Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:26 AM
Study NCT ID:
NCT07451457
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of a Structured Patient Education Programme in the Complex Care of Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-28', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2026-02-28', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' knowledge on heart failure, self-care and emergency conditions", 'timeFrame': 'At 3-, 6-, 12 months', 'description': '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.'}, {'measure': "Patients' knowledge on heart failure, self-care and emergency conditions", 'timeFrame': 'At 3, 6, 12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The impact of the patient education programme on changes in daily self-care practices', 'timeFrame': 'At 3, 6, 12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'patient education programme', 'self-care'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '15718176', 'type': 'BACKGROUND', 'citation': 'Stromberg A. The crucial role of patient education in heart failure. Eur J Heart Fail. 2005 Mar 16;7(3):363-9. doi: 10.1016/j.ejheart.2005.01.002.'}, {'pmid': '32483830', 'type': 'BACKGROUND', 'citation': 'Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. Eur J Heart Fail. 2020 Aug;22(8):1342-1356. doi: 10.1002/ejhf.1858. Epub 2020 Jun 1.'}, {'pmid': '19147463', 'type': 'BACKGROUND', 'citation': 'Jaarsma T, Arestedt KF, Martensson J, Dracup K, Stromberg A. The European Heart Failure Self-care Behaviour scale revised into a nine-item scale (EHFScB-9): a reliable and valid international instrument. Eur J Heart Fail. 2009 Jan;11(1):99-105. doi: 10.1093/eurjhf/hfn007.'}, {'pmid': '38606657', 'type': 'BACKGROUND', 'citation': 'Mullens W, Damman K, Dhont S, Banerjee D, Bayes-Genis A, Cannata A, Chioncel O, Cikes M, Ezekowitz J, Flammer AJ, Martens P, Mebazaa A, Mentz RJ, Miro O, Moura B, Nunez J, Ter Maaten JM, Testani J, van Kimmenade R, Verbrugge FH, Metra M, Rosano GMC, Filippatos G. Dietary sodium and fluid intake in heart failure. A clinical consensus statement of the Heart Failure Association of the ESC. Eur J Heart Fail. 2024 Apr;26(4):730-741. doi: 10.1002/ejhf.3244. Epub 2024 Apr 12.'}, {'pmid': '37622666', 'type': 'BACKGROUND', 'citation': 'McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, 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, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.'}, {'pmid': '24797119', 'type': 'BACKGROUND', 'citation': 'Boyde M, Peters R. Education material for heart failure patients: what works and what does not? Curr Heart Fail Rep. 2014 Sep;11(3):314-20. doi: 10.1007/s11897-014-0200-1.'}, {'pmid': '28233442', 'type': 'BACKGROUND', 'citation': 'Van Spall HGC, Rahman T, Mytton O, Ramasundarahettige C, Ibrahim Q, Kabali C, Coppens M, Brian Haynes R, Connolly S. Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta-analysis. Eur J Heart Fail. 2017 Nov;19(11):1427-1443. doi: 10.1002/ejhf.765. Epub 2017 Feb 24.'}, {'pmid': '32945600', 'type': 'BACKGROUND', 'citation': 'Jaarsma T, Hill L, Bayes-Genis A, La Rocca HB, Castiello T, Celutkiene J, Marques-Sule E, Plymen CM, Piper SE, Riegel B, Rutten FH, Ben Gal T, Bauersachs J, Coats AJS, Chioncel O, Lopatin Y, Lund LH, Lainscak M, Moura B, Mullens W, Piepoli MF, Rosano G, Seferovic P, Stromberg A. Self-care of heart failure patients: practical management recommendations from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2021 Jan;23(1):157-174. doi: 10.1002/ejhf.2008. Epub 2020 Oct 20.'}, {'pmid': '21148593', 'type': 'BACKGROUND', 'citation': 'Lainscak M, Blue L, Clark AL, Dahlstrom U, Dickstein K, Ekman I, McDonagh T, McMurray JJ, Ryder M, Stewart S, Stromberg A, Jaarsma T. Self-care management of heart failure: practical recommendations from the Patient Care Committee of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2011 Feb;13(2):115-26. doi: 10.1093/eurjhf/hfq219. Epub 2010 Dec 10.'}, {'pmid': '22196054', 'type': 'BACKGROUND', 'citation': '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': '11576977', 'type': 'BACKGROUND', 'citation': 'Blue L, Lang E, McMurray JJ, Davie AP, McDonagh TA, Murdoch DR, Petrie MC, Connolly E, Norrie J, Round CE, Ford I, Morrison CE. Randomised controlled trial of specialist nurse intervention in heart failure. BMJ. 2001 Sep 29;323(7315):715-8. doi: 10.1136/bmj.323.7315.715.'}, {'pmid': '24862840', 'type': 'BACKGROUND', 'citation': 'Feltner C, Jones CD, Cene CW, Zheng ZJ, Sueta CA, Coker-Schwimmer EJ, Arvanitis M, Lohr KN, Middleton JC, Jonas DE. Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med. 2014 Jun 3;160(11):774-84. doi: 10.7326/M14-0083.'}, {'pmid': '26873943', 'type': 'BACKGROUND', 'citation': 'Jonkman NH, Westland H, Groenwold RH, Agren S, Atienza F, Blue L, Bruggink-Andre de la Porte PW, DeWalt DA, Hebert PL, Heisler M, Jaarsma T, Kempen GI, Leventhal ME, Lok DJ, Martensson J, Muniz J, Otsu H, Peters-Klimm F, Rich MW, Riegel B, Stromberg A, Tsuyuki RT, van Veldhuisen DJ, Trappenburg JC, Schuurmans MJ, Hoes AW. Do Self-Management Interventions Work in Patients With Heart Failure? An Individual Patient Data Meta-Analysis. Circulation. 2016 Mar 22;133(12):1189-98. doi: 10.1161/CIRCULATIONAHA.115.018006. Epub 2016 Feb 12.'}, {'pmid': '34447992', 'type': 'BACKGROUND', 'citation': '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': '35150240', 'type': 'BACKGROUND', 'citation': 'Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013. Erratum In: Cardiovasc Res. 2023 Jun 13;119(6):1453. doi: 10.1093/cvr/cvad026.'}, {'pmid': '28834669', 'type': 'BACKGROUND', 'citation': 'Ponikowski P, Anker SD, AlHabib KF, Cowie MR, Force TL, Hu S, Jaarsma T, Krum H, Rastogi V, Rohde LE, Samal UC, Shimokawa H, Budi Siswanto B, Sliwa K, Filippatos G. Heart failure: preventing disease and death worldwide. ESC Heart Fail. 2014 Sep;1(1):4-25. doi: 10.1002/ehf2.12005.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nAim 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.\n\nStudy 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.\n\nThe aims are:\n\n1. To analyse the impact of the patient education programme on knowledge related to heart failure and self-care;\n2. To analyse the impact of the patient education programme on the retention of knowledge related to heart failure and self-care;\n3. To analyse the impact of the patient education programme on self-care and changes in the practice of daily self-care activities;\n4. 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients\n* 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\n* Participate voluntarily in a complex, structured heart failure patient education programme between June 1, 2023, and December 31, 2026.\n\nExclusion Criteria:\n\n• There are no exclusion criteria other than the patient's refusal to participate in the study."}, 'identificationModule': {'nctId': 'NCT07451457', 'briefTitle': 'The Role of a Structured Patient Education Programme in the Complex Care of Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Gottsegen National Cardiovascular Institute'}, 'officialTitle': 'The Role of a Structured Patient Education Programme in the Complex Care of Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'BM/15910-1/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patiens participating in a complex, structured heart failure patient education programme', 'description': '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.', 'interventionNames': ['Behavioral: Complex, structured patient education programme']}], 'interventions': [{'name': 'Complex, structured patient education programme', 'type': 'BEHAVIORAL', 'description': "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.\n\nWe 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.", 'armGroupLabels': ['Patiens participating in a complex, structured heart failure patient education programme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1096', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'Gottsegen National Cardiovascular Center', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'Balázs Muk, MD, PhD', 'role': 'CONTACT', 'email': 'balazs.muk@gokvi.hu', 'phone': '+36306966208'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gottsegen National Cardiovascular Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD; Specialist of Internal Medicine and Cardiology; Heart Physician; Head of the Heart Failure Unit of Gottsegen National Cardiovascular Center, Principal Investigator', 'investigatorFullName': 'Balázs Muk', 'investigatorAffiliation': 'Gottsegen National Cardiovascular Institute'}}}}