AQI and Childhood Asthma: an Intervention

Overview

This is a small pilot prospective intervention trial in children with asthma who will be randomized to receive either (A) Air Quality Index (AQI) education + an asthma action plan (control) or (B) AQI education + an asthma action plan which contains AQI behavioral recommendations + demonstrate ability to navigate to AirNow either online or on smartphone app (intervention).

Full Title of Study: “Air Quality Index (AQI) and Childhood Asthma: an Intervention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 22, 2021

Detailed Description

Over 3 million US children with asthma reported at least one attack in the prior year. Poorly controlled asthma is a major cause of suffering, school absences, loss of caregiver productivity, and healthcare costs (estimated as ~$80 billion/year). Over half of children on controller medication are not well controlled, due to environmental exposures, non-adherence, or true non-response to treatment. Outdoor air pollution is a known trigger of asthma. Although sound health policies are the best long-term approaches to reduce the harmful effects of air pollution, exposure avoidance is needed until "clean air" is ensured through effective legislation. Despite this, healthcare providers infrequently provide pollution exposure advice to children with asthma. The Environmental Protection Agency (EPA) monitors air pollution and reports a daily Air Quality Index (AQI) that is easy to use and available in most metropolitan areas. Practical recommendations regarding outdoor activity can be based on AQI levels. Despite this, AQI-based recommendations are rarely addressed in asthma action plans (AAP). No pediatric study has assessed the addition of the AQI to AAP to reduce asthma morbidity. This proposal seeks to recruit a pilot cohort of 40 children with asthma + 40 parent/guardian. Using this cohort, the investigators will test the hypotheses that (1) the addition of the AQI to AAP will reduce asthma exacerbations and (2) the addition of the AQI to AAP will improve asthma symptom control & quality of life in children with asthma. The inclusion of the AQI onto asthma action plans is novel in clinical asthma care; its wide availability would make large-scale implementation feasible. The investigators expect this low-cost and low-tech intervention will have a positive impact in reducing asthma morbidity. Given that 1 out of every 12 children in the U.S. has asthma, this is relevant to health care professionals, parents, and public health practitioners. Optional, the investigators will collect nasal epithelial cells for use in future genomic/epigenetic studies.

Interventions

  • Behavioral: AQI intervention
    • The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
  • Other: Routine care
    • The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.

Arms, Groups and Cohorts

  • Active Comparator: Routine Care
  • Experimental: AQI Intervention

Clinical Trial Outcome Measures

Primary Measures

  • Change in asthma exacerbations
    • Time Frame: 6 months
    • Moderate and severe asthma exacerbations will be captured monthly via questionnaire. Change in asthma exacerbations from baseline will be evaluated within arms and between arms at 6 months.
  • Change in asthma control symptoms
    • Time Frame: 6 months
    • Asthma symptom control will be measured monthly by the validated Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) questionnaires as age appropriate. Differences in asthma control scores will be compared both within arms and between arms at 6 months. ACT (min=5, max=25, score of <=19 concerning for poor asthma control; <=15 concerning for very poorly controlled) CACT (min=0, max=27, score of <=19 concerning for poor asthma control; <=12 concerning for very poorly controlled)
  • Change in pediatric asthma quality of life
    • Time Frame: 6 months
    • Quality of life will be measured by the validated Pediatric Asthma Quality of Life Questionnaire with standardized activities (PAQLQ) at entrance and exit visits. Differences in PAQLQ scores will be compared both within arms and between arms at study end. PAQLQ (min=1 (extremely bothered/all the time), max=7 (not bothered/none of the time)

Secondary Measures

  • Baseline knowledge AQI
    • Time Frame: At time of enrollment (initial study visit)
    • Baseline parental knowledge of the AQI and usage in child asthma management, baseline child knowledge of AQI assessed via questionnaire.
  • Usage of AQI
    • Time Frame: 6 months
    • Usage of the AQI prior to exercise will be monitored monthly via questionnaire. Secondary analysis will include evaluating self-reported usage of AQI between treatment arms.

Participating in This Clinical Trial

Inclusion Criteria

  • Child Inclusion criteria includes: 1. physician diagnosis of persistent asthma- either mild, moderate, or severe; 2. family home internet access and/or smartphone access + willingness to download AirNow app on phone; 3. age 8-17 years. Parent/guardian inclusion: parent or guardian of the child participant, of whom has met inclusion criteria. Exclusion Criteria:

  • Child exclusion criteria includes: 1. diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc) 2. immunodeficiency- acquired or congenital 3. neuromuscular disease 4. disability affecting ambulation 5. cyanotic congenital heart disease 6. only 1 child per household eligible 7. no plans to leave Pittsburgh area in next 6 months Parental/guardian exclusion criteria:

none.

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Collaborator
    • American Thoracic Society Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Franziska Rosser, MD MPH, Assistant Professor of Pediatrics – University of Pittsburgh
  • Overall Official(s)
    • Franziska Rosser, MD MPH, Principal Investigator, UPMC | Children’s Hospital of Pittsburgh

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