NCT06003569Active, not recruiting
Reducing Asthma Attacks in Disadvantaged School Children With Asthma
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 17 Jul 2023
- Start date
- 21 Sept 2023
- Primary completion date
- May 2027
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Asthma
- NCT number
- NCT06003569
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 21 Sept 2023 to the primary completion date, May 2027
- 13 sites in 1 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.
Age
- age \< 5 years or \> 12 years
Other
- students with no or controlled asthma
Who the study is looking for
- 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)
Age in the registry: 5 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ault-Highland RE-9 school district Coordinator of this site? Confirm its status | Ault | United States | Unknown status |
| Harrison 2 school district Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Colorado Springs 11 Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Ellicott 22 school district Coordinator of this site? Confirm its status | Ellicott | United States | Unknown status |
| Fountain 8 school district Coordinator of this site? Confirm its status | Fountain | United States | Unknown status |
| Granada school district Coordinator of this site? Confirm its status | Granada | United States | Unknown status |
| Greeley 6 Coordinator of this site? Confirm its status | Greeley | United States | Unknown status |
| East Otero R1 school district Coordinator of this site? Confirm its status | La Junta | United States | Unknown status |
| Lamar RE2 school district Coordinator of this site? Confirm its status | Lamar | United States | Unknown status |
| Las Animas school district Coordinator of this site? Confirm its status | Las Animas | United States | Unknown status |
| Manzanola school district Coordinator of this site? Confirm its status | Manzanola | United States | Unknown status |
| Weld County RE1 Coordinator of this site? Confirm its status | Platteville | United States | Unknown status |
| Wiggins RE-50(J) Coordinator of this site? Confirm its status | Wiggins | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.