Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
View:

• 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)

Locations
United States
Colorado
Ault-Highland RE-9 school district
RECRUITING
Ault
Colorado Springs 11
RECRUITING
Colorado Springs
Harrison 2 school district
RECRUITING
Colorado Springs
Ellicott 22 school district
RECRUITING
Ellicott
Fountain 8 school district
RECRUITING
Fountain
Granada school district
RECRUITING
Granada
Greeley 6
RECRUITING
Greeley
East Otero R1 school district
RECRUITING
La Junta
Lamar RE2 school district
RECRUITING
Lamar
Las Animas school district
RECRUITING
Las Animas
Manzanola school district
RECRUITING
Manzanola
Weld County RE1
RECRUITING
Platteville
Wiggins RE-50(J)
RECRUITING
Wiggins
Contact Information
Primary
Michaela Brtnikova, PhD
michaela.brtnikova@cuanschutz.edu
303-724-2643
Time Frame
Start Date: 2023-09-21
Estimated Completion Date: 2027-08
Participants
Target number of participants: 500
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov

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