Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05480969
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nurse-led Educational Intervention on Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version', 'timeFrame': 'Baseline, 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6', 'timeFrame': 'Baseline, month 6'}, {'measure': 'Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6', 'timeFrame': 'Baseline, month 6'}, {'measure': 'Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6', 'timeFrame': 'Baseline, month 6'}, {'measure': 'Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6', 'timeFrame': 'Baseline, month 6'}, {'measure': 'Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6', 'timeFrame': 'Baseline, month 6'}, {'measure': 'Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6', 'timeFrame': 'Baseline, month 6'}, {'measure': 'Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6', 'timeFrame': 'Baseline, month 6'}, {'measure': 'Time to the first occurrence of a composite of all-cause death or heart failure hospitalization', 'timeFrame': 'Time from randomization to first occurrence (up to 6 months)'}, {'measure': 'Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6', 'timeFrame': 'Baseline, month 6'}, {'measure': 'Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6', 'timeFrame': 'Baseline, month 6'}, {'measure': 'Change in the EuroQol Health-Related Quality of Life Questionnaire EQ-5D three-level version (EQ-5D-3L) (Greek version) from baseline to month 6', 'timeFrame': 'Baseline, month 6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure management programmes', 'Nurse-led educational interventions', 'Self-care', 'Health-related quality of life', 'Caregiver outcomes'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '36510826', 'type': 'DERIVED', 'citation': 'Thodi M, Bistola V, Lambrinou E, Keramida K, Nikolopoulos P, Parissis J, Farmakis D, Filippatos G. A randomized trial of a nurse-led educational intervention in patients with heart failure and their caregivers: impact on caregiver outcomes. Eur J Cardiovasc Nurs. 2023 Oct 19;22(7):709-718. doi: 10.1093/eurjcn/zvac118.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled study to examine the effect of a nurse-led, home/telephone or telephone-only educational intervention on outcomes of heart failure patients and their caregivers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Men or women aged ≥18 years old.\n* Hospitalized for new-onset or decompensated chronic heart failure.\n\nExclusion Criteria:\n\n* Any severe neuromuscular disease or other disability or mobility problems that preclude performance of six-minute walk test.\n* Any severe cognitive dysfunction or psychiatric disease that limit ability to receive education.\n* Patients unable to be contacted by phone or other means.'}, 'identificationModule': {'nctId': 'NCT05480969', 'briefTitle': 'Nurse-led Educational Intervention on Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'officialTitle': 'The Effect of a Nurse-led Educational Intervention on Self-management and Prognosis of Patients With Heart Failure', 'orgStudyIdInfo': {'id': '28/18-01-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group 1', 'description': 'Heart failure educational sessions will be provided by the heart failure-trained nurse to patients and caregivers. These will be delivered through a combination of home visits and telephone calls performed at regular time intervals for a total period of 6 months.', 'interventionNames': ['Other: Heart failure educational intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group 2', 'description': 'Heart failure educational sessions will be provided by the heart failure-trained nurse to patients and caregivers. These will be delivered through telephone calls performed at regular time intervals for a total period of 6 months.', 'interventionNames': ['Other: Heart failure educational intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control patients and caregivers will receive usual care for heart failure.'}], 'interventions': [{'name': 'Heart failure educational intervention', 'type': 'OTHER', 'description': 'Educational intervention constitutes of a face-to-face session delivered before hospital discharge and outpatient sessions on regular intervals for a total of 6 months. Outpatient sessions in Intervention group 1 constitute of two home-based sessions on months 1 and 3, combined with weekly telephone calls during month 1 and bi-weekly calls during months 2-6. Outpatient sessions in Intervention group-2 constitute of weekly telephone sessions during month 1 and bi-weekly calls during months 2-6. The pre-discharge session will address self-monitoring and health awareness. Education will be provided by in-person discussion and through printed supporting material. Caregiver education will include understanding heart failure and advice on how to support their patient, manage their own health and well-being and how to get help when needed. During outpatient sessions, repeat education will be done and evaluation of implementation of self-care activities.', 'armGroupLabels': ['Intervention group 1', 'Intervention group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12461', 'city': 'Chaïdári', 'state': 'Attica', 'country': 'Greece', 'facility': 'Attikon University Hospital', 'geoPoint': {'lat': 38.01135, 'lon': 23.66597}}], 'overallOfficials': [{'name': 'Gerasimos Filippatos, Professor', 'role': 'STUDY_CHAIR', 'affiliation': '2nd Department of Cardiology, Attikon University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registered Nurse', 'investigatorFullName': 'Maria Thodi', 'investigatorAffiliation': 'Attikon Hospital'}}}}