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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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ault-Highland RE-9 school district
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AultUnited StatesUnknown status
Harrison 2 school district
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Colorado SpringsUnited StatesUnknown status
Colorado Springs 11
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Colorado SpringsUnited StatesUnknown status
Ellicott 22 school district
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EllicottUnited StatesUnknown status
Fountain 8 school district
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FountainUnited StatesUnknown status
Granada school district
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GranadaUnited StatesUnknown status
Greeley 6
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GreeleyUnited StatesUnknown status
East Otero R1 school district
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La JuntaUnited StatesUnknown status
Lamar RE2 school district
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LamarUnited StatesUnknown status
Las Animas school district
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Las AnimasUnited StatesUnknown status
Manzanola school district
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ManzanolaUnited StatesUnknown status
Weld County RE1
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PlattevilleUnited StatesUnknown status
Wiggins RE-50(J)
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WigginsUnited StatesUnknown status

Related publications

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