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Active, Not Recruiting

NCT Number: NCT06513832

Asthma Navigator Intervention to Improve Health Equity in Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma in Children

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The asthma navigator

Behavioral

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.

Primary outcomes

  1. 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).

Other outcomes

  1. Hospitalization occurrence

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

    Number of hospitalizations would be measured.

  2. Clinic follow-up

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

    Number of clinic follow ups would be measured.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Georgia Clinical & Translational Science Alliance

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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