Home Air in Agriculture: Pediatric Intervention Trial

NCT ID: NCT04919915

Last Updated: 2021-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-14

Study Completion Date

2019-02-27

Brief Summary

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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

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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.

Conditions

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

HEPA air cleaner

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

The Yakima Valley Farm Workers Clinic

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Catherine Karr

Professor, School of Medicine: Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine Karr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Yakima Valley Farmworkers Clinic

Yakima, Washington, United States

Site Status

Countries

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United States

References

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Masterson EE, Younglove LB, Perez A, Torres E, Krenz JE, Tchong French MI, Riederer AM, Sampson PD, Metwali N, Min E, Jansen KL, Aisenberg G, Babadi RS, Farquhar SA, Thorne PS, Karr CJ. The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods. Contemp Clin Trials. 2020 Sep;96:106085. doi: 10.1016/j.cct.2020.106085. Epub 2020 Jul 25.

Reference Type BACKGROUND
PMID: 32721578 (View on PubMed)

Riederer AM, Krenz JE, Tchong-French MI, Torres E, Perez A, Younglove LR, Jansen KL, Hardie DC, Farquhar SA, Sampson PD, Karr CJ. Effectiveness of portable HEPA air cleaners on reducing indoor PM2.5 and NH3 in an agricultural cohort of children with asthma: A randomized intervention trial. Indoor Air. 2021 Mar;31(2):454-466. doi: 10.1111/ina.12753. Epub 2021 Jan 22.

Reference Type BACKGROUND
PMID: 32996146 (View on PubMed)

Drieling RL, Sampson PD, Krenz JE, Tchong French MI, Jansen KL, Massey AE, Farquhar SA, Min E, Perez A, Riederer AM, Torres E, Younglove LR, Aisenberg E, Andra SS, Kim-Schulze S, Karr CJ. Randomized trial of a portable HEPA air cleaner intervention to reduce asthma morbidity among Latino children in an agricultural community. Environ Health. 2022 Jan 3;21(1):1. doi: 10.1186/s12940-021-00816-w.

Reference Type DERIVED
PMID: 34980119 (View on PubMed)

Other Identifiers

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5R01ES023510-03

Identifier Type: NIH

Identifier Source: secondary_id

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U01EB021923

Identifier Type: NIH

Identifier Source: secondary_id

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P30ES007033

Identifier Type: NIH

Identifier Source: secondary_id

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U2CES026561

Identifier Type: NIH

Identifier Source: secondary_id

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STUDY00001292

Identifier Type: -

Identifier Source: org_study_id

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