NCT07451457

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

Recruiting now Last updated 5 March 2026

What this trial tests

trial testing Complex, structured patient education programme in Heart Failure in 1,000 participants. Currently enrolling.

Timeline

1 June 2023

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Gottsegen National Cardiovascular Institute
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	1 June 2023
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Hungary

Drugs / interventions tested

• Complex, structured patient education programme

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Gottsegen National Cardiovascular Institute

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.