RECRUITING

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Quick Facts

Study Start:2023-09-21
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06003569

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * students with poor asthma control (or indicators of excess burden on school Asthma Intake Form)
  2. * age 5-12 years of age
  3. * 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)
  1. * age \< 5 years or \> 12 years
  2. * students with no or controlled asthma

Contacts and Locations

Study Contact

Michaela Brtnikova, PhD
CONTACT
303-724-2643
michaela.brtnikova@cuanschutz.edu

Principal Investigator

Stanley Szefler, MD
PRINCIPAL_INVESTIGATOR
Childrens Hospital Colorado

Study Locations (Sites)

Ault-Highland RE-9 school district
Ault, Colorado, 80610
United States
Colorado Springs 11
Colorado Springs, Colorado, 80907
United States
Harrison 2 school district
Colorado Springs, Colorado, 80916
United States
Ellicott 22 school district
Ellicott, Colorado, 80808
United States
Fountain 8 school district
Fountain, Colorado, 80817
United States
Granada school district
Granada, Colorado, 81041
United States
Greeley 6
Greeley, Colorado, 80631
United States
East Otero R1 school district
La Junta, Colorado, 81050
United States
Lamar RE2 school district
Lamar, Colorado, 81052
United States
Las Animas school district
Las Animas, Colorado, 81054
United States
Manzanola school district
Manzanola, Colorado, 81058
United States
Weld County RE1
Platteville, Colorado, 80651
United States
Wiggins RE-50(J)
Wiggins, Colorado, 80654
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Stanley Szefler, MD, PRINCIPAL_INVESTIGATOR, Childrens Hospital Colorado

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-21
Study Completion Date2027-08

Study Record Updates

Study Start Date2023-09-21
Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma in Children