Reducing Asthma Attacks in Disadvantaged School Children With Asthma
Recruiting now · Not applicable
Conditions studied: Asthma in Children
In brief
Our UH3 clinical trial, "Reducing Asthma Attacks in Disadvantaged School Children with Asthma," seeks broad-scale implementation of our effective school-based approach to improve asthma disparities for children, ages 5-12 years, in low-income communities. The investigators will contextualize dissemination and implementation (D\&I) of our Colorado school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school days, while also addressing social determinants of health. Our Better Asthma Control for Kids (BACK) Program will evaluate key metrics identified by diverse stakeholders during this dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S) and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two strategies are designed for sustainable delivery by school asthma navigators and school nurses who coordinate with primary care and community resources. The Exploration, Preparation, Implementation, Sustainment (EPIS) D\&I framework was applied with community partners during the UG3 planning phase to tailor implementation plans that meet local community needs, resources and priorities (EPIS Phases 1 \& 2). BACK-S and BACK-E will be delivered from years 1-3 with data collection for implementation and effectiveness outcomes in 4 Colorado regions. In year 4, the investigators will collect data for sustainment outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine our "dissemination playbook" that guides adoption by other school systems (EPIS Phase 4). Our primary implementation hypothesis is: Reach will be greater among students when delivered using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be more effective than usual care at reducing asthma exacerbations. The BACK playbook includes training materials and a calculation of return on investment. The investigators are targeting schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of Colorado with attention to sustainability. Collectively, our approach will accelerate dissemination of BACK nationally to communities experiencing health inequities in pediatric asthma care.
Key facts
- Study ID
- NCT06003569
- Run by
- University of Colorado, Denver
- People needed
- 300
- Starts
- 2023-09-21
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- students with poor asthma control (or indicators of excess burden on school Asthma Intake Form)
- age 5-12 years of age
- attending one of participating schools in rural Colorado (school selection criteria: high rates of socioeconomic need based on high rates of free-and-reduced lunch or rural status)
You may not qualify if…
- age < 5 years or > 12 years
- students with no or controlled asthma
Where it is running
- Ault-Highland RE-9 school district — Ault, Colorado, United States (enrolling)
- Colorado Springs 11 — Colorado Springs, Colorado, United States (enrolling)
- Harrison 2 school district — Colorado Springs, Colorado, United States (enrolling)
- Ellicott 22 school district — Ellicott, Colorado, United States (enrolling)
- Fountain 8 school district — Fountain, Colorado, United States (enrolling)
- Granada school district — Granada, Colorado, United States (enrolling)
- Greeley 6 — Greeley, Colorado, United States (enrolling)
- East Otero R1 school district — La Junta, Colorado, United States (enrolling)
- Lamar RE2 school district — Lamar, Colorado, United States (enrolling)
- Las Animas school district — Las Animas, Colorado, United States (enrolling)
- Manzanola school district — Manzanola, Colorado, United States (enrolling)
- Weld County RE1 — Platteville, Colorado, United States (enrolling)
- Wiggins RE-50(J) — Wiggins, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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