SMART-School-based Asthma Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SMART-SBAT, Usual Care.
- Who it may be relevant to
- Registry conditions: Asthma in Children. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SMART-SBAT: Transforming Pediatric Asthma Care Through School-Based Single-Inhaler Therapy
Overview
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.
Detailed description
Despite well-established asthma guidelines and effective preventive medications, many children with persistent asthma do not receive recommended daily anti-inflammatory therapy, and follow-up care with guideline-based step-up adjustments and specialty evaluation is inconsistent. Over a decade ago, in partnership with the Rochester City School District, the investigators co-developed the School-Based Asthma Therapy (SBAT) program to enhance adherence to guideline-based treatment through school-based directly observed therapy (DOT) of preventive medications. Research demonstrated reductions in exacerbations and asthma symptoms, and key stakeholders strongly supported program continuation and scale-up. However, despite its clinical impact, SBAT has not been broadly implemented or sustained outside research trials, and some children continued to have suboptimal asthma control. Recent guideline endorsement of single maintenance and reliever therapy (SMART) offers a timely opportunity to accelerate translation of evidence-based asthma care into real-world practice. SMART simplifies asthma management, improves symptom control, and enables rapid intensification of anti-inflammatory therapy when control remains poor, yet uptake in routine pediatric care remains limited. To address this critical implementation gap and advance pediatric asthma care, the investigators plan to initiate SMART-SBAT, integrating a single ICS-formoterol inhaler at school for both DOT and symptom-driven use. Because school nurses already manage reliever medications, replacing separate controller and reliever inhalers with a single ICS-formoterol inhaler simplifies medication management, facilitates rapid adoption of SMART within existing school health workflows, and enables a "natural" step-up in therapy when symptoms occur. By embedding guideline-recommended SMART delivery in schools, SMART-SBAT provides a pragmatic pathway to accelerate real-world implementation at scale. SMART-SBAT also provides a platform to evaluate treatment response under conditions of reliable medication exposure, including differential effects by asthma phenotype and environmental context, while facilitating specialty evaluation for children with ongoing poor control. Using a pragmatic Type 1 hybrid stepped-wedge trial, the investigators will evaluate effectiveness while simultaneously assessing implementation processes relevant to real-world delivery. Approximately 330 caregivers in SMART-SBAT and usual care schools will be enrolled for longitudinal surveys and medical record reviews to assess outcomes (primary outcome = urgent care and emergency visits for asthma over 12 months). Explanatory mixed-methods analyses will assess reach, fidelity, dose, and adaptations, and evaluate whether baseline clinical characteristics, environmental exposures, and social context modify response to SMART-SBAT. Findings will inform foundational components of a SMART-SBAT toolkit to support broader dissemination. By accelerating uptake of simplified, guideline-based therapy within routine school systems and enabling evaluation beyond adherence barriers, SMART-SBAT aims to reduce exacerbations, improve asthma control, and generate actionable evidence for scalable, high-quality asthma care.
Interventions
- Behavioral SMART-SBAT
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 - Behavioral Usual Care
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 no
Primary outcome measures
- Percentage of children with one or more acute health care visits due to asthma over 12 months [Time frame: 12 months]
Secondary outcome measures (12)
- Mean number of symptom-free days in prior 14 days [Time frame: 12-month follow-ups]
- Mean number of nights with asthma symptoms in prior 2 weeks [Time frame: 12 months]
- Mean number of days requiring use of reliever medication in prior 14 days [Time frame: 12 months]
- Quality of Life Score at 12 months [Time frame: 12 months]
- Asthma Control Score at 12 months [Time frame: 12 months]
- Number of oral corticosteroid bursts and hospitalizations due to asthma symptoms over 12 months [Time frame: 12 months]
- FEV1 level [Time frame: 12 months]
- Absenteeism due to asthma [Time frame: 12 months]
- Medication Adherence [Time frame: 12 months]
- Program Reach [Time frame: 12 months]
- Program Fidelity [Time frame: 12 months]
- Program Dose [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Physician-diagnosed asthma, with moderate-severe persistent symptoms or poor control based on NHLBI criteria
- Age >=6 and =<12 years
- Attending school in Rochester City School District
- Caregiver >=18 years, and is able to understand and speak English or Spanish
Exclusion criteria
- Caregiver inability to speak and understand English or Spanish. (\*Participants unable to read will be eligible, and all instruments will be given verbally.)
- 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.
- In foster care or other situations in which consent cannot be obtained from a guardian.
Based on prior studies, fewer than 10% of subjects are expected to be excluded based on these criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06796387 · STUDY00009394