Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 5:30 PM
Study NCT ID:
NCT07055334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-27', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Core Components Finalized in the Home Rehabilitation Scheme Based on Expert Consensus', 'timeFrame': '12 months (from initiation to completion of scheme development)', 'description': 'The home rehabilitation scheme will be developed using a two-round Delphi method with a multidisciplinary expert panel. Each proposed module will be rated by experts for its relevance, feasibility, and clarity. Components reaching ≥75% agreement (rated as "agree" or "strongly agree") will be considered finalized. The outcome will be reported as the number and percentage of components finalized out of all proposed components.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['congenital heart disease', 'home-based cardiac rehabilitation', 'Primary caregiver', 'qualitative research', 'preschool child'], 'conditions': ['Heart Defects, Congenital', 'Rehabilitation', 'Preschool Child', 'Qualitative Research', 'Caregivers', 'Medical Staff, Hospital']}, 'descriptionModule': {'briefSummary': 'This part of the study focuses on understanding the home rehabilitation situation for preschool children with congenital heart disease after operation. Qualitative research interviews with caregivers and medical staff (including doctors, nurses, rehabilitation therapists, nutritionists, and psychologists) are conducted to explore the benefits, obstacles, and professional guidance needs of home rehabilitation. The aim is to summarize the best evidence for home rehabilitation through evidence-based nursing and qualitative research, in order to develop a more comprehensive and suitable home rehabilitation scheme for these children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes three groups. For children with congenital heart disease after surgery, inclusion criteria are age 3 to 7, one-time corrective open-heart surgery in the research unit, and ability to communicate in Chinese. Exclusions are arrhythmia after surgery, other diseases unsuitable for exercise, heart function class IV, and perioperative disorders.\n\nFor caregivers, must be main caregiver, volunteer, spend most time caring, and communicate in Chinese. Exclusions are those who give up treatment, are paid caregivers, have cognitive impairment or mental illness, cannot express feelings, have contradictions with child, or cannot use electronic devices.\n\nFor medical professionals, must hold license and have at least 5 years of related practice. Exclusions are non-frontline staff or those absent in recent year.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Children With Congenital Heart Disease After Surgery\n\nInclusion Criteria:\n\n* Age 3 to 7 years\n* Clinical diagnosis of congenital heart disease\n* Underwent a single open-heart surgical correction under direct vision at the study site\n* Ability to communicate in Chinese\n\nExclusion Criteria:\n\n* Postoperative arrhythmia\n* Comorbid neurological, respiratory, or other systemic diseases\n* Deemed unsuitable for exercise by a physician\n* Cardiac function classified as NYHA Class IV\n* Intellectual, language, or motor impairments resulting from perioperative complications or other causes\n\nCaregivers of Children With Congenital Heart Disease After Surgery\n\nInclusion Criteria:\n\n* Primary caregiver who voluntarily provides care\n* Caregiver who spends the most time with the child\n* Ability to communicate in Chinese\n\nExclusion Criteria:\n\n* Caregivers of children who voluntarily discontinued treatment before completion\n* Paid or professional caregivers\n* Diagnosed cognitive impairment or mental illness\n* Inability to communicate effectively through spoken language\n* Presence of serious conflict or instability in the caregiver-child relationship\n* Inability to independently operate or use smart electronic devices and the internet\n\nMedical Professionals Involved in Congenital Heart Disease Care\n\nInclusion Criteria:\n\n* Licensed healthcare professionals, including physicians, nurses, dietitians, physical therapists, or psychological counselors\n* At least 5 years of professional experience in congenital heart disease care, rehabilitation, or education\n\nExclusion Criteria:\n\n* Not currently engaged in frontline clinical work\n* Not engaged in clinical work within the past year due to leave, study, or reassignment'}, 'identificationModule': {'nctId': 'NCT07055334', 'briefTitle': 'Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Development and Improvement of Home Rehabilitation Scheme for Preschool Children With Congenital Heart Disease After Operation', 'orgStudyIdInfo': {'id': 'LSLL2024-801'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xia Wei, PhD', 'role': 'CONTACT', 'email': 'xiaw23@mail.sysu.edu.cn', 'phone': '+8618823359471'}, {'name': 'Luo Cong, Master', 'role': 'CONTACT', 'email': 'luoc3@mail.sysu.edu.cn', 'phone': '+8619731525206'}], 'overallOfficials': [{'name': 'Xia Wei, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei XIA, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Wei XIA, PhD', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}