Clinical trial NCT04454125: AQI and Childhood Asthma: an Intervention
Official title: Air Quality Index (AQI) and Childhood Asthma: an Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Asthma in Children
Keywords: Air Quality Index (AQI)
Childhood asthma exacerbations
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Thoracic Society
First posted: 2020-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 child will be 1:1 randomization by age groups 8-12 years, 13-17 years.
Primary purpose: TREATMENT

Brief summary: 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).

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. 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.

Additionally, 40 parents/guardians of the children were also recruited to complete a baseline parental knowledge and usage of the AQI questionnaire administered at the randomization visit. This was originally listed as a secondary outcome however was removed during reporting of results as parental knowledge is not a true clinical trial outcome. Also, the secondary outcome of baseline child AQI usage (checking AQI) was changed to reflect this was a measure collected at all study visits and the secondary measure of physical activity was added.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time
timeFrame: Over study duration (up to 6 months)
measure: Mean Change in Asthma Control Over Time
timeFrame: Over study duration (up to 6 months)
measure: Mean Change in Pediatric Asthma Quality of Life Over Time
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active
timeFrame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
measure: Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI
timeFrame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
measure: Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week
timeFrame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: UPMC | Children's Hospital of Pittsburgh
name: Franziska Rosser, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reyes-Angel J, Han YY, Forno E, Celedon JC, Rosser FJ. Parental knowledge and usage of air quality in childhood asthma management. Front Pediatr. 2022 Oct 26;10:966372. doi: 10.3389/fped.2022.966372. eCollection 2022.
citation: Rosser FJ, Rothenberger SD, Han YY, Forno E, Celedon JC. Air Quality Index and Childhood Asthma: A Pilot Randomized Clinical Trial Intervention. Am J Prev Med. 2023 Jun;64(6):893-897. doi: 10.1016/j.amepre.2022.12.010. Epub 2023 Jan 13.