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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 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.

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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

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

FieldValue
Enrollment Target 500 participants
Start Date 2023-09-21
Est. Completion 2027-08
Phase NA

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT06003569

The ClinicalTrials.gov registry entry for NCT06003569 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 194-participant average among 44 other Asthma in Children trials with a reported enrollment target (158% higher). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 1 distinct geographic area - top geographies include 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.

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