AQI and Childhood Asthma: an Intervention

NCT04454125 | Completed Results

• 1 other identifier: STUDY19120083
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma; Asthma in Children

Keywords

Air Quality Index (AQI); Childhood asthma exacerbations

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active

  Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.

• Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI

  Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.

• Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week

  Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.

Study Arms (2)

Routine Care

ACTIVE COMPARATOR

Other: Routine care

AQI Intervention

EXPERIMENTAL

Behavioral: AQI intervention

Interventions

AQI intervention BEHAVIORAL

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).

AQI Intervention

Routine care OTHER

The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.

Routine Care

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• physician diagnosis of persistent asthma- either mild, moderate, or severe;
• family home internet access and/or smartphone access + willingness to download AirNow app on phone;
• age 8-17 years.

You may not qualify if:

• diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc)
• immunodeficiency- acquired or congenital
• neuromuscular disease
• disability affecting ambulation
• cyanotic congenital heart disease
• only 1 child per household eligible
• no plans to leave Pittsburgh area in next 6 months

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Thoracic Society: collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related 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.

  PMID: 36440347 BACKGROUND

• 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.

  PMID: 36642643 RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Franziska Rosser
• Organization: University of Pittsburgh

franziska.rosser2@chp.edu

412-692-8429

Study Officials

• Franziska Rosser, MD MPH

  UPMC | Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: 40 child will be 1:1 randomization by age groups 8-12 years, 13-17 years.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: July 14, 2020
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: August 31, 2023
• Results First Posted: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)