Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-04 @ 6:04 AM
Study NCT ID:
NCT06513832
Status:
RECRUITING
Last Update Posted:
2025-01-23
First Post:
2024-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asthma Navigator Intervention to Improve Health Equity in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study team and participants will not be blinded but statistical analyses will be performed in a blinded fashion using allocations of "Intervention A" and "Intervention B." Randomization will be implemented 2:1, in blocks of 6, via a computer algorithm to minimize unintentional imbalances between groups.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2024-07-15', 'studyFirstSubmitQcDate': '2024-07-19', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospitalization occurrence', 'timeFrame': 'Baseline, end of study (average of 52 weeks)', 'description': 'Number of hospitalizations would be measured.'}, {'measure': 'Clinic follow-up', 'timeFrame': 'Baseline, end of study (average of 52 weeks)', 'description': 'Number of clinic follow ups would be measured.'}], 'primaryOutcomes': [{'measure': 'Future unscheduled healthcare utilization for asthma exacerbation', 'timeFrame': 'Baseline, end of study (average of 52 weeks)', 'description': "The occurrence of unscheduled healthcare utilization and the date and time of occurrence will be assessed through weekly screenings of each child's EMR at Children's (Epic system)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma self-management', 'Asthma in Children'], 'conditions': ['Asthma in Children']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are:\n\n* To identify the factors related to differential experiences of asthma self-management\n* To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.', 'detailedDescription': "Despite available asthma treatments, nearly 50% of children with asthma experience exacerbations annually, with disadvantaged children, particularly Black and Hispanic, being the most affected. These disparities are largely due to social determinants of health (SDOH), including socioeconomics and family hardship, which explain over 80% of the racial disparities in asthma outcomes. Children in lower opportunity neighborhoods face additional challenges like poor housing and limited green spaces, increasing exposure to pollutants and allergens.\n\nAt Children's Healthcare of Atlanta's Pediatric ICU (PICU), 85% of asthma admissions come from low-opportunity areas, with 36.7% having another exacerbation within a year. Significant barriers to better outcomes include limited provider understanding of SDOH and challenges in asthma self-management. Effective asthma self-management, supported by medical providers, is crucial for improving health outcomes in these disadvantaged children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the PICU for asthma\n\nExclusion Criteria:\n\n* Cystic fibrosis\n* Immune deficiency\n* Prematurity \\<35 weeks\n* Gestation and congenital airway deformities\n* Non-English speaker'}, 'identificationModule': {'nctId': 'NCT06513832', 'briefTitle': 'Asthma Navigator Intervention to Improve Health Equity in Children', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Asthma Navigator Intervention to Improve Health Equity in Children', 'orgStudyIdInfo': {'id': 'STUDY00007482'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Asthma Navigator', 'description': "The Children's electronic medical record (EMR) of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end.", 'interventionNames': ['Behavioral: The asthma navigator']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': "This arm will not have access to the Asthma Navigator.\n\nThe Children's EMR of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end."}], 'interventions': [{'name': 'The asthma navigator', 'type': 'BEHAVIORAL', 'description': 'The asthma navigator is a Registered Respiratory Therapist and Certified Asthma Educator who will review the care plan at discharge and provide asthma education; assist with follow-up clinic appointment scheduling, medication access, and transportation; and daily as-needed telephone support.', 'armGroupLabels': ['The Asthma Navigator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Fitzpatrick', 'role': 'CONTACT', 'email': 'anne.fitzpatrick@emory.edu', 'phone': '404-727-9112'}], 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Anne Fitzpatrick, PhD, APRN', 'role': 'CONTACT', 'email': 'anne.fitzpatrick@emory.edu', 'phone': '404-727-9112'}], 'overallOfficials': [{'name': 'Anne Fitzpatrick, PhD, APRN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'At the time of study completion on August 2026', 'ipdSharing': 'YES', 'description': "All subject-level clinical data at enrollment will be preserved and shared during study completion on 7/31/26. Shared data will be deidentified and original data maintained at the Principal Investigator's institution. Recruitment progress and final study results will be documented at clinicaltrials.gov. Protocols, informed consent forms to participate in the trial and the data dictionary will be shared with the data. Data will be shared with qualified investigators with an appropriate research and approved data use agreement (DUA). Data will be accessed by restricted download once approved.", 'accessCriteria': 'Data will be accessed by restricted download once approved.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Georgia Clinical & Translational Science Alliance (CTSA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Anne M Fitzpatrick', 'investigatorAffiliation': 'Emory University'}}}}