Home Air in Agriculture: Pediatric Intervention Trial

Not Applicable

Completed

• Conditions: Asthma in Children
• Interventions: Device: HEPA air cleaner

• Registration Number: NCT04919915
• Lead Sponsor: University of Washington

Brief Summary

This study seeks to reduce exposure to asthmagens in the homes of a community of Latino children residing in an area of intense agricultural production in Eastern Washington by testing the effectiveness of an intervention (high efficiency particulate air filter- HEPA portable room air cleaners) plus asthma education to reduce indoor measures of particulate matter, ammonia, improve clinically relevant measures of asthma health, and reduce biomarkers of inflammation.

Detailed Description

Over the course of five years, this project's specific aims are as follows:

1. Build on a well-established community based participatory research program to engage community partners in the design, implementation and evaluation of this asthma intervention study.

2. Conduct a year-long intervention study with longitudinal measurement of key asthmagen exposures and health outcome indicators with minimal participant burden.

3. Develop and characterize evaluation metrics for the process, impact and outcomes of this project in achievement of the aims.

4. Promote sustainable public health action via positive and transparent communications about the project to participants, local stakeholders, and state level policy makers through broad-based community outreach.

Study Timeline

• Study Start: 2015-07-14
• Primary Completion: 2019-02-27
• Study Completion: 2019-02-27
• Study First Submitted: 2021-05-19
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-02
• Last Update Submitted: 2021-06-02
• Study First Posted: 2021-06-09
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Eligibility criteria include male and female, poorly controlled asthma, likely to stay in the area over the course of the study, having only one residence, no smokers in the household and residential proximity to dairy operations/crop production (<400 meters) determined by the telephone screening questionnaire.

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Exclusion Criteria

• Prior participation in the Asthma Home Visiting Program, not from the northern third of the lower Yakima Valley, well controlled asthma, unlikely to stay in the are over the course of the study, smokers in the household, no residential proximity to dairy operations or crop production, having more than one residence and inability to communicate over the phone.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	HEPA air cleaner	Households are randomly assigned to the intervention group with asthma education and received two HEPA air cleaners designed to reduce PM and NH3.

Primary Outcome Measures

Name	Time	Method
Change in ammonia (NH3) concentration	1 year (study period)	Indoor air sampling for NH3 collected over a 14-day period. Ogawa passive sampler (Ogawa USA, Pompano Beach, Fl, USA) is left open for 14 days. Measurements collected at beginning and at 1 year after enrollment.
Asthma exacerbation	One year (study period)	Reviewed participant medical records for receipt of prescription for a course of oral corticosteroid.
Clinical utilization	One year (study period)	Caregivers were asked if child had a scheduled or unscheduled ("urgent") clinical visit with a doctor or health care provider, emergency department, or overnight hospitalization for asthma symptoms. Number and types of visits are reported.
Asthma Control Test	At study enrollment	ACT score using the ACT questionnaire
Inflammatory markers of asthma: Fractional exhaled nitric oxide	At study enrollment	Portable NIOX VERO (Aerocrine Inc, Stockholm, Sweden) for direct measurement of fractional exhaled nitric oxide.
Lung function	At study enrollment	Measured lung fuction using EasyOne spirometer (NDD Technologies, Andover, MA). Minimum of three exhalations with acceptable starts, complete exhalation, and no coughs until two exhalations with acceptable repeatability was achieved.
Change in particulate matter 2.5 (PM2.5) concentration	1 year (study period)	Indoor air sampling for PM2.5 collected over a 14-day period. MicroPEM (RTI International, Research Triangle Park, NC, USA) is turn on and left on for 14 days. Measurements collected at beginning and at 1 year after enrollment.
Inflammatory markers of asthma: Urinary leukotriene	1 year (study period)	Measured urinary leukotriene concentration and specific gravity in child urine sample. Measurements collected at enrollment, mid-study (4-6 months after enrollment), and end of study (1 year after enrollment)

Trial Locations

Locations (1)

Yakima Valley Farmworkers Clinic; 🇺🇸 Yakima, Washington, United States