An interventional study of Nurse-led discharge education in Heart Failure, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Supportive care
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.
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:
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:
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 412 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Behavioral: 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.
Unplanned all-cause rehospitalizations, including emergency department visits.
Rehospitalization is defined as "an unplanned hospital stay of at least one overnight stay"
Time frame: At 30 days after hospital discharge
Unplanned rehospitalizations, including emergency department visits, for heart failure.
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.
Time frame: At 30 days after hospital discharge
Patient death
Time frame: At 30 days after hospital discharge
Patient satisfaction of the hospital discharge organization
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
Time frame: At 30 days after hospital discharge
Scheduled rehospitalizations that were not completed.
Time frame: At 30 days after hospital discharge
Number of consultations with the patient's primary care physician.
Time frame: At 30 days after hospital discharge
Scheduling of a cardiology consultation (appointment made).
Time frame: At 30 days after hospital discharge
Daily adherence to cardiovascular medication
Measurement of cardiovascular medication adherence using the self-administered MASCARD questionnaire
Time frame: At baseline
Daily adherence to cardiovascular medication
Measurement of cardiovascular medication adherence using the self-administered MASCARD questionnaire
Time frame: At 30 days after hospital discharge
Number of warning signs and self-care behaviors cited by the patient.
Warning signs : Shortness of breath - Rapid weight gain - Lower limb edema - Fatigue Sel-care behaviors: Physical activity - Weighing oneself - Medication adherence - Avoiding added salt
Time frame: At 30 days after hospital discharge
Heart failure self-care behaviors
Assessed using the European Heart Failure Self-Care Behaviour Scale-9 (EHFScB-9) self-administered questionnaire
Time frame: At baseline
Heart failure self-care behaviors
Assessed using the European Heart Failure Self-Care Behaviour Scale-9 (EHFScB-9) self-administered questionnaire
Time frame: At 30 days after hospital discharge
Completeness rate of remote monitoring data transmission for patients enrolled in telemonitoring
Weight, blood pressure, oxygen saturation
Time frame: At 30 days after hospital discharge
Number of alerts and number of medically managed alerts, generated through remote monitoring for patients enrolled in telemonitoring
Time frame: At 30 days after hospital discharge
Self-perceived patient competence in disease management
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).
Time frame: At baseline
Self-perceived patient competence in disease management
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).
Time frame: At 30 days after hospital discharge
Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway
Assessed using a 0-5 "skills star" scale (communication with healthcare professionals).
Time frame: At baseline
Self-perceived patient competence in contacting and alerting the care team when experiencing difficulties in their care pathway
Assessed using a 0-5 "skills star" scale (communication with healthcare professionals).
Time frame: At 30 days after hospital discharge
Anxiety and depression of patients
Assessed using the self-administrated Hospital Anxiety and Depression Scale (HADS).
Time frame: At baseline
Anxiety and depression of patients
Assessed using the self-administrated Hospital Anxiety and Depression Scale (HADS).
Time frame: At 30 days after hospital discharge
Informal caregiver burden
Assessed using the Mini-Zarit self-administered questionnaire.
Time frame: At baseline
Informal caregiver burden
Assessed using the Mini-Zarit self-administered questionnaire.
Time frame: At 30 days after hospital discharge
Cost-effectiveness and budget impact medico-economic analysis of discharge education.
Incremental cost-effectiveness ratio of discharge education and the bundled payment amount compatible with the financial sustainability of discharge education.
Time frame: At 30 days after hospital discharge
Plan to share: No
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University Hospital, Clermont-Ferrand