NCT06320210

Brief Summary

Research has shown that adherence to evidence-based asthma guidelines leads to improved outcomes, yet critical gaps remain in the implementation of these guidelines, particularly among minority and low-income youth. Schools represent a crucial point of intervention, as demonstrated by school-based asthma programs that have addressed individual components of the guidelines with promising results. This project aims to develop, implement, and evaluate a pragmatic, multi-component asthma program that builds upon existing targeted interventions to fully implement the asthma guidelines and integrate them in school practices to foster sustainability. The investigator seeks to understand whether this type of program will improve asthma outcomes at the child and school level.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

March 12, 2024

Last Update Submit

May 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asthma control

    Childhood Asthma Control Test

    Years 1 and 2

Secondary Outcomes (9)

  • Missed work days in parents

    Years 1 and 2

  • Asthma knowledge - parents

    Years 1 and 2

  • Asthma knowledge - child

    Years 1 and 2

  • Asthma quality of life - child

    Years 1 and 2

  • Caregiver quality of life

    Years 1 and 2

  • +4 more secondary outcomes

Study Arms (1)

Children with asthma, parents/guardians of children with asthma, school staff

EXPERIMENTAL

Children will be recruited from two University of Chicago Charter elementary schools. Children with a diagnosis of asthma and their parents will be eligible for inclusion in the study and will specifically be targeted for study recruitment. Staff and administrators at each school will also be recruited through in-person, phone, and email communication, primarily through word of mouth and professional development days. UCCS teachers, staff, and administrators will also be included in the program evaluation and we will obtain appropriate consent. Up to 400 families with a child/children with asthma from two UCCS schools will be added to a registry database. A total of 68 children with a diagnosis of asthma and their parents will be recruited for evaluation of the multi-component program, resulting in a total of 136 children and parents. We will also recruit 24 teachers, staff, and administrators across the two schools to participate in the evaluation of the overall program.

Behavioral: Multicomponent program

Interventions

The intervention is a multi-component program that includes in-depth training for current school teachers/staff who are critical in asthma care, restructured processes to identify students with asthma, technological adaptations to support integrated systems for asthma care and absenteeism, strategies to enhance communication about asthma within school and between school and home, protocols for routine care (e.g., participation in gym/recess) and emergencies, and education for all students about asthma.

Children with asthma, parents/guardians of children with asthma, school staff

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Participants will be included in the study if: 1. The participant either works at, attends, or is the legal guardian of a child who attends one of the two elementary schools included in the study from the University of Chicago Charter Schools - North Kenwood Oakland and Donoghue. 2. The child participant has a diagnosis of asthma OR the parent participant is legal guardian of a child with asthma. 3. The adult stakeholder is 18 years or older. Participants will be excluded from the study if: 1. The participant declines or is unable to provide consent/assent 2. The participant does not speak or read English 3. The participant has already enrolled in the study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Charter Schools

Chicago, Illinois, 60640, United States

RECRUITING

Related Publications (37)

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Study Officials

  • Anna Volerman, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 20, 2024

Study Start

August 31, 2023

Primary Completion

August 31, 2025

Study Completion

December 30, 2025

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations