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Reducing Asthma Attacks in Disadvantaged School Children With Asthma

RECRUITINGN/ASponsored by University of Colorado, Denver
Actively Recruiting
PhaseN/A
SponsorUniversity of Colorado, Denver
Started2023-09-21
Est. completion2027-05
Eligibility
Age5 Years – 12 Years
Healthy vol.Accepted
Locations13 sites

Summary

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.

Eligibility

Age: 5 Years – 12 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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)

Exclusion Criteria:

* age \< 5 years or \> 12 years
* students with no or controlled asthma

Conditions2

AsthmaAsthma in Children

Locations13 sites

Ault-Highland RE-9 school district
Ault, Colorado, 80610
Colorado Springs 11
Colorado Springs, Colorado, 80907
Harrison 2 school district
Colorado Springs, Colorado, 80916
Ellicott 22 school district
Ellicott, Colorado, 80808
Fountain 8 school district
Fountain, Colorado, 80817

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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