Recruiting

Asthma Management

Sponsor:

University of Colorado, Denver

Code:

NCT06003569

Conditions

Asthma in Children

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

BACK-S

BACK-E

Study Details

Brief 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.

Conditions

Asthma in Children

Study ID

NCT06003569

Start date

Sep 21, 2023

Status verified date

Apr, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not 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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Usual care

School nurses/schools randomized to usual care will continue to receive their usual care from school nurses and then subsequently provide the intervention given their asthma remains poorly controlled at the start of the next school year following enrollment.

experimental: BACK-S

The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).

experimental: BACK-E

The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.

Interventions

BACK-S

BACK = Better Asthma Control for Kids:

The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).

BACK-E

The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.

Primary outcome measure

  • Reach [ Time Frame: Up to 48 months ]

Central Contacts and Locations

Central contacts

Locations

Ault-Highland RE-9 school district

Recruiting

Ault, Colorado, United States, 80610

Contacts

Colorado Springs 11

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

Harrison 2 school district

Recruiting

Colorado Springs, Colorado, United States, 80916

Contacts

Ellicott 22 school district

Recruiting

Ellicott, Colorado, United States, 80808

Contacts

Fountain 8 school district

Recruiting

Fountain, Colorado, United States, 80817

Contacts

Granada school district

Recruiting

Granada, Colorado, United States, 81041

Contacts

Greeley 6

Recruiting

Greeley, Colorado, United States, 80631

Contacts

East Otero R1 school district

Recruiting

La Junta, Colorado, United States, 81050

Contacts

Lamar RE2 school district

Recruiting

Lamar, Colorado, United States, 81052

Contacts

Las Animas school district

Recruiting

Las Animas, Colorado, United States, 81054

Contacts

Manzanola school district

Recruiting

Manzanola, Colorado, United States, 81058

Contacts

Weld County RE1

Recruiting

Platteville, Colorado, United States, 80651

Contacts

Wiggins RE-50(J)

Recruiting

Wiggins, Colorado, United States, 80654

Contacts

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-04-13.