[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577291":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":24,"responsibleParty":38,"collaborators":42,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":24,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":24,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":24,"overallStatus":64,"whyStopped":24,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":24},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SMART-SBAT","EXPERIMENTAL","In coordination and approval by the child's primary care or specialist provider, children will receive a single maintenance and reliever therapy (SMART) inhaler for school-based asthma therapy (SBAT). Supervised by the school nurse, children will use their prescribed SMART inhaler each school day for preventive therapy, with additional doses as needed to relieve symptoms. Follow-up control assessments will determine if a step-up in therapy may be warranted, and follow-up provider visits will be initiated through school-based telemedicine or in-person visits. An Asthma Coordination team (nurse and community health worker) will be available to coordinate asthma care between providers, pharmacies, schools and families, and provide additional pragmatic support as needed.",[13],"Behavioral: SMART-SBAT",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care (UC)","ACTIVE_COMPARATOR","Children enrolled in usual care schools will continue to receive asthma management through existing healthcare providers, schools will provide reliever inhalers as prescribed, and preventive asthma therapy is prescribed and delivered through normal channels. Each school year, all school nurses will receive a general orientation on guideline-based asthma management, including SMART and potential benefits of school-based asthma therapy, but standardized workflows or structured coordination will not be available for usual care schools. Caregivers and primary care providers will receive notifications of the child's asthma symptoms and recommendations for SMART therapy.",[19],"Behavioral: Usual Care",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL",[9],null,{"type":22,"name":26,"description":17,"armGroupLabels":27,"otherNames":24},"Usual Care",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Jill S Halterman, MD, MPH","CONTACT","5852755798","jill_halterman@urmc.rochester.edu",{"name":35,"role":31,"phone":36,"phoneExt":24,"email":37},"Maria Fagnano, MPH, MS","5852758220","maria_fagnano@urmc.rochester.edu",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Jill Halterman","Professor of Pediatrics, Division Director Pediatrics\u002FGeneral",[43],{"name":44,"class":6},"Michigan State University","100577291","smart-school-based-asthma-therapy-100577291",false,"NCT06796387","SMART-School-based Asthma Therapy","SMART-SBAT: Transforming Pediatric Asthma Care Through School-Based Single-Inhaler Therapy","Inclusion Criteria:\n\n* Physician-diagnosed asthma, with moderate-severe persistent symptoms or poor control based on NHLBI criteria\n* Age \\>=6 and =\\\u003C12 years\n* Attending school in Rochester City School District\n* Caregiver \\>=18 years, and is able to understand and speak English or Spanish\n\nExclusion Criteria:\n\n* Caregiver inability to speak and understand English or Spanish. (\\*Participants unable to read will be eligible, and all instruments will be given verbally.)\n* Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.\n* In foster care or other situations in which consent cannot be obtained from a guardian.\n\nBased on prior studies, fewer than 10% of subjects are expected to be excluded based on these criteria.","ALL","6 Years","12 Years",{"count":56,"type":57},330,"ESTIMATED","INTERVENTIONAL",[60],"NA","The goal of this research trial is to: 1) Develop a SMART-SBAT protocol specifically designed for schools, 2) Evaluate the effectiveness of SMART-SBAT vs. usual care using a district wide, stepped-wedge type 1 cluster randomized trial and 3) Evaluate the process of implementing SMART-SBAT to contextualize effectiveness outcomes and inform future scale-up.",[63],"Asthma in Children","NOT_YET_RECRUITING","2026-01-27",{"date":67,"type":68},"2026-01-29","ACTUAL",{"date":70,"type":57},"2026-12",{"date":72,"type":57},"2031-12",{"name":5,"class":6}]