The Role of a Structured Patient Education Programme in the Complex Care of Patients With Heart Failure

February 28, 2026 updated by: Balázs Muk, Gottsegen National Cardiovascular Institute

Background: The 2021 European Society of Cardiology (ESC) Heart Failure Guidelines give a Class I recommendation for all patients with heart failure to be involved in a multidisciplinary heart failure care programme in order to reduce heart failure-related hospitalisations and mortality. In addition, Heart Failure Guidelines emphasize the strategic importance of self-care and learning related tasks for all heart failure patients in order to improve prognosis. The current ESC Heart Failure Guidelines provide clear instructions on what to teach patients as part of a patient education programme, but it does not provide clear guidance on exactly how to do this. However, the position statement published by the ESC Heart Failure Association in 2011 and updated in 2021 provides significant assistance in implementing patient education and self-care into daily practice.

Aim of the study: To analyse the impact of a complex, structured heart failure patient education programme on the acquisition and retention of knowledge related to heart failure and self-care.

Study design:The data of adult patients hospitalised for heart failure at the Heart Failure Unit of the Department of Adult Cardiology, Gottsegen National Cardiovascular Center and at the Division of Cardiology, Department of Cardiology, Faculty of Medicine, University of Debrecen, as well as adult patients treated at the Heart Failure Outpatient Clinics of each Institute - and their relatives - participated in a complex, structured heart failure patient education programme on a voluntary basis were retrospectively and prospectively assessed.

The aims are:

  1. To analyse the impact of the patient education programme on knowledge related to heart failure and self-care;
  2. To analyse the impact of the patient education programme on the retention of knowledge related to heart failure and self-care;
  3. To analyse the impact of the patient education programme on self-care and changes in the practice of daily self-care activities;
  4. To examine the impact of the patient education programme on prognosis. Methodology and organisation of the study: Patients participate in a complex, structured heart failure patient education programme on a voluntary basis between June 1, 2023, and December 31, 2026. The data of these patients will be analysed. Patients and their relatives participate in an interactive program lasting approximately 60 minutes, led jointly by doctors from the Working Groups on Heart Failure and heart failure nurses. The aim of the complex patient education programme is to provide information on the most important and basic facts about heart failure, to teach self-care, and to learn how to recognise emergency conditions, in accordance with the current ESC Heart Failure Guidelines and the position statement of the ESC Heart Failure Association. After the patient education programme, patients and their relatives are provided with written information materials and diagrams summarising the main elements of self-care and strategically important messages presented during the programme, with an emphasis on emergency conditions. Patients complete a questionnaire before, after, and 3, 6, and 12 months after the patient education programme. Completing the questionnaire is voluntary and anonymous. The questionnaire includes basic patient data (e.g., age, highest level of education, previous follow-up for heart failure), IT skills necessary for telemedicine care and consultation, and basic information (e.g., use of computers, smart devices, and the internet). The investigators assess patients' basic knowledge and their understanding of emergency situations using a simple-choice 11-question questionnaire developed by the Working Group on Heart Failure of Gottsegen National Cardiovascular Center. The impact of the patient education programme on changes in daily self-care practices using a questionnaire before and after the patient education programme was also analysed. Self-care is also assessed using the internationally validated 9-item European Heart Failure Self-Care Behaviour Scale (EHFScB-9) before patient education programme and 3, 6, and 12 months after. The patient feedback (rated on a scale of 1 to 5) on the usefulness of the patient education programme and the extent to which it has expanded their knowledge of heart failure was also assessed. During data processing, the basic clinical characteristics of patients, their hemodynamic and laboratory parameters, drug and device therapy, and prognosis (hospitalisation, mortality) were also investigated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

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 Locations

  • Hungary
      • Budapest, Hungary, 1096
        • Recruiting
        • Gottsegen National Cardiovascular Center

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients hospitalised for heart failure at the Heart Failure Unit of the Department of Adult Cardiology, Gottsegen National Cardiovascular Center and at the Division of Cardiology, Department of Cardiology, Faculty of Medicine, University of Debrecen, as well as adult patients treated at the Heart Failure Outpatient Clinics of each Institute are scheduled to participate in a complex, structured heart failure patient education programme between June 1, 2023, and December 31, 2026.

Description

Inclusion Criteria:

  • Adult patients
  • Hospitalised for heart failure at the Heart Failure Unit of the Department of Adult Cardiology, Gottsegen National Cardiovascular Center and at the Division of Cardiology, Department of Cardiology, Faculty of Medicine, University of Debrecen or adult patients treated at the Heart Failure Outpatient Clinics of each Institute
  • Participate voluntarily in a complex, structured heart failure patient education programme between June 1, 2023, and December 31, 2026.

Exclusion Criteria:

• There are no exclusion criteria other than the patient's refusal to participate in the study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patiens participating in a complex, structured heart failure patient education programme
Adult patients hospitalised for heart failure at the Heart Failure Unit of the Department of Adult Cardiology, Gottsegen National Cardiovascular Center and at the Division of Cardiology, Department of Cardiology, Faculty of Medicine, University of Debrecen, as well as adult patients treated at the Heart Failure Outpatient Clinics of each Institute are scheduled to participate in a complex, structured heart failure patient education programme between June 1, 2023, and December 31, 2026.
Behavioral: Complex, structured patient education programme

Patients participate in an interactive patient education programme (PEP) led jointly by doctors from the Working Groups on Heart Failure (HF) and HF nurses. The aim of the PEP is to provide information on the most important and basic facts about HF, to teach self-care, and to learn how to recognise emergency conditions.

We assess patients' basic knowledge and their understanding of emergency situations using a simple-choice 11-question questionnaire developed by the Working Group on HF of Gottsegen National Cardiovascular Center. We also analyse the impact of the PEP on changes in daily self-care practices before and after the PEP. Self-care is also assessed using the internationally validated 9-item European HF Self-Care Behaviour Scale before PEP and 3, 6, and 12 months after. We also assess patient feedback on the usefulness of the PE. During data processing, we also analyse the basic clinical characteristics of patients, drug and device therapy, and prognosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' knowledge on heart failure, self-care and emergency conditions
Time Frame: At 3-, 6-, 12 months
Using a simple-choice 11-question questionnaire developed by the Working Group on Heart Failure of Gottsegen National Cardiovascular Center. Patients answer a simple-choice 11-question questionnaire. Each correct answer is worth 1 point, an incorrect answer is worth 0 points, thus a maximum of 11 points can be reached and a possible score range is 0-11 points. Higher scores indicate better knowledge on heart failure, self-care and emergency conditions.
At 3-, 6-, 12 months
Patients' knowledge on heart failure, self-care and emergency conditions
Time Frame: At 3, 6, 12 months
Using the internationally validated 9-item European Heart Failure Self-Care Behaviour Scale (EHFScB-9). Patients rate 9 items on a scale of 1-5 to indicate how much they agree with their content. A total score of 9-45 can be achieved. Higher scores indicate poorer self-care. For easier interpretation, the total score of the EHFScB-9 is translated into a 0-100 point scale (a higher score indicates more favourable self-care), with a score ≥ 70 indicating adequate self-care according to the literature.
At 3, 6, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of the patient education programme on changes in daily self-care practices
Time Frame: At 3, 6, 12 months
Using a questionnaire on daily self-care practices. Patients answer 6 simple (yes/no) questions about the self-care practices (weekly/daily weight, blood pressure, pulse measurement). A "yes" answer is worth 1 point, a "no" answer is worth 0 points, for a total of 3-6 points. A higher score indicates a more favourable outcome in terms of daily self-care tasks.
At 3, 6, 12 months

Collaborators and Investigators

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

Sponsor

Gottsegen National Cardiovascular Institute

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

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)

June 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM/15910-1/2025

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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