Action Towards Health Equity and Improved Air Quality in the Duwamish Valley: A Multilevel Asthma Intervention

NCT06552013 | Recruiting

• 2 other identifiers: STUDY000187351R01ES034749-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized control trial is to learn if box fans and filters can reduce asthma symptoms and improve indoor air quality in children ages 6 - 17 years old with asthma living in the Duwamish Valley, Seattle, Washington. The main question it aims to answer are:

• Do box fans with filters improve asthma symptoms?
• Do box fans with filters improve an objective measure used to monitor lung function known as forced expiratory volume during the first second (FEV1)? Researchers will compare children living in households with high quality filters to those in households with sham filters to see if air quality and asthma symptoms improve. Participants will
• fill out several questionnaires
• monitor their lung function with a peak flow meter
• place an air monitor in their homes to monitor indoor air quality
• run the box fan when they are at home

Conditions

Asthma in Children

Keywords

air quality

Outcome Measures

Primary Outcomes (2)

• Asthma symptoms

  Symptoms are evaluated with the seven-item asthma control questionnaire (ACQ), a validated tool used in children.

  ACQ will be measured weekly for 6 consecutive weeks, two pre-intervention weeks (before box fans have been given to participant) and four weeks while fans are being used in the home. Symptoms will also be assessed at the six month follow-up visit.

• FEV1

  FEV1 is captured with a digital peak flow meter.

  FEV1 measures will be taken daily, once in the morning and once at night for the six week study time frame. Prior to the six month follow up we will ask participants to take three consecutive days of FEV1 measurements, for an additional 6 measures

Secondary Outcomes (3)

• Asthma quality of life

  Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)

• Use of rescue medications

  ACQ will be measured weekly for 6 consecutive weeks, two pre-intervention weeks (before box fans have been given to participant) and four weeks while fans are being used in the home. Symptoms will also be assessed at the six month follow-up visit.

• Health care utilization in the past month

  Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)

Study Arms (2)

Sham filter

EXPERIMENTAL

Participants in this arm will receive a sham filter for their box fans. These filters receive a MERV rating of 1 and only filter very large particles and debris such as lint, hair and insects. These particles have little to no impact on asthma symptoms. MERV stands for "minimum efficiency reporting value" and a filter receives a MERV rating as determined by the American Society of Heating, Refrigeration, and Air-Conditioning Engineers.

Other: Sham filter

MERV 13 filter

EXPERIMENTAL

Participants in this arm will receive a MERV 13 filter for their box fans. MERV 13 filters trap the majority of small particles, as small as 1 micron. It also traps up to 75% of particles that are as small as 0.3 microns.

Other: MERV 13 filter

Interventions

MERV 13 filter OTHER

This is an environmental intervention consisting of a low-cost box fan with a MERV 13 filter placed behind it. The company Lasko makes these fans and other environmental appliances.

MERV 13 filter

Sham filter OTHER

This is an environmental intervention consisting of a low-cost box fan with a sham filter (MERV 1) placed behind it. The company Lasko makes these fans and other environmental appliances.

Sham filter

Eligibility Criteria

• Age: 6 Years - 17 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age (6-17 years)
• poorly controlled physician diagnosed asthma defined as more than four days with asthma symptoms in the past two weeks, use of asthma rescue medication for more than four days in the past two weeks, or health care utilization due to asthma in the past year (hospitalization, emergency room visit, or unscheduled clinic visit)
• living in Georgetown and South Park neighborhoods of Seattle

You may not qualify if:

• children with unstable housing or shared custody arrangements

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Duwamish River Community Coaltion

Seattle, Washington, 98108, United States

RECRUITING

Study Officials

• Anjum Hajat, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anjum Hajat, PhD, MPH

CONTACT

206-685-3618; anjumh@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: School of Public Health

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Health data from our randomized control trial will be shared with interested investigators after the two main results papers from the study have been accepted for publication (one on asthma outcomes and the other on air quality). Since data collection will not be finished until year four of the study and the analysis and writing will take some time, data sharing will likely occur after the grant period has ended.

Locations

US (1)