Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-01 @ 2:03 AM
Study NCT ID:
NCT05926661
Status:
WITHDRAWN
Last Update Posted:
2025-09-19
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Support Tool for Families of High-Risk Children With Heart Disease During Hospital Admission and After Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-25', 'size': 357706, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-03T16:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Per NIH guidelines study does not meet criteria for clinical trial', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-06-21', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of support tool', 'timeFrame': '12 weeks', 'description': 'By administering surveys to 5 families'}, {'measure': 'Feasibility of support tool', 'timeFrame': '12 weeks', 'description': 'By administering surveys to the bed-side nurses and cardiologists.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Disease Congenital']}, 'referencesModule': {'references': [{'pmid': '11082376', 'type': 'BACKGROUND', 'citation': 'Mahle WT, Spray TL, Wernovsky G, Gaynor JW, Clark BJ 3rd. 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Issues Compr Pediatr Nurs. 1996 Jan-Mar;19(1):1-15. doi: 10.3109/01460869609026851.'}, {'pmid': '24973195', 'type': 'BACKGROUND', 'citation': 'Shoemaker SJ, Wolf MS, Brach C. Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information. Patient Educ Couns. 2014 Sep;96(3):395-403. doi: 10.1016/j.pec.2014.05.027. Epub 2014 Jun 12.'}, {'type': 'BACKGROUND', 'citation': 'Vaismoradi MJ, J; Turunen, H; Snelgrove, S. Theme development in qualitative content analysis and thematic analysis. Journal of Nursing Education and Practice. 2016;6:100-110.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to pilot the "support tool" in the Nemours Cardiac Center to assess acceptability and feasibility. This tool will be offered to 5 high-risk families, and they will be asked to complete a survey. In addition, healthcare providers including bed-side nurses and cardiologists will be asked to complete a survey to assess the feasibility of the tool.', 'detailedDescription': "Despite advances in the care of children with heart disease, those affected often remain in need of complex care after hospital discharge. Multiple medications, tube feeds, and medical equipment are a few of the care needs parents face upon leaving the hospital. Unsurprisingly, many parents report problems in the transition of care from the hospital to the home. Clinical providers express frustration related to challenges with family education and communication around the time of discharge. Research is required to identify intervention strategies to improve parent/ caregiver confidence with caring for their child after discharge and reduce unintended resource utilization after discharge including clinical deterioration, unplanned 30-day readmissions, emergency department (ED) visits and nonadherence to outpatient appointments.\n\nIn Aim 1 of the study, the investigators identified the modifiable barriers, perceived needs, and opportunities for intervention to support parents/ caregivers in meeting the care needs of the high-risk child with heart disease after discharge by conducting semi-structured qualitative interviews with parents/ caregivers and healthcare personnel. And based on participants' responses, the investigators developed a support tool to improve parent/ caregiver comfort with caring for the high-risk child and improve post discharge outcomes. The objective of this study is to pilot this support tool in 5 high-risk families in Nemours Cardiac Center and assess the acceptability and feasibility based on their experience."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Parent/Caregiver Group-\n\nInclusion Criteria:\n\n• Parents of a child with congenital heart disease and planned discharge from the Nemours Cardiac Center.\n\nExclusion Criteria:\n\n• Non-English and Non-Spanish speaking families.\n\nThe Healthcare providers group is pre-identified and they will be invited to provide feedback through semi-structured qualitative interviews only. They will not receive any intervention. Their participation will be voluntary.'}, 'identificationModule': {'nctId': 'NCT05926661', 'briefTitle': 'Support Tool for Families of High-Risk Children With Heart Disease During Hospital Admission and After Discharge', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Support Tool for Families of High-Risk Children With Heart Disease During Hospital Admission and After Discharge', 'orgStudyIdInfo': {'id': 'Support Tools'}, 'secondaryIdInfos': [{'id': 'U54GM104941-10', 'link': 'https://reporter.nih.gov/quickSearch/U54GM104941-10', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Parent/Caregiver of high-risk children with heart disease', 'description': 'The parent/caregivers of high-risk children with heart disease coming to the Nemours Cardiac Center for care will be offered a "support tool" and will be asked for it\'s acceptance and feasibility through their experience.', 'interventionNames': ['Other: NCC Support Toolkit']}], 'interventions': [{'name': 'NCC Support Toolkit', 'type': 'OTHER', 'description': 'Pre-discharge intervention-\n\n* Set expectations for parents/caregivers to spend time bedside and attend rounds\n* iPad for the families to use the Nemours App, download education materials and Facetime communication with medical personnel.\n* Download Nemours App and teach them how to use it\n* Education materials- to ease the use of medications, Oxygen and feeding\n* Assistance with transportation, child care, parental work schedule for discharge teaching\n\nPost Discharge intervention (Day 1-2):\n\n• Video/Facetime call with the family to check equipment, home environment and answer questions about medications and formula\n\nPost discharge intervention (Day 3-7):\n\n• Phone call to the family to ensure transportation for their first follow-up appointment, answer questions about medications, Oxygen and feeding.', 'armGroupLabels': ['Parent/Caregiver of high-risk children with heart disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': "Nemours Children's Hospital", 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}], 'overallOfficials': [{'name': 'Deepika Thacker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nemours Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Cardiologist', 'investigatorFullName': 'Deepika Thacker', 'investigatorAffiliation': "Nemours Children's Health System"}}}}