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Active, not recruitingNCT06513832Updated May 22, 2026

Asthma Navigator Intervention to Improve Health Equity in Children

An interventional study of The asthma navigator in Asthma in Children, sponsored by Emory University. Active, not recruiting at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Emory University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Study summary

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.
Read the 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.

02

Conditions studied

  • Asthma in Children

Keywords

  • Asthma self-management
  • Asthma in Children
03

In context

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Admitted to the PICU for asthma

Exclusion criteria

Exclusion Criteria:

  • Cystic fibrosis
  • Immune deficiency
  • Prematurity \<35 weeks
  • Gestation and congenital airway deformities
  • Non-English speaker
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralThe 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.

06

What researchers measure

Primary outcomes

  1. Future unscheduled healthcare utilization for asthma exacerbation

    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).

    Time frame: Baseline, end of study (average of 52 weeks)

Other outcomes

  1. Hospitalization occurrence

    Number of hospitalizations would be measured.

    Time frame: Baseline, end of study (average of 52 weeks)

  2. Clinic follow-up

    Number of clinic follow ups would be measured.

    Time frame: Baseline, end of study (average of 52 weeks)

07

Study locations

1 site
  • Children's Healthcare of Atlanta
    Atlanta, Georgia 30329, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06513832
Lead sponsor
Emory University
Collaborators
Georgia Clinical & Translational Science Alliance
Responsible party
Anne M Fitzpatrick (Assistant Professor, Emory University) — Principal investigator
First posted
Jul 22, 2024
Start date
Jan 17, 2025
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
May 22, 2026

Study contacts

Anne Fitzpatrick, PhD, APRN
principal investigator · Emory University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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