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

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

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Other: Sham filter; Other: MERV 13 filter

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anjum Hajat, PhD, MPH; Phone Number: 206-685-3618; Email: anjumh@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108
      • Recruiting
      • Duwamish River Community Coaltion
      • Contact: Joseph Santana, MPH; Phone Number: 253-235-9148; Email: joseph@drcc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• children with unstable housing or shared custody arrangements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sham filter; 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; 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.
Experimental: MERV 13 filter; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma quality of life	Will be assessed with the15-item mini-asthma quality of life questionnaire, a validated tool	Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)
Use of rescue medications	This is an item on the ACQ. See primary outcome.	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 assessed with the six-item asthma-related health care utilization questionnaire.	Will be evaluated at baseline (visit 1), after 6 weeks (visit 3) and at 6 month follow up (visit 4)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Anjum Hajat, PhD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: air quality
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: STUDY00018735; 1R01ES034749-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Only de-identified individual level data sets will be shared. Given the small sample size of our study, we will protect against deductive disclosure by withholding information that could result in disclosure.

We will also require interested investigators to provide a proposal that will outline their study question and analytic methods. If there is any overlap with ongoing manuscripts, we will ask investigators to collaborate with ongoing efforts or to propose an alternative study question. Investigators will be required to sign a data sharing agreement that will include assurances about participant privacy and data confidentiality.

We do not anticipate a great number of requests for our data so will handle them on an individual basis. After discussing the data with investigators who are interested in accessing it, we will share it via a secure site.

• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No