跳至主要内容
临床试验/NCT06513832
NCT06513832进行中(未招募)不适用

Asthma Navigator Intervention to Improve Health Equity in Children

Emory University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
75
试验地点
1
主要终点
Future unscheduled healthcare utilization for asthma exacerbation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Admitted to the PICU for asthma

排除标准

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

研究组 & 干预措施

The Asthma Navigator

Experimental

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.

干预措施: The asthma navigator (Behavioral)

Standard of Care

No Intervention

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.

结局指标

主要结局

Future unscheduled healthcare utilization for asthma exacerbation

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne M Fitzpatrick

Assistant Professor

Emory University

研究点 (1)

Loading locations...

相似试验