in the study. The investigator will also sign the informed consent form.

All participants in the control group will be enrolled simultaneously across the three participating study centers. The same enrollment procedure will be followed for the intervention group.

Patients in the intervention group will receive an initial educational assessment on the day following enrollment, a participatory therapeutic education session using the teach-back method within the 24 hours preceding hospital discharge, a follow-up telephone call from a nurse 7 days after discharge, and a final educational assessment at the routine 30-day post-discharge follow-up visit. Whenever possible, the patient's informal caregiver will be asked to accompany the patient to this follow-up consultation.

A participant may be prematurely withdrawn from the study for any of the following reasons:

  • an intercurrent disease interfering with the normal conduct of the study protocol;
  • death;
  • participant's decision
  • a major protocol deviation;
  • loss to follow-up (a participant is considered lost to follow-up if they fail to attend a scheduled study visit and no information regarding their status can be obtained despite all reasonable efforts to contact them and determine the reason for study discontinuation. The reason "lost to follow-up" will only be assigned after these efforts have been unsuccessful).

Patients and their informal caregivers may participate in another clinical study provided that, in the opinion of the investigator, such participation does not interfere with the conduct or objectives of the present study. Participants must therefore inform the investigator of any concurrent participation in another study, and the investigator will determine whether simultaneous participation is appropriate.

The study may be temporarily suspended or permanently terminated for any of the following reasons:

  • insufficient or no participant recruitment;
  • inability to secure funding for the study;
  • any directive issued by the competent regulatory authorities requiring the temporary suspension or permanent termination of the study;
  • a decision by the sponsor and the coordinating investigator.

Tipo di studio

Interventistico

Iscrizione (Stimato)

412

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Francia
      • Clermont-Ferrand, Francia
        • CHU clermont-ferrand
        • Contatto:
        • Investigatore principale:
          • Sarah LAROCHE
      • Poitiers, Francia
      • Vichy, Francia
        • CH VICHY
        • Contatto:
        • Investigatore principale:
          • Claude LAGRANGE

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patient aged 18 years old or more,
  • Fluent in spoken and written French,
  • Willing to participate in the study,
  • Hospitalized for heart failure in one of the participating centers for at least 2 days,
  • Affiliated with a French social security scheme
  • Discharged either to home or transferred to a Medical and Rehabilitation Care unit.

Exclusion Criteria:

  • Hospitalized for a reason other than heart failure,
  • Previously included in the study during a prior hospitalization,
  • Presenting with identified cognitive impairment,
  • In a situation deemed inappropriate by the care team (end of life),
  • Living in an institutional setting,
  • Pregnant women,
  • Breastfeeding women,
  • Under legal protective measures,
  • Enrolled in another interventional research study that may interfere with the results of the present study, according to the investigator's judgment.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Standard therapeutic patient education group

Participants in the control group will receive usual care in the cardiology department.

The multidisciplinary usual care involves both medical professionals (including cardiologists and pharmacists) and allied health professionals (including advanced practice nurses, registered nurses, dietitians, and physical activity specialists). Usual care is integrated into the heart failure care pathway, ensuring continuity between community-based and hospital care, hospitalization, and ongoing management at home.

During hospitalization, participants will receive standard therapeutic patient education as well as a routine nurse-led follow-up consultation 30 days after hospital discharge. Patients will also receive the standard discharge documents, together with the usual information and advice provided at discharge.
Sperimentale: Discharge education group
Participants will receive usual care (as described for the control group), supplemented by a structured discharge education intervention delivered by research nurses trained in therapeutic patient education.
Comportamentale: Nurse-led discharge education

The intervention includes :

  1. An initial educational assessment (≈1 h) on the day after enrollment to identify individualized learning needs for discharge and assess key self-management and safety competencies ;
  2. An interactive discharge education session (≈1 h) within 24 hours before discharge, using the teach-back method to reinforce warning signs, medication, self-care, follow-up, and healthcare contacts ;
  3. A nurse-led follow-up telephone call 7 (±3) days after discharge (15-30 min) to assess competencies and reinforce learning if needed ;
  4. A final educational assessment (≈1 h) during the routine 30-day (±7 days) follow-up consultation. Informal caregivers will be invited to participate whenever possible.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Unplanned all-cause rehospitalizations, including emergency department visits.
Lasso di tempo: At 30 days after hospital discharge
Rehospitalization is defined as "an unplanned hospital stay of at least one overnight stay"
At 30 days after hospital discharge

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Unplanned rehospitalizations, including emergency department visits, for heart failure.
Lasso di tempo: At 30 days after hospital discharge
Rehospitalizations are assessed using the European Society of Cardiology definition of hospitalization for heart failure. Those that meet the criteria of this definition are classified as heart failure-related readmissions.
At 30 days after hospital discharge
Patient death
Lasso di tempo: At 30 days after hospital discharge
At 30 days after hospital discharge
Patient satisfaction of the hospital discharge organization
Lasso di tempo: At 30 days after hospital discharge
Score on the "Hospital Discharge Organization" dimension of the French National Authority for Health "e-Satis+48h MCO" questionnaire, a national patient satisfaction and experience self-administrated questionnaire for hospitalized patients
At 30 days after hospital discharge
Scheduled rehospitalizations that were not completed.
Lasso di tempo: At 30 days after hospital discharge
At 30 days after hospital discharge
Number of consultations with the patient's primary care physician.
Lasso di tempo: At 30 days after hospital discharge
At 30 days after hospital discharge
Scheduling of a cardiology consultation (appointment made).
Lasso di tempo: At 30 days after hospital discharge
At 30 days after hospital discharge
Daily adherence to cardiovascular medication
Lasso di tempo: At baseline
Measurement of cardiovascular medication adherence using the self-administered MASCARD questionnaire
At baseline
Daily adherence to cardiovascular medication
Lasso di tempo: At 30 days after hospital discharge
Measurement of cardiovascular medication adherence using the self-administered MASCARD questionnaire
At 30 days after hospital discharge
Number of warning signs and self-care behaviors cited by the patient.
Lasso di tempo: At 30 days after hospital discharge
Warning signs : Shortness of breath - Rapid weight gain - Lower limb edema - Fatigue Sel-care behaviors: Physical activity - Weighing oneself - Medication adherence - Avoiding added salt
At 30 days after hospital discharge
Heart failure self-care behaviors
Lasso di tempo: At baseline
Assessed using the European Heart Failure Self-Care Behaviour Scale-9 (EHFScB-9) self-administered questionnaire
At baseline
Heart failure self-care behaviors
Lasso di tempo: At 30 days after hospital discharge
Assessed using the European Heart Failure Self-Care Behaviour Scale-9 (EHFScB-9) self-administered questionnaire
At 30 days after hospital discharge
Completeness rate of remote monitoring data transmission for patients enrolled in telemonitoring
Lasso di tempo: At 30 days after hospital discharge
Weight, blood pressure, oxygen saturation
At 30 days after hospital discharge
Number of alerts and number of medically managed alerts, generated through remote monitoring for patients enrolled in telemonitoring
Lasso di tempo: At 30 days after hospital discharge
At 30 days after hospital discharge
Self-perceived patient competence in disease management
Lasso di tempo: At baseline
Assessed using a 0-5 "skills star" scale (management of medications, management of follow-up appointments, recognition of warning signs, and implementation of self-care behaviors).
At baseline
Self-perceived patient competence in disease management
Lasso di tempo: At 30 days after hospital discharge
Assessed using a 0-5 "skills star" scale (management of medications, management of follow-up appointments, recognition of warning signs, and implementation of self-care behaviors).
At 30 days after hospital discharge
Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway
Lasso di tempo: At baseline
Assessed using a 0-5 "skills star" scale (communication with healthcare professionals).
At baseline
Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway
Lasso di tempo: At 30 days after hospital discharge
Assessed using a 0-5 "skills star" scale (communication with healthcare professionals).
At 30 days after hospital discharge
Anxiety and depression of patients
Lasso di tempo: At baseline
Assessed using the self-administrated Hospital Anxiety and Depression Scale (HADS).
At baseline
Anxiety and depression of patients
Lasso di tempo: At 30 days after hospital discharge
Assessed using the self-administrated Hospital Anxiety and Depression Scale (HADS).
At 30 days after hospital discharge
Informal caregiver burden
Lasso di tempo: At baseline
Assessed using the Mini-Zarit self-administered questionnaire.
At baseline
Informal caregiver burden
Lasso di tempo: At 30 days after hospital discharge
Assessed using the Mini-Zarit self-administered questionnaire.
At 30 days after hospital discharge
Cost-effectiveness and budget impact medico-economic analysis of discharge education.
Lasso di tempo: At 30 days after hospital discharge
Incremental cost-effectiveness ratio of discharge education and the bundled payment amount compatible with the financial sustainability of discharge education.
At 30 days after hospital discharge

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Clermont-Ferrand

Investigatori

  • Investigatore principale: Marie Sophie CHERILLAT, University Hospital, Clermont-Ferrand

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 aprile 2028

Completamento dello studio (Stimato)

1 aprile 2028

Date di iscrizione allo studio

Primo inviato

10 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 luglio 2026

Primo Inserito (Effettivo)

15 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 luglio 2026

Ultimo verificato

1 marzo 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PHRIP 2024 CHERILLAT
  • 2025-A02457-42 (Altro identificatore: ANSM)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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