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Asthma Navigator Intervention to Improve Health Equity in Children

Asthma Navigator Intervention to Improve Health Equity in Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06513832
Enrollment
75
Registered
2024-07-22
Start date
2025-01-17
Completion date
2026-08-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children

Keywords

Asthma self-management, Asthma in Children

Brief 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.

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.

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.

Sponsors

Emory University
Lead SponsorOTHER
Georgia Clinical & Translational Science Alliance
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The study team and participants will not be blinded but statistical analyses will be performed in a blinded fashion using allocations of "Intervention A" and "Intervention B." Randomization will be implemented 2:1, in blocks of 6, via a computer algorithm to minimize unintentional imbalances between groups.

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Future unscheduled healthcare utilization for asthma exacerbationBaseline, 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnne Fitzpatrick, PhD, APRN

Emory University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026