SMART-School-based Asthma Therapy

SMART-SBAT: Transforming Pediatric Asthma Care Through School-Based Single-Inhaler Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: SMART-SBAT; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill S Halterman, MD, MPH; Phone Number: 5852755798; Email: Jill_halterman@urmc.rochester.edu
• Study Contact Backup: Name: Maria Fagnano, MPH, MS; Phone Number: 5852758220; Email: maria_fagnano@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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.	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 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.
Active Comparator: Usual Care (UC); 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.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of children with one or more acute health care visits due to asthma over 12 months	The percentage of children who experience one or more acute health care visits (emergency, urgent care) for asthma over 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of symptom-free days in prior 14 days	Mean number of symptom-free days (24 hours without symptoms) in prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).	12-month follow-ups
Absenteeism due to asthma	Number of days participant misses school due to asthma	12 months
Program Cost Effectiveness	Evaluation of cost of program per student/participant	12 months
Mean number of nights with asthma symptoms in prior 2 weeks	Mean number of nights with asthma symptoms in the prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).	12 months
Mean number of days requiring use of reliever medication in prior 14 days	Mean number of days requiring reliever therapy in the prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).	12 months
Quality of Life Score at 12 months	Pediatric Asthma Caregiver Quality of Life score at each follow-up. Scores range from1-7, higher scores indicate better quality of life.	12 months
Number of oral corticosteroid bursts and hospitalizations due to asthma symptoms over 12 months	Total number of oral corticosteroid bursts and hospitalizations over 12 months	12 months
FEV1 level	Lung function measured by most recent FEV1 level listed in medical record	12 months
Medication Adherence	Caregiver report of missed doses, school medication administration records, Horne Adherence Scale	12 months
Program Reach	Proportion of eligible students that enroll into SMART-SBAT	12 months
Program Fidelity	Proportion of children where all SMART-SBAT components are delivered (screening, assessment, initiation of SMART-based therapy, and administration of medications in school)	12 months
Program Dose	Mean number of program contacts completed per child	12 months
Program Adoption	Proportion of schools reporting readiness and intent to adopt SMART-SBAT with the availability of a standardized toolkit	12 Months
Asthma Control Score at 12 months	Asthma control score as indicated by the Pediatric Asthma Impairment and Risk Questionnaire (Peds-AIRQ); scores range 0-8; lower scores indicate better asthma control	12 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Michigan State University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: STUDY00009394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All raw data produced in the course of the project will be preserved. All de-identified quantitative analysis datasets will be shared once the main study results have been accepted for publication.

The research data from this project will be deposited within the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR) to ensure that the research community has long-term access to the data, once the main study manuscript has been accepted for publication (or by the end of the grant period; whichever comes first).

• IPD Sharing Time Frame: Data will be made available once the results from the main study aims have been accepted for publication or study closure (whichever comes first), and will remain available for 5 years past the grant end date.

IPD Sharing Access Criteria

Public-use data files: These files, in which direct and indirect identifiers have been removed to minimize disclosure risk, may be accessed directly through the ICPSR website.

Restricted-use data files: These files are distributed in those cases when removing potentially identifying information would significantly impair the analytic potential of the data. Users (and their institutions) must request these files from Dr. Halterman and complete a Data Sharing Agreement. The investigator team will review and approve each request.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No