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NCT06003569 · ClinicalTrials.gov registry record · NA
Reducing Asthma Attacks in Disadvantaged School Children With Asthma
A NA study of Asthma in Children, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 13
- Study locations
NCT06003569: Recruiting NA study of Asthma in Children, sponsored by University of Colorado, Denver.
NCT06003569 is a NA study of Asthma in Children that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 500 participants, above the 194-participant average among 44 other Asthma in Children trials with a reported enrollment target (158% higher). The trial reports 13 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06003569, a NA study of Asthma in Children, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 13
- Study locations
Study 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 calculatio
Primary Outcome
% of eligible students enrolled Numerator of Reach = number students consented with confirmed Asthma Intake Form (AIF) eligibility Denominator of Reach = number of eligible students o This denominator includes all students presumed eligible based on AIF at school registration, minus any students determined to NOT be eligible by AIF once the navigator called to confirm eligibility.
Conditions Studied
Interventions
- BEHAVIORAL BACK-S
- BEHAVIORAL BACK-E
Study Locations (13)
Colorado
- Ault-Highland RE-9 school district - Ault
- Colorado Springs 11 - Colorado Springs
- Harrison 2 school district - Colorado Springs
- Ellicott 22 school district - Ellicott
- Fountain 8 school district - Fountain
- Granada school district - Granada
- Greeley 6 - Greeley
- East Otero R1 school district - La Junta
- Lamar RE2 school district - Lamar
- Las Animas school district - Las Animas
- Manzanola school district - Manzanola
- Weld County RE1 - Platteville
- Wiggins RE-50(J) - Wiggins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-09-21 |
| Est. Completion | 2027-08 |
| Phase | NA |
What NCT06003569 shows while recruiting
NCT06003569 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 194-participant average among 44 other Asthma in Children trials with a reported enrollment target (158% higher).
The record links to 1 condition, with Asthma in Children appearing as the primary indexed condition, and to 2 interventions - of which BACK-S is the first listed.
NCT06003569 lists 13 locations in 1 state (Colorado).
Frequently Asked Questions
What is clinical trial NCT06003569 about?
NCT06003569 is a clinical study titled "Reducing Asthma Attacks in Disadvantaged School Children With Asthma". 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 dissemi...
What is the current status of trial NCT06003569?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2023-09-21. Estimated completion is 2027-08.
What conditions does trial NCT06003569 study?
This clinical trial studies the following conditions: Asthma in Children.
What interventions are being tested in trial NCT06003569?
The interventions under investigation include: BACK-S (BEHAVIORAL), BACK-E (BEHAVIORAL).
Who is sponsoring clinical trial NCT06003569?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06003569 being conducted?
This trial has 13 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma in Children
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06003569's enrollment target sits among peer trials
500 3rd of 44 higher than 39 of 44 other Asthma in Children trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma in Children trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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