Clinical Trials Directory

Trials / Completed

CompletedNCT04454125

AQI and Childhood Asthma: an Intervention

Air Quality Index (AQI) and Childhood Asthma: an Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
All
Age
8 Years – 17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAQI interventionThe 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).
OTHERRoutine careThe routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.

Timeline

Start date
2020-07-14
Primary completion
2021-03-22
Completion
2021-03-22
First posted
2020-07-01
Last updated
2023-08-31
Results posted
2023-08-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04454125. Inclusion in this directory is not an endorsement.