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| ID | Type | Description | Link |
|---|---|---|---|
| R01ES036965 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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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:
Researchers will compare EPA-AQI and the commercial-AQI groups to a control group to either AQI works to improve asthma.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Standard outdoor air pollution education + asthma action plan) | Active Comparator | Control |
|
| EPA-AQI (Education+ plan + EPA-AQI) | Experimental | EPA-AQI |
|
| Commercial-AQI (Education+ plan + commercial-AQI) | Experimental | Commercial-AQI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA-AQI | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through 48 weeks, measured at 4 week intervals |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differential nasal gene expression in children with asthma reporting increased susceptibility to outdoor air pollution | A component of our EPA-AQI and commercial-AQI intervention is to encourage participants to learn their own personal susceptibility to outdoor air pollution. We will assess if participants report symptoms to specific AQI categories at all visits via questionnaire (yes, no). Questionnaires are administered every 4 weeks at all study visits (Visits 1-13). Transcriptome-wide differential gene expression (obtained at baseline visit) will be compared between children who report low susceptibility to specific AQI category versus those who do not, with susceptibility being defined by reported susceptibility during the 48 week study, measured every 4 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pediatric Asthma Center | Contact | 877-296-9026 | franziska.rosser2@chp.edu |
| Name | Affiliation | Role |
|---|---|---|
| Franziska Rosser, MD MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
Select de-identified data will be made available after study completion and as per Data Management and Sharing Plan.
De-identified data generated from this project will be made available no later than the time of publication or the end of the funding period, whichever comes first.
Raw data and identifiable data will not be shared except where institutional agreements, certifications, and informed consent allows. De-identified data will be available by controlled access only within data repositories.
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| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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Unblinded, randomized controlled parallel trial, stratified by age group (8-12 year, 13-17 year).
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| Commerical-AQI | Behavioral | 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. |
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| Education and plan | Behavioral | Standardized outdoor air pollution education and standard asthma action plan |
|
| 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. | Baseline through 48 weeks, measured at 4 week intervals |
| Baseline through 48 weeks, measured at 4 week intervals |