Heart FailureEDUSORNCT07706543
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
A study testing Nurse-led discharge education in people with Heart Failure, run by University Hospital, Clermont-Ferrand at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Nurse-led discharge education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Oct 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Sarah LAROCHE, +33473754320, slaroche@chu-clermontferrand.fr
Sarah LAROCHE
- Not yet recruiting
CHU Poitiers
Poitiers
Alexandra MARTIN, +33549444418, alexandra.martin@chu-poitiers.fr
Alexandra MARTIN
- Not yet recruiting
CH Vichy
Vichy
Claude LAGRANGE, +33470310762, claude.lagrange@ch-vichy.fr
Claude LAGRANGE
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Nurse-led discharge education
- Keywords
- Heart failure, Discharge education, Nurses, Therapeutic education as topic, Readmission
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led discharge educationBehavioural
The intervention includes :
- 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 ;
- 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 ;
- A nurse-led follow-up telephone call 7 (±3) days after discharge (15-30 min) to assess competencies and reinforce learning if needed ;
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard therapeutic patient education group | No intervention | 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. |
| Discharge education group | Experimental | 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. Receives: Behavioral: Nurse-led discharge education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned all-cause rehospitalizations, including emergency department visits.
Rehospitalization is defined as "an unplanned hospital stay of at least one overnight stay"
Measured: At 30 days after hospital discharge
Secondary outcomes (24)
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.
Measured: At 30 days after hospital discharge
Patient death
Measured: At 30 days after hospital discharge
Patient satisfaction of the hospital discharge organization
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.
Measured: At 30 days after hospital discharge
Number of scheduled readmissions not carried out.
Measured: At 30 days after hospital discharge
Number of consultations with the patient's primary care physician.
Measured: At 30 days after hospital discharge
Number of scheduled consultations with a cardiologist (including appointments made)
Measured: At 30 days after hospital discharge
Daily adherence to cardiovascular medication
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.
Measured: At baseline
Daily adherence to cardiovascular medication
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.
Measured: 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
Measured: At 30 days after hospital discharge
Heart failure self-care behaviors
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.
Measured: At baseline
Heart failure self-care behaviors
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.
Measured: At 30 days after hospital discharge
Completeness rate of remote monitoring data transmission for patients enrolled in telemonitoring
Body weight measured in kilograms (kg) Blood pressure measured in millimetres of mercury (mmHg) Oxygen saturation measured as a percentage (%)
Measured: At 30 days after hospital discharge
Number of alerts and number of medically managed alerts, generated through remote monitoring for patients enrolled in telemonitoring
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At 30 days after hospital discharge
Anxiety and depression of patients
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.
Measured: At baseline
Anxiety and depression of patients
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.
Measured: At 30 days after hospital discharge
Informal caregiver burden
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.
Measured: At baseline
Informal caregiver burden
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.
Measured: At 30 days after hospital discharge
Cost of training nurses in discharge education
Cost of training nurses in discharge education (euros) to allow the economic analysis
Measured: At 30 days after hospital discharge
Cost of delivering the discharge education (euros) to allow the economic analysis
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.
Measured: At 30 days after hospital discharge
Cost of the telephone follow-up call(s) 7 days after hospital discharge (euros)
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.
Measured: At 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start29 Oct 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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. Participants in the control and intervention groups will be enrolled during two separate study periods, with training of the research nurses in discharge discharge taking place between the two enrollment periods.
- Masking
- None (open label)
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Sophie CHERILLAT, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706543
- Sponsor's protocol ID
- PHRIP 2024 CHERILLAT
- Other IDs
- 2025-A02457-42
- Acronym
- EDUSOR
- Status last verified
- Nov 2026
- First submitted
- 10 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992Manning S. Bridging the gap between hospital and home: a new model of care for reducing readmission rates in chronic heart failure. J Cardiovasc Nurs. 2011 Sep-Oct;26(5):368-76. doi: 10.1097/JCN.0b013e318202b15c.
PubMed 21273905Paul S. Hospital discharge education for patients with heart failure: what really works and what is the evidence? Crit Care Nurse. 2008 Apr;28(2):66-82. No abstract available.
PubMed 18378729Hill CA. Acute heart failure: too sick for discharge teaching? Crit Care Nurs Q. 2009 Apr-Jun;32(2):106-11. doi: 10.1097/CNQ.0b013e3181a27ccd.
PubMed 19300074Albano MG, Gagnayre R, de Andrade V, d'Ivernois JF. L'education precedant la sortie de l'hopital : nouvelle forme d'education therapeutique. Criteres de qualite et perspectives d'application a notre contexte. Rech Soins Infirm. 2020;141(2):70-77. doi: 10.3917/rsi.141.0070. French.
PubMed 35724034Koelling TM, Johnson ML, Cody RJ, Aaronson KD. Discharge education improves clinical outcomes in patients with chronic heart failure. Circulation. 2005 Jan 18;111(2):179-85. doi: 10.1161/01.CIR.0000151811.53450.B8. Epub 2005 Jan 10.
PubMed 15642765Oh EG, Lee HJ, Yang YL, Lee S, Kim YM. Development of a discharge education program using the teach-back method for heart failure patients. BMC Nurs. 2021 Jun 24;20(1):109. doi: 10.1186/s12912-021-00622-2.
PubMed 34167537Baldewijns K, Boyne J, Rohde C, de Maesschalck L, Deville A, Brandenburg V, De Bleser L, Derickx M, Bektas S, Brunner-La Rocca HP. What kind of patient education and self-care support do patients with heart failure receive, and by whom? Implementation of the ESC guidelines for heart failure in three European regions. Heart Lung. 2023 Jan-Feb;57:25-30. doi: 10.1016/j.hrtlng.2022.07.013. Epub 2022 Aug 19.
PubMed 35994805Mattina K, Dabney BW, Linton M. The Impact of Nurse Education on Heart Failure Readmissions and Patient Education. J Dr Nurs Pract. 2021 Jan 19:JDNP-D-19-00076. doi: 10.1891/JDNP-D-19-00076. Online ahead of print.
PubMed 33468611Lambrinou E, Kalogirou F, Lamnisos D, Sourtzi P. Effectiveness of heart failure management programmes with nurse-led discharge planning in reducing re-admissions: a systematic review and meta-analysis. Int J Nurs Stud. 2012 May;49(5):610-24. doi: 10.1016/j.ijnurstu.2011.11.002. Epub 2011 Dec 22.
PubMed 22196054Boisvert S, Francoeur J, Gallani MC. Cross-Cultural Adaptation and Reliability of the French-Canadian Version of the European Heart Failure Self-Care Behaviour Scale-9. J Nurs Meas. 2019 Dec 1;27(3):458-477. doi: 10.1891/1061-3749.27.3.458.
PubMed 31871285Martin-Latry K, Latry P, Pucheu Y, Couffinhal T. [Hospital medication adherence scale development in cardiovascular disorders]. Ann Pharm Fr. 2021 Jul;79(4):457-464. doi: 10.1016/j.pharma.2020.11.008. Epub 2020 Dec 10. French.
PubMed 33309605Pellet J, Weiss M, Zuniga F, Mabire C. Improving patient activation with a tailored nursing discharge teaching intervention for multimorbid inpatients: A quasi-experimental study. Patient Educ Couns. 2024 Jan;118:108024. doi: 10.1016/j.pec.2023.108024. Epub 2023 Oct 18.
PubMed 37862876Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252Higginson IJ, Gao W, Jackson D, Murray J, Harding R. Short-form Zarit Caregiver Burden Interviews were valid in advanced conditions. J Clin Epidemiol. 2010 May;63(5):535-42. doi: 10.1016/j.jclinepi.2009.06.014.
PubMed 19836205
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Therapeutic Patient Education Program for Discharge (ETPsh) by Nurses in a French Hospital Setting Among Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07706543
- Acronym / sponsor ID
- EDUSOR / PHRIP 2024 CHERILLAT
- Conditions
- Heart Failure
- Keywords
- Heart failure, Discharge education, Nurses, Therapeutic education as topic, Readmission
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 29 Oct 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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. Participants in the control and intervention groups will be enrolled during two separate study periods, with training of the research nurses in discharge discharge taking place between the two enrollment periods.
| Arm | Type | Receives |
|---|---|---|
| Standard therapeutic patient education group | No intervention | –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. |
| Discharge education group | Experimental | Behavioral: Nurse-led discharge educationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led discharge educationThe 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. | Behavioural | Discharge education group |
Primary outcome
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"
24 secondary outcomes
Unplanned rehospitalizations, including emergency department visits, for heart failure.
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
Time frame: At 30 days after hospital discharge
Number of scheduled readmissions not carried out.
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
Number of scheduled consultations with a cardiologist (including appointments made)
Time frame: At 30 days after hospital discharge
Daily adherence to cardiovascular medication
Time frame: At baseline
Daily adherence to cardiovascular medication
Time frame: 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
Heart failure self-care behaviors
Time frame: At baseline
Heart failure self-care behaviors
Time frame: 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
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
Time frame: At baseline
Self-perceived patient competence in disease management
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
Time frame: 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
Anxiety and depression of patients
Time frame: At baseline
Anxiety and depression of patients
Time frame: At 30 days after hospital discharge
Informal caregiver burden
Time frame: At baseline
Informal caregiver burden
Time frame: At 30 days after hospital discharge
Cost of training nurses in discharge education
Time frame: 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 the telephone follow-up call(s) 7 days after hospital discharge (euros)
Time frame: At 30 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Background: PubMed 21273905Manning S. Bridging the gap between hospital and home: a new model of care for reducing readmission rates in chronic heart failure. J Cardiovasc Nurs. 2011 Sep-Oct;26(5):368-76. doi: 10.1097/JCN.0b013e318202b15c.
- Background: PubMed 18378729Paul S. Hospital discharge education for patients with heart failure: what really works and what is the evidence? Crit Care Nurse. 2008 Apr;28(2):66-82. No abstract available.
- Background: PubMed 19300074Hill CA. Acute heart failure: too sick for discharge teaching? Crit Care Nurs Q. 2009 Apr-Jun;32(2):106-11. doi: 10.1097/CNQ.0b013e3181a27ccd.
- Background: PubMed 35724034Albano MG, Gagnayre R, de Andrade V, d'Ivernois JF. L'education precedant la sortie de l'hopital : nouvelle forme d'education therapeutique. Criteres de qualite et perspectives d'application a notre contexte. Rech Soins Infirm. 2020;141(2):70-77. doi: 10.3917/rsi.141.0070. French.
- Background: PubMed 15642765Koelling TM, Johnson ML, Cody RJ, Aaronson KD. Discharge education improves clinical outcomes in patients with chronic heart failure. Circulation. 2005 Jan 18;111(2):179-85. doi: 10.1161/01.CIR.0000151811.53450.B8. Epub 2005 Jan 10.
- Background: PubMed 34167537Oh EG, Lee HJ, Yang YL, Lee S, Kim YM. Development of a discharge education program using the teach-back method for heart failure patients. BMC Nurs. 2021 Jun 24;20(1):109. doi: 10.1186/s12912-021-00622-2.
- Background: PubMed 35994805Baldewijns K, Boyne J, Rohde C, de Maesschalck L, Deville A, Brandenburg V, De Bleser L, Derickx M, Bektas S, Brunner-La Rocca HP. What kind of patient education and self-care support do patients with heart failure receive, and by whom? Implementation of the ESC guidelines for heart failure in three European regions. Heart Lung. 2023 Jan-Feb;57:25-30. doi: 10.1016/j.hrtlng.2022.07.013. Epub 2022 Aug 19.
- Background: PubMed 33468611Mattina K, Dabney BW, Linton M. The Impact of Nurse Education on Heart Failure Readmissions and Patient Education. J Dr Nurs Pract. 2021 Jan 19:JDNP-D-19-00076. doi: 10.1891/JDNP-D-19-00076. Online ahead of print.
- Background: PubMed 22196054Lambrinou E, Kalogirou F, Lamnisos D, Sourtzi P. Effectiveness of heart failure management programmes with nurse-led discharge planning in reducing re-admissions: a systematic review and meta-analysis. Int J Nurs Stud. 2012 May;49(5):610-24. doi: 10.1016/j.ijnurstu.2011.11.002. Epub 2011 Dec 22.
- Background: PubMed 31871285Boisvert S, Francoeur J, Gallani MC. Cross-Cultural Adaptation and Reliability of the French-Canadian Version of the European Heart Failure Self-Care Behaviour Scale-9. J Nurs Meas. 2019 Dec 1;27(3):458-477. doi: 10.1891/1061-3749.27.3.458.
- Background: PubMed 33309605Martin-Latry K, Latry P, Pucheu Y, Couffinhal T. [Hospital medication adherence scale development in cardiovascular disorders]. Ann Pharm Fr. 2021 Jul;79(4):457-464. doi: 10.1016/j.pharma.2020.11.008. Epub 2020 Dec 10. French.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Sophie CHERILLAT principal investigator
University Hospital, Clermont-Ferrand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led discharge education in people with Heart Failure, run by University Hospital, Clermont-Ferrand at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned all-cause rehospitalizations, including emergency department visits. (time frame: At 30 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07706543, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.