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

November 3, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Recruiting
        • CHU Clermont-Ferrand
        • Contact:
        • Principal Investigator:
          • Sarah LAROCHE
      • Poitiers, France
        • Not yet recruiting
        • CHU Poitiers
        • Contact:
        • Principal Investigator:
          • Alexandra MARTIN
      • Vichy, France
        • Not yet recruiting
        • CH Vichy
        • Contact:
        • Principal Investigator:
          • Claude LAGRANGE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Unplanned all-cause rehospitalizations, including emergency department visits.
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient death
Time Frame: At 30 days after hospital discharge
At 30 days after hospital discharge
Number of consultations with the patient's primary care physician.
Time Frame: 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
Time Frame: At 30 days after hospital discharge
At 30 days after hospital discharge
Unplanned rehospitalizations, including emergency department visits, for heart failure.
Time Frame: 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
Time Frame: 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.
Time Frame: At 30 days after hospital discharge
At 30 days after hospital discharge
Number of scheduled consultations with a cardiologist (including appointments made)
Time Frame: At 30 days after hospital discharge
At 30 days after hospital discharge
Daily adherence to cardiovascular medication
Time Frame: 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
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie Sophie CHERILLAT, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHRIP 2024 CHERILLAT
  • 2025-A02457-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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