SMART-School-based Asthma Therapy

NCT06796387 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00009394
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Mean number of symptom-free days in prior 14 days

  12-month follow-ups

• Mean number of nights with asthma symptoms in prior 2 weeks

  12 months

• Mean number of days requiring use of reliever medication in prior 14 days

  12 months

• Quality of Life Score at 12 months

  12 months

• Asthma Control Score at 12 months

  12 months

Study Arms (2)

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.

Behavioral: SMART-SBAT

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.

Behavioral: Usual Care

Interventions

SMART-SBAT BEHAVIORAL

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.

SMART-SBAT

Usual Care BEHAVIORAL

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.

Usual Care (UC)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Michigan State University: collaborator

Central Study Contacts

Jill S Halterman, MD, MPH

CONTACT

5852755798; jill_halterman@urmc.rochester.edu

Maria Fagnano, MPH, MS

CONTACT

5852758220; maria_fagnano@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Division Director Pediatrics/General

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: January 28, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.