Asthma Navigator Intervention to Improve Health Equity in Children

May 19, 2026 updated by: Anne M Fitzpatrick, Emory University

The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are:

  • To identify the factors related to differential experiences of asthma self-management
  • To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite available asthma treatments, nearly 50% of children with asthma experience exacerbations annually, with disadvantaged children, particularly Black and Hispanic, being the most affected. These disparities are largely due to social determinants of health (SDOH), including socioeconomics and family hardship, which explain over 80% of the racial disparities in asthma outcomes. Children in lower opportunity neighborhoods face additional challenges like poor housing and limited green spaces, increasing exposure to pollutants and allergens.

At Children's Healthcare of Atlanta's Pediatric ICU (PICU), 85% of asthma admissions come from low-opportunity areas, with 36.7% having another exacerbation within a year. Significant barriers to better outcomes include limited provider understanding of SDOH and challenges in asthma self-management. Effective asthma self-management, supported by medical providers, is crucial for improving health outcomes in these disadvantaged children.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Children's Healthcare of Atlanta

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Admitted to the PICU for asthma

Exclusion Criteria:

  • Cystic fibrosis
  • Immune deficiency
  • Prematurity <35 weeks
  • Gestation and congenital airway deformities
  • Non-English speaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Asthma Navigator
The Children's electronic medical record (EMR) of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end.
Behavioral: The asthma navigator
The asthma navigator is a Registered Respiratory Therapist and Certified Asthma Educator who will review the care plan at discharge and provide asthma education; assist with follow-up clinic appointment scheduling, medication access, and transportation; and daily as-needed telephone support.
No Intervention: Standard of Care

This arm will not have access to the Asthma Navigator.

The Children's EMR of each child will be screened weekly for up to 52 weeks. When an asthma exacerbation prompting unscheduled healthcare utilization is noted (primary outcome), or at the end of 52 weeks, participant involvement in the study will end.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Future unscheduled healthcare utilization for asthma exacerbation
Time Frame: Baseline, end of study (average of 52 weeks)
The occurrence of unscheduled healthcare utilization and the date and time of occurrence will be assessed through weekly screenings of each child's EMR at Children's (Epic system).
Baseline, end of study (average of 52 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization occurrence
Time Frame: Baseline, end of study (average of 52 weeks)
Number of hospitalizations would be measured.
Baseline, end of study (average of 52 weeks)
Clinic follow-up
Time Frame: Baseline, end of study (average of 52 weeks)
Number of clinic follow ups would be measured.
Baseline, end of study (average of 52 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Georgia Clinical & Translational Science Alliance

Investigators

  • Principal Investigator: Anne Fitzpatrick, PhD, APRN, Emory University

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 Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007482

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All subject-level clinical data at enrollment will be preserved and shared during study completion on 7/31/26. Shared data will be deidentified and original data maintained at the Principal Investigator's institution. Recruitment progress and final study results will be documented at clinicaltrials.gov. Protocols, informed consent forms to participate in the trial and the data dictionary will be shared with the data. Data will be shared with qualified investigators with an appropriate research and approved data use agreement (DUA). Data will be accessed by restricted download once approved.

IPD Sharing Time Frame

At the time of study completion on August 2026

IPD Sharing Access Criteria

Data will be accessed by restricted download once approved.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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