HAPI: Home Air in Agriculture: Pediatric Intervention Trial

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT04919915

Collaborator

National Institute of Environmental Health Sciences (NIEHS) (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB) (NIH), The Yakima Valley Farm Workers Clinic (Other)

Enrollment

Location

Arms

43.5

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma in Children	Device: HEPA air cleaner	N/A

Detailed Description

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

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.
Conduct a year-long intervention study with longitudinal measurement of key asthmagen exposures and health outcome indicators with minimal participant burden.
Develop and characterize evaluation metrics for the process, impact and outcomes of this project in achievement of the aims.
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 Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Home Air in Agriculture: Pediatric Intervention Trial

Actual Study Start Date :

Jul 14, 2015

Actual Primary Completion Date :

Feb 27, 2019

Actual Study Completion Date :

Feb 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention group Households are randomly assigned to the intervention group with asthma education and received two HEPA air cleaners designed to reduce PM and NH3.	Device: HEPA air cleaner Participants in the intervention group received two HEPA air cleaners per household. They were informed to place the HEPA air cleaners in the child's bedroom and the living room. Field staff provided and discuss how to use the air cleaner which promoted continuous operation of both air cleaners, keeping the child's bedroom door closed, and selected the highest fan speed. Typical use of the HEPA cleaners were questioned during the mid-study and final visits.
No Intervention: Control group Households are randomly assigned to the control group. They only received the asthma education during the study period. These households receive a HEPA air cleaner at the end of the study.

Arm

Intervention/Treatment

Other: Intervention group

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

Device: HEPA air cleaner

Participants in the intervention group received two HEPA air cleaners per household. They were informed to place the HEPA air cleaners in the child's bedroom and the living room. Field staff provided and discuss how to use the air cleaner which promoted continuous operation of both air cleaners, keeping the child's bedroom door closed, and selected the highest fan speed. Typical use of the HEPA cleaners were questioned during the mid-study and final visits.

No Intervention: Control group

Households are randomly assigned to the control group. They only received the asthma education during the study period. These households receive a HEPA air cleaner at the end of the study.

Outcome Measures

Primary Outcome Measures

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.
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 Control Test [At study enrollment]
ACT score using the ACT questionnaire
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.
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)
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.
Asthma exacerbation [One year (study period)]
Reviewed participant medical records for receipt of prescription for a course of oral corticosteroid.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.