SMART-School-based Asthma Therapy

University of Rochester

Status: Begins enrollment in 9 months

Conditions: Asthma in Children

Treatments: Behavioral: Usual Care; Behavioral: SMART-SBAT

Study type: Interventional

Funder types: Other

Identifiers

NCT06796387

STUDY00009394

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 2 patient groups

SMART-SBAT

Experimental group

Description:

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.

Treatment:

Behavioral: SMART-SBAT

Usual Care (UC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care