Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:17 AM
Study NCT ID:
NCT07479160
Status:
COMPLETED
Last Update Posted:
2026-03-18
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart to Heart Web-based Communication Program for 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quality of life', 'timeFrame': 'Baseline and 4 weeks after the intervention', 'description': 'Change in quality of life measured by the WHOQOL-BREF questionnaire'}, {'measure': 'Person-centered Care Competence', 'timeFrame': 'Baseline and 4 weeks after the intervention', 'description': 'Change in person-centered care competence measured by the Individualized Care Scale'}], 'secondaryOutcomes': [{'measure': 'Heart Failure Knowledge', 'timeFrame': 'Baseline and 4 weeks after the intervention', 'description': 'Change in heart failure knowledge measured by the Dutch Heart Failure Knowledge Scale'}, {'measure': 'Self-care Behavior', 'timeFrame': 'Baseline and 4 weeks after the intervention', 'description': 'Change in heart failure self-care behavior measured by the European Heart Failure Self-care Behavior Scale (EHFScB-9)'}, {'measure': 'Caregiver Burden', 'timeFrame': 'Baseline and 4 weeks after the intervention', 'description': 'Change in caregiver burden measured by the Burden Scale for Family Caregivers (BSFC-s)'}, {'measure': 'Patient-centered Communication Competence', 'timeFrame': 'Baseline and 4 weeks after the intervention', 'description': 'Change in patient-centered communication competence measured by the Slatore communication scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial evaluates the effectiveness of a web-based family-centered communication enhancement program ("Heart to Heart") designed for patients with heart failure, family caregivers, and cardiac nurses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 19 years or older with a confirmed diagnosis of heart failure for at least one year\n* Receiving outpatient follow-up care in the cardiology clinic\n* Accompanied by a primary family caregiver\n* Able to access and use a web-based platform\n* Family caregivers who are primarily involved in the patient's care and able to use a web-based platform\n* Cardiac nurses with at least three years of clinical experience in the cardiovascular department\n\nExclusion Criteria:\n\n* Individuals unable to use the web-based platform\n* Individuals who declined to participate or did not provide informed consent"}, 'identificationModule': {'nctId': 'NCT07479160', 'briefTitle': 'Heart to Heart Web-based Communication Program for Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Effectiveness of a Web-based Family-Centered Communication Program on Heart Failure Trajectory and Palliative Care: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'M-2024-A0403-00011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heart to Heart Program', 'description': 'Participants receive the "Heart to Heart" web-based communication enhancement program for four weeks. The program includes educational video modules and printable resources designed to improve understanding of heart failure trajectory, goals-of-care conversations, and palliative care communication among patients with heart failure, their family caregivers, and cardiac nurses.', 'interventionNames': ['Behavioral: Heart to Heart Web-based Communication Program']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants receive routine cardiology follow-up and standard education regarding heart failure self-care without access to the web-based communication program during the study period.'}], 'interventions': [{'name': 'Heart to Heart Web-based Communication Program', 'type': 'BEHAVIORAL', 'description': 'A 4-week web-based communication enhancement program consisting of educational video modules and printable resources addressing heart failure trajectory, goals-of-care conversations, and palliative care communication for patients with heart failure, family caregivers, and cardiac nurses.', 'armGroupLabels': ['Heart to Heart Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Medical Center', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong-Ah Ahn', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}