Pollution Intervention to Impact Kids Asthma Study

University of Pittsburgh351 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

351

Conditions

Childhood Asthma Asthma Control Asthma Exacerbation

Interventions

EPA-AQIBEHAVIORAL

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.

Commerical-AQIBEHAVIORAL

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.

Education and planBEHAVIORAL

Standardized outdoor air pollution education and standard asthma action plan

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in asthma control scores, over-time, between groups

Asthma control will be measured via the validated Asthma Control Test (ACT) and Childhood-ACT (CACT). Asthma control will be evaluated at all study visits (Visits 1-13), every 4 weeks. The ACT will be used for children aged 12 -17 years, the CACT will be used for children aged 8-11 years. The ACT is a 5 question instrument with scores from 5-25, with higher scores generally indicating better control. The CACT is a 7 question instrument with scores from 0-27, with higher scores generally indicating better control. For both ACT and CACT, scores of 19 or less are concerning for poor asthma control and both measure control in the past 4 weeks.

Time frame: Baseline through 48 weeks, measured at 4 week intervals

Secondary Outcomes

Change in Pediatric Asthma Quality of Life (PAQLQ) score over-time between groups

Asthma quality of life will be measured using the validated Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and administered by research coordinators at all in-person visits: randomization (Visit 1), Visit 7 (24 weeks), and exit (Visit 13). The PAQLQ ranges from 1 to 7, with higher scores indicating higher quality of life.

Time frame: Baseline through 48 weeks, measured at Visit 1 (time=0), Visit 7 (time=24 weeks), and Visit 13 (time=48 weeks).

Severe asthma exacerbations, having at least one, over-time between groups

Self-reported severe asthma exacerbations (SAE) will be measured every 4 weeks via questionnaire, administered at all study visits (Visits 1- 13). SAE are defined by American Thoracic Society criteria and include increased asthma symptoms requiring at least 3 days of systemic steroids OR increased asthma symptoms for which Emergency Department or Urgent Care evaluation was sought and for which systemic steroids were administered/prescribed). SAE will be categorized as yes or no for a study visit.