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NCT06796387Not yet recruiting

SMART-School-based Asthma Therapy

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

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
330 (estimated)
First submitted
22 May 2024
Start date
Dec 2026
Primary completion date
Jul 2031
Lead sponsor
University of Rochester
Diseases
Asthma
NCT number
NCT06796387

What you commit to

  • Study type: Interventional
  • Planned participants: 330
  • From Dec 2026 to the primary completion date, Jul 2031
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • Caregiver inability to speak and understand English or Spanish. (\*Participants unable to read will be eligible, and all instruments will be given verbally.)

Who the study is looking for

  • 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

Age in the registry: 6 years to 12 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.