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Purpose

The goal of this clinical trial is to learn if adding Air Quality Index (AQI) information to asthma action plans works to improve asthma outcomes in children. It will also learn about children with asthma who report being more sensitive to outdoor air pollution. The main questions it aims to answer are: - Does adding either information about the EPA-AQI or commercial AQI improve asthma outcomes over time? - Are there changes in nasal gene expression in children with asthma who report they are more sensitive to outdoor air pollution? Researchers will compare EPA-AQI and the commercial-AQI groups to a control group to either AQI works to improve asthma. Participants will: - Receive standardized outdoor air pollution education and an asthma action plan - Provide nose and blood specimens - Have visits every 4 weeks for 48 weeks, 10 will be conducted by telephone calls and 3 visits will be in person.

Conditions

Eligibility

Eligible Ages
Between 8 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A healthcare provider diagnosis of persistent asthma (Steps 2-5 as defined by US guidelines) or intermittent asthma (Step 1) + at least one severe asthma exacerbation (defined by American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria as requiring at least 3 days of systemic steroids or an Emergency Department/Urgent Care visit requiring systemic steroids) in the prior 12 months - Home access to a smartphone or internet - Primary residence in Allegheny County, PA - One participant per household - Age 8 -17 years - Healthcare provider evaluation for asthma in the prior year

Exclusion Criteria

  • Diagnosis of other active chronic respiratory diseases (e.g., cystic fibrosis, bronchopulmonary dysplasia, etc.) - Neuromuscular disorder - Chronic disorder limiting independent ambulation (e.g., spastic quadriplegia, etc.) - Cyanotic heart disease - Plans to relocate from Allegheny County, PA in the next year (12 months) - Use of intranasal or oral/intramuscular/intravenous corticosteroids 4 weeks prior to randomization - Current participation in another asthma intervention trial

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Unblinded, randomized controlled parallel trial, stratified by age group (8-12 year, 13-17 year).
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Control (Standard outdoor air pollution education + asthma action plan) 		Control
  • Behavioral: Education and plan
    Standardized outdoor air pollution education and standard asthma action plan
Experimental
EPA-AQI (Education+ plan + EPA-AQI) 		EPA-AQI
  • Behavioral: EPA-AQI
    The EPA-AQI group will receive standardized outdoor air pollution education, standardized AQI education, instructions for AQI usage, and an asthma action plan containing information specific for the EPA-AQI, and will demonstrate the ability to navigate to the EPA-AQI via smartphone app or website.
  • Behavioral: Education and plan
    Standardized outdoor air pollution education and standard asthma action plan
Experimental
Commercial-AQI (Education+ plan + commercial-AQI) 		Commercial-AQI
  • Behavioral: Commerical-AQI
    The commercial-AQI group will receive standardized AQI education, instructions for commercial-AQI usage, and an asthma action plan containing information specific for the commercial-AQI, and will demonstrate the ability to navigate to the commercial-AQI via smartphone or website.
  • Behavioral: Education and plan
    Standardized outdoor air pollution education and standard asthma action plan

Recruiting Locations

UPMC Children's Hospital of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15224

More Details

Status
Recruiting
Sponsor
University of Pittsburgh

Study Contact

Pediatric Asthma Center
877-296-9026
franziska.rosser2@chp.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.