Home Air in Agriculture: Pediatric Intervention Trial (HAPI)

June 2, 2021 updated by: Catherine Karr, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Yakima, Washington, United States, 98902
        • Yakima Valley Farmworkers Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in particulate matter 2.5 (PM2.5) concentration
Time Frame: 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.
1 year (study period)
Change in ammonia (NH3) concentration
Time Frame: 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.
1 year (study period)
Asthma Control Test
Time Frame: At study enrollment
ACT score using the ACT questionnaire
At study enrollment
Clinical utilization
Time Frame: 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.
One year (study period)
Inflammatory markers of asthma: Urinary leukotriene
Time Frame: 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)
1 year (study period)
Inflammatory markers of asthma: Fractional exhaled nitric oxide
Time Frame: At study enrollment
Portable NIOX VERO (Aerocrine Inc, Stockholm, Sweden) for direct measurement of fractional exhaled nitric oxide.
At study enrollment
Asthma exacerbation
Time Frame: One year (study period)
Reviewed participant medical records for receipt of prescription for a course of oral corticosteroid.
One year (study period)
Lung function
Time Frame: 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.
At study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

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

Investigators

  • Principal Investigator: Catherine Karr, MD, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2015

Primary Completion (Actual)

February 27, 2019

Study Completion (Actual)

February 27, 2019

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00001292
  • 5R01ES023510-03 (U.S. NIH Grant/Contract)
  • U01EB021923 (U.S. NIH Grant/Contract)
  • P30ES007033 (U.S. NIH Grant/Contract)
  • U2CES026561 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data has been shared with the NIH Chear Lab as part of U2CES02651

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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