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

3 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

412

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • France
      • Clermont-Ferrand, France
        • Recrutement
        • CHU Clermont-Ferrand
        • Contact:
        • Chercheur principal:
          • Sarah LAROCHE
      • Poitiers, France
        • Pas encore de recrutement
        • CHU Poitiers
        • Contact:
        • Chercheur principal:
          • Alexandra MARTIN
      • Vichy, France
        • Pas encore de recrutement
        • CH Vichy
        • Contact:
        • Chercheur principal:
          • Claude LAGRANGE

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: 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.
Expérimental: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Unplanned all-cause rehospitalizations, including emergency department visits.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient death
Délai: At 30 days after hospital discharge
At 30 days after hospital discharge
Number of consultations with the patient's primary care physician.
Délai: At 30 days after hospital discharge
At 30 days after hospital discharge
Number of alerts and number of medically managed alerts, generated through remote monitoring for patients enrolled in telemonitoring
Délai: At 30 days after hospital discharge
At 30 days after hospital discharge
Unplanned rehospitalizations, including emergency department visits, for heart failure.
Délai: 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 satisfaction of the hospital discharge organization
Délai: At 30 days after hospital discharge

Assessed using the score for the "Discharge Organization" subscale of the French National Authority for Health (HAS) "e-Satis+48h MCO" self-administered questionnaire, which evaluates the experience of patients hospitalized for more than 48 hours in medicine, surgery, or obstetrics.

The "Discharge Organization" subscale consists of 10 items, from which a score ranging from 0 to 100 is calculated, with 0 indicating the poorest experience and 100 indicating the best possible experience.
At 30 days after hospital discharge
Number of scheduled readmissions not carried out.
Délai: At 30 days after hospital discharge
At 30 days after hospital discharge
Number of scheduled consultations with a cardiologist (including appointments made)
Délai: At 30 days after hospital discharge
At 30 days after hospital discharge
Daily adherence to cardiovascular medication
Délai: At baseline

Assessed using the score from the MASCARD self-administered questionnaire. This questionnaire consists of 5 items, from which a score ranging from 0 to 5 is calculated, with 0 indicating major difficulties with medication adherence and 5 indicating few or no difficulties with medication adherence.
At baseline
Daily adherence to cardiovascular medication
Délai: At 30 days after hospital discharge

Assessed using the score from the MASCARD self-administered questionnaire. This questionnaire consists of 5 items, from which a score ranging from 0 to 5 is calculated, with 0 indicating major difficulties with medication adherence and 5 indicating few or no difficulties with medication adherence.
At 30 days after hospital discharge
Number of warning signs and self-care behaviors cited by the patient.
Délai: 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
Délai: At baseline

Assessed using the score from the self-administered European Heart Failure Self-Care Behaviour Scale-9 (EHFScBS-9) questionnaire. This questionnaire consists of 9 items, from which a score ranging from 9 to 45 is calculated, with higher scores indicating poorer self-care behaviours.
At baseline
Heart failure self-care behaviors
Délai: At 30 days after hospital discharge

Assessed using the score from the self-administered European Heart Failure Self-Care Behaviour Scale-9 (EHFScBS-9) questionnaire. This questionnaire consists of 9 items, from which a score ranging from 9 to 45 is calculated, with higher scores indicating poorer self-care behaviours.
At 30 days after hospital discharge
Completeness rate of remote monitoring data transmission for patients enrolled in telemonitoring
Délai: At 30 days after hospital discharge

Body weight measured in kilograms (kg) Blood pressure measured in millimetres of mercury (mmHg) Oxygen saturation measured as a percentage (%)
At 30 days after hospital discharge
Self-perceived patient competence in disease management
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: At baseline

Assessed using scores from the Hospital Anxiety and Depression Scale (HADS) self-administered questionnaire, which consists of 14 items divided into 7-item "HADS Anxiety" and "HADS Depression" subscales. The total score for each subscale ranges from 0 to 21, with higher scores indicating a higher frequency of anxiety or depression symptoms.
At baseline
Anxiety and depression of patients
Délai: At 30 days after hospital discharge

Assessed using scores from the Hospital Anxiety and Depression Scale (HADS) self-administered questionnaire, which consists of 14 items divided into 7-item "HADS Anxiety" and "HADS Depression" subscales. The total score for each subscale ranges from 0 to 21, with higher scores indicating a higher frequency of anxiety or depression symptoms.
At 30 days after hospital discharge
Informal caregiver burden
Délai: At baseline

Assessed using the score from the Mini-Zarit Burden Interview. This self-administered questionnaire consists of 7 items, yielding a score ranging from 0 to 7, with 0 indicating absent or mild caregiver burden and 7 indicating severe caregiver burden.
At baseline
Informal caregiver burden
Délai: At 30 days after hospital discharge

Assessed using the score from the Mini-Zarit Burden Interview. This self-administered questionnaire consists of 7 items, yielding a score ranging from 0 to 7, with 0 indicating absent or mild caregiver burden and 7 indicating severe caregiver burden.
At 30 days after hospital discharge
Cost of training nurses in discharge education
Délai: At 30 days after hospital discharge

Cost of training nurses in discharge education (euros) to allow the economic analysis
At 30 days after hospital discharge
Cost of delivering the discharge education (euros) to allow the economic analysis
Délai: At 30 days after hospital discharge

Cost of delivering the discharge education, calculated as the duration of the discharge education multiplied by the fully loaded hourly cost of a nurse's salary.
At 30 days after hospital discharge
Cost of the telephone follow-up call(s) 7 days after hospital discharge (euros)
Délai: At 30 days after hospital discharge

Cost of the telephone follow-up call(s) 7 days after hospital discharge, calculated as the duration of the discharge education multiplied by the nurse's fully loaded hourly salary cost.
At 30 days after hospital discharge

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Clermont-Ferrand

Les enquêteurs

  • Chercheur principal: Marie Sophie CHERILLAT, University Hospital, Clermont-Ferrand

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 octobre 2026

Achèvement primaire (Estimé)

1 avril 2028

Achèvement de l'étude (Estimé)

1 avril 2028

Dates d'inscription aux études

Première soumission

10 juillet 2026

Première soumission répondant aux critères de contrôle qualité

10 juillet 2026

Première publication (Réel)

15 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PHRIP 2024 CHERILLAT
  • 2025-A02457-42 (Autre identifiant: ANSM)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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