Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT06388460
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2024-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Asthma Link Effectiveness Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improving Asthma Symptoms', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': "Asthma Control Test to measure child's asthma control on a scale of 0-25. A score of 19 or less is considered poorly controlled asthma."}], 'secondaryOutcomes': [{'measure': 'Improving Medication Adherence', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Survey to measure medication adherence'}, {'measure': 'Improving Healthcare Utilization', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Survey questions to measure # of emergency room visits, # of hospital admissions, # of oral steroid courses due to asthma'}, {'measure': 'Reducing Parental Lost Workdays', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Survey to measure the number of days a parent has missed work'}, {'measure': 'Reducing School Absences', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Survey to measure the number of days a child has missed school'}, {'measure': 'Improving Quality of Life', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Survey to measure the quality of life of the child and parent'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'childhood asthma', 'medication adherence', 'school-supervised asthma therapy', 'real-world'], 'conditions': ['Childhood Asthma']}, 'descriptionModule': {'briefSummary': 'The goal of this cluster Randomized Control Trial is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14.', 'detailedDescription': 'Asthma is an extremely common chronic disease in childhood with significant morbidity. The majority of asthma morbidity in children is due to medication non-adherence, and both morbidity and medication non-adherence disproportionately impact minoritized children. School-supervised asthma therapy ensures that children receive their preventive asthma medication daily at school and has shown efficacy in improving medication adherence and asthma health outcomes, particularly in low-income and racial/ethnic minority children. However, this strategy has not been widely adopted in practice to produce meaningful public health impact. To address this gap, the study team developed a new model, Asthma Link, which partners pediatric practices, schools, and families to deliver school-supervised asthma therapy. This intervention leverages established infrastructure and requires minimal resources to operate, enhancing sustainability in a real-world setting. The pilot trial of Asthma Link showed improved asthma symptoms when compared to an enhanced usual care condition, particularly among low-income, Black and Latino children, and demonstrated trial feasibility. Moreover, the research team has rigorously adapted this intervention for real-world use using input from diverse, multi-level community stakeholders.\n\nThis 14 site cluster randomized controlled trial will determine the effectiveness of Asthma Link versus an enhanced usual care condition in improving asthma health outcomes in school-aged children with poorly controlled asthma.\n\nThe investigators central hypothesis is that children in Asthma Link will have higher Asthma Control Test scores at 6 months compared with children in enhanced usual care; with maintained improvements at 12 months. The secondary hypothesis is that children in Asthma Link will have higher inhaled corticosteroid adherence and quality of life scores, and lower rates of asthma exacerbations, school absences and parental lost workdays compared with children in the enhanced usual care condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'STUDY INCLUSION/EXCLUSION CRITERIA:\n\nChild Inclusion Criteria:\n\n* Meet the eligibility criteria for Asthma Link (as described below)\n* Enrolled in Asthma Link (if randomized to the Asthma Link Condition)\n* Able and willing to provide informed assent\n\nChild Exclusion Criteria:\n\n* Unable or unwilling to provide informed assent\n* Developmental delay that would prevent study participation.\n\nParent Inclusion Criteria:\n\n* Parent/guardian to patient\n* 18 years or older\n* Able to understand and communicate in English or Spanish\n* Able and willing to provide informed consent.\n\nChild eligibility for children enrolled in Asthma Link:\n\n* children aged 5-14 years (enrolled in grade K-8)\n* prescribed daily inhaled corticosteroid (ICS) for asthma\n* Asthma Control Test (ACT) score ≤19 OR 1 or more of ANY of following in the past 1 year: course of oral steroids, hospitalization, Emergency Department visit, sick visit for asthma\n* parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks\n* able and willing to assent\n* parental permission\n* English or Spanish speaking'}, 'identificationModule': {'nctId': 'NCT06388460', 'briefTitle': 'Asthma Link Effectiveness Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'Asthma Link: A Partnership Between Pediatric Practices, Schools, and Families to Improve Medication Adherence and Health Outcomes in Children With Poorly Controlled Asthma', 'orgStudyIdInfo': {'id': 'STUDY00001015'}, 'secondaryIdInfos': [{'id': 'R01HL169229', 'link': 'https://reporter.nih.gov/quickSearch/R01HL169229', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Asthma Link', 'description': "Practices in the Asthma Link condition will receive brief training on how to identify, refer and arrange for children with poorly controlled asthma to receive school-supervised therapy with the child's school health staff. Participants will receive an educational asthma workbook.", 'interventionNames': ['Other: Asthma Link']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': 'Practices in the Enhanced Usual Care condition will receive brief training on how to identify and refer the same group of children with poorly controlled asthma and these children will receive an educational asthma workbook.', 'interventionNames': ['Other: Enhanced Usual Care']}], 'interventions': [{'name': 'Asthma Link', 'type': 'OTHER', 'description': 'Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook', 'armGroupLabels': ['Asthma Link']}, {'name': 'Enhanced Usual Care', 'type': 'OTHER', 'description': 'Providers enroll patients to receive an asthma educational workbook', 'armGroupLabels': ['Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Spano', 'role': 'CONTACT', 'email': 'michelle.spano@umassmed.edu', 'phone': '5088562990'}, {'name': 'MIchelle Trivedi, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Massachusetts Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'centralContacts': [{'name': 'Michelle Trivedi, MD', 'role': 'CONTACT', 'email': 'Michelle.Trivedi3@umassmed.edu', 'phone': '7744418086'}, {'name': 'Michelle Spano, MA', 'role': 'CONTACT', 'email': 'michelle.spano@umassmed.edu', 'phone': '17746966875'}], 'overallOfficials': [{'name': 'Michelle Trivedi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Chan Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michelle Trivedi', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}