NCT07706543

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
19mo left

Started Sep 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

July 15, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

July 10, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

Heart failureDischarge educationNursesTherapeutic education as topicReadmission

Outcome Measures

Primary Outcomes (1)

  • Unplanned all-cause rehospitalizations, including emergency department visits.

    Rehospitalization is defined as "an unplanned hospital stay of at least one overnight stay"

    At 30 days after hospital discharge

Secondary Outcomes (22)

  • Unplanned rehospitalizations, including emergency department visits, for heart failure.

    At 30 days after hospital discharge

  • Patient death

    At 30 days after hospital discharge

  • Patient satisfaction of the hospital discharge organization

    At 30 days after hospital discharge

  • Scheduled rehospitalizations that were not completed.

    At 30 days after hospital discharge

  • Number of consultations with the patient's primary care physician.

    At 30 days after hospital discharge

  • +17 more secondary outcomes

Study Arms (2)

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.

Behavioral: Nurse-led discharge education

Interventions

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.

Discharge education group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Poitiers

Poitiers, France

Location

CH Vichy

Vichy, France

Location

Related Publications (19)

  • 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.

    PMID: 34447992BACKGROUND
  • Manning 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.

    PMID: 21273905BACKGROUND
  • Paul 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.

    PMID: 18378729BACKGROUND
  • Hill 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.

    PMID: 19300074BACKGROUND
  • Albano 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.

    PMID: 35724034BACKGROUND
  • Koelling 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.

    PMID: 15642765BACKGROUND
  • Oh 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.

    PMID: 34167537BACKGROUND
  • Baldewijns 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.

    PMID: 35994805BACKGROUND
  • Mattina 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.

    PMID: 33468611BACKGROUND
  • Lambrinou 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.

    PMID: 22196054BACKGROUND
  • Boisvert 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.

    PMID: 31871285BACKGROUND
  • Martin-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.

    PMID: 33309605BACKGROUND
  • Pellet 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.

    PMID: 37862876BACKGROUND
  • Bjelland 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.

    PMID: 11832252BACKGROUND
  • Higginson 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.

    PMID: 19836205BACKGROUND
  • Zannad F, Garcia AA, Anker SD, Armstrong PW, Calvo G, Cleland JG, Cohn JN, Dickstein K, Domanski MJ, Ekman I, Filippatos GS, Gheorghiade M, Hernandez AF, Jaarsma T, Koglin J, Konstam M, Kupfer S, Maggioni AP, Mebazaa A, Metra M, Nowack C, Pieske B, Pina IL, Pocock SJ, Ponikowski P, Rosano G, Ruilope LM, Ruschitzka F, Severin T, Solomon S, Stein K, Stockbridge NL, Stough WG, Swedberg K, Tavazzi L, Voors AA, Wasserman SM, Woehrle H, Zalewski A, McMurray JJ. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. 2013 Oct;15(10):1082-94. doi: 10.1093/eurjhf/hft095. Epub 2013 Jun 19.

    PMID: 23787718BACKGROUND
  • Oh EG, Lee HJ, Yang YL, Kim YM. Effectiveness of Discharge Education With the Teach-Back Method on 30-Day Readmission: A Systematic Review. J Patient Saf. 2021 Jun 1;17(4):305-310. doi: 10.1097/PTS.0000000000000596.

    PMID: 30882616BACKGROUND
  • Tuppin P, Cuerq A, de Peretti C, Fagot-Campagna A, Danchin N, Juilliere Y, Alla F, Allemand H, Bauters C, Drici MD, Hagege A, Jondeau G, Jourdain P, Leizorovicz A, Paccaud F. First hospitalization for heart failure in France in 2009: patient characteristics and 30-day follow-up. Arch Cardiovasc Dis. 2013 Nov;106(11):570-85. doi: 10.1016/j.acvd.2013.08.002. Epub 2013 Oct 18.

    PMID: 24140417BACKGROUND
  • Mowery BD, Brand E, Gisila D, Healy K, Mannaye TA, Bhuvanesh A, Babb R, Bettencourt AP, McLaughlin MK, Russell-Babin K. Improving Discharge Education and Outcomes for Patients with Heart Failure. Am J Nurs. 2025 Mar 1;125(3):40-46. doi: 10.1097/AJN.0000000000000030. Epub 2025 Feb 20.

    PMID: 39972586BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Marie Sophie CHERILLAT

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 15, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

July 15, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations