AQI and Childhood Asthma: an Intervention

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454125
• Other study ID #: STUDY19120083
• Status: Completed
• Phase: N/A
• Start date: July 14, 2020
• Est. completion date: March 22, 2021

Study information

• Verified date: August 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	American Thoracic Society Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time	Moderate and severe asthma exacerbations were captured via questionnaire administered monthly for up to 6 months. Severe and moderate exacerbations were defined by American Thoracic Society (ATS) criteria.	Over study duration (up to 6 months)
Primary	Mean Change in Asthma Control Over Time	Asthma symptom control was measured by the validated Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) questionnaires as age appropriate (ACT in children 12 year of age or older; CACT for children younger than 12 years of age). ACT and CACT were obtained at baseline and every 4 weeks for up to 6 months. Differences in asthma control scores were compared both within arms and between arms at study end. 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)	Over study duration (up to 6 months)
Primary	Mean Change in Pediatric Asthma Quality of Life Over Time	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)	Baseline, 6 months
Secondary	Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active	Participant reported checking of AQI prior to going outside to be active assessed via questionnaire. Question: In the past 4 weeks, did you check the air quality index before going outside to be active? Response choices: Yes, No.	Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Secondary	Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI	Usage of the AQI prior to exercise was monitored monthly via questionnaire. Question: In the past 4 weeks, how many times did you change your outdoor activity because of the air quality index? Response choices: All of the time, Most of the time, Some of the time, A little of the time, None of the time. A positive response was considered an answer of all, most, some, or a little of the time. A negative response was considered none of the time.	Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Secondary	Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week	Outcome obtained from physical activity questionnaire. Yes represents a positive response to at least one of the follow two questions: Question 1: In a typical week {do you/does SP} do any vigorous-intensity sports, fitness, or recreational activities that cause large increases in breathing or heart rate like running or basketball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative. Question 2: In a typical week, {do you/does SP} do any moderate-intensity sports, fitness, or recreational activities that cause a small increase in breathing or heart rate such as brisk walking, bicycling, swimming, or volleyball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative.	Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.