SBAT for Health Equity
School-based Asthma Therapy to Advance Health Equity Among Historically Marginalized Children
1 other identifier
interventional
300
0 countries
N/A
Brief Summary
The goal of this research trial is to: 1) Solidify a population health SBAT implementation strategy with our longstanding community collaborators, 2) Perform a district-wide hybrid type 3, stepped-wedge, cluster randomized trial, and 3) Assess the supportive resource utilization and essential features of SBAT to extend sustainability and fidelity in a cost-effective manner.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2023
CompletedFirst Posted
Study publicly available on registry
February 27, 2023
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2030
Study Completion
Last participant's last visit for all outcomes
December 31, 2030
March 23, 2026
March 1, 2026
4 years
January 23, 2023
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of children on DOT
The percentage of eligible children in schools initiated on guideline-based DOT at the 3 month follow-up.
3 month follow-up
Study Arms (2)
SBAT Implementation
EXPERIMENTALFor schools randomized to implementing SBAT, the program will include the components already available in comparison (usual care) schools (asthma symptom screening forms, access to telemedicine visits, and protocol for initiating DOT), as well as the following elements that will be facilitated with the support of an implementation team: 1. telemedicine asthma visits through school with primary care and/or specialist providers to prescribe needed initial medication as well as medication step-ups for DOT 2. school-based DOT of preventive asthma medications 3. follow-up telemedicine asthma control assessments 4. centralized case management support and care coordination
Usual Care
ACTIVE COMPARATORDuring student health services orientation, the SBAT team will recommend school-based DOT for all children with persistent or poorly controlled asthma, and will provide a simple asthma screening survey to assess symptoms and a written protocol for initiating DOT. Telemedicine visits and DOT are available for all children in the school district, but the implementation team will not help to facilitate these components within the usual care schools.
Interventions
Eligibility Criteria
You may qualify if:
- Physician-diagnosed asthma, with persistent symptoms or poor control based on NHLBI criteria
- Age \>4 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 our prior studies, fewer than 10% of subjects are expected to be excluded based on these criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University at Buffalocollaborator
- University of Rochesterlead
- Michigan State Universitycollaborator
- Virginia Polytechnic Institute and State Universitycollaborator
Central Study Contacts
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
Study Record Dates
First Submitted
January 23, 2023
First Posted
February 27, 2023
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
July 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
March 23, 2026
Record last verified: 2026-03
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.
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).