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

NCT07451457 | Recruiting

• 1 other identifier: BM/15910-1/2025
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To analyse the impact of the patient education programme on knowledge related to heart failure and self-care;
2. 2.To analyse the impact of the patient education programme on the retention of knowledge related to heart failure and self-care;
3. 3.To analyse the impact of the patient education programme on self-care and changes in the practice of daily self-care activities;
4. 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.

Conditions

Heart Failure

Keywords

heart failure; patient education programme; self-care

Outcome Measures

Primary Outcomes (2)

• Patients' knowledge on heart failure, self-care and emergency conditions

  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

  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 Outcomes (1)

• The impact of the patient education programme on changes in daily self-care practices

  At 3, 6, 12 months

Study Arms (1)

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

Interventions

Complex, structured patient education programme BEHAVIORAL

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.

Patiens participating in a complex, structured heart failure patient education programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Gottsegen National Cardiovascular Institute: lead

Study Sites (1)

Gottsegen National Cardiovascular Center

Budapest, 1096, Hungary

RECRUITING

Related Publications (16)

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Balázs Muk, MD, PhD

CONTACT

+36306966208; balazs.muk@gokvi.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD; Specialist of Internal Medicine and Cardiology; Heart Physician; Head of the Heart Failure Unit of Gottsegen National Cardiovascular Center, Principal Investigator

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: March 5, 2026
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)