Air Pollution, Risk Reduction Behaviors, Asthma Control, Asthma Exacerbation, Childhood Asthma
Conditions
Keywords
childhood asthma, air quality index, AQI
Brief summary
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.
Interventions
BEHAVIORALEPA-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.
BEHAVIORALCommerical-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.
BEHAVIORALEducation and plan
Standardized outdoor air pollution education and standard asthma action plan
Sponsors
University of Pittsburgh
National Institute of Environmental Health Sciences (NIEHS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Unblinded, randomized controlled parallel trial, stratified by age group (8-12 year, 13-17 year).
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in asthma control scores, over-time, between groups | Baseline through 48 weeks, measured at 4 week intervals | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Asthma Quality of Life (PAQLQ) score over-time between groups | Baseline through 48 weeks, measured at Visit 1 (time=0), Visit 7 (time=24 weeks), and Visit 13 (time=48 weeks). | 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. |
| Severe asthma exacerbations, having at least one, over-time between groups | Baseline through 48 weeks, measured at 4 week intervals | 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. |
Countries
United States
Contacts
CONTACTPediatric Asthma Center
PRINCIPAL_INVESTIGATORFranziska Rosser, MD MPH
University of Pittsburgh
Outcome results
None listed