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Wood Smoke Interventions in Native American Populations (EldersAIR)

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ClinicalTrials.gov Identifier: NCT02240069
Recruitment Status : Recruiting
First Posted : September 15, 2014
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Curtis Noonan, University of Montana

Brief Summary:
A critical need exists for efficient community-based interventions aimed at reduction of environmental exposures relevant to health. Biomass smoke exposures due to residential wood heating are common among rural Native American communities, and such exposures have been associated with respiratory disease in susceptible populations. In many of these communities wood stoves are the most economic and traditionally preferred method of residential heating, but resource scarcity can result in burning of improper wood fuels and corresponding high levels of indoor particulate matter. Community-based participatory research techniques will be used to adapt intervention approaches to meet the cultural context of each participating community. At the community level, investigators will facilitate local development of a tribal agency-led wood bank program ensuring that elderly and/or persons with need have access to dry wood for heating. At the household level, investigators will use a three arm randomized placebo-controlled intervention trial to implement and assess education/outreach on best burn practices (Tx1). The content and delivery strategies of the education intervention will be adapted to each community according to stakeholder input. This educational intervention will be evaluated against an indoor air filtration unit arm (Tx2), as well as a placebo arm (Tx3, sham air filters). Tx3 will be used in comparison with the other two treatment arms to evaluate the penetration and efficacy of the community-level wood bank program. Outcomes will be evaluated with respect to changes in pulmonary function measures and respiratory symptoms and conditions among household elders. The investigators hypothesize that locally-designed education-based interventions at the community and household levels will result in efficacious and sustainable strategies for reducing personal exposures to indoor particulate matter, and lead to respiratory health improvements in elderly Native populations. This study will advance knowledge of cost-effective environmental interventions within two unique Native American communities, and inform sustainable multi-level strategies in similar communities throughout the US to improve respiratory health among at-risk populations.

Condition or disease Intervention/treatment Phase
Respiratory; Disorder, Functional, Impaired Respiratory Infection Other Behavioral: Education (Tx1) Device: Air Filtration Unit Treatment (Tx2) Device: Placebo Intervention (Tx3) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Residential Wood Smoke Interventions Improving Health in Native American Populations
Study Start Date : November 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Education (Tx1)
Education on best burn practices
Behavioral: Education (Tx1)
Education on best burn practices

Active Comparator: Air Filtration Unit Treatment (Tx2)
A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.
Device: Air Filtration Unit Treatment (Tx2)
A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove

Sham Comparator: Placebo Intervention (Tx3)
A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.
Device: Placebo Intervention (Tx3)
A 20" x 18" Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter.




Primary Outcome Measures :
  1. Improving measures of pulmonary function [ Time Frame: The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation. ]
    Pre- to post-intervention change in forced expiratory volume at one second (FEV1), forced vital capacity (FVC), FEV1/FVC percent, and post-bronchodilator FEV1.


Secondary Outcome Measures :
  1. Respiratory symptoms and infections [ Time Frame: The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation. ]
    Pre- to post-intervention change in frequency of respiratory symptoms and infections

  2. Wood smoke exposure [ Time Frame: The participants will be followed for four months during each of two successive winter periods for a total of eight months of observation. ]
    Pre- to post-intervention change in indoor PM2.5 concentrations



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Tribal member from one of the two study regions
  • Age 55 years or older.
  • Utilize a wood stove as the primary heating source.
  • Capable and willing to record symptom data and wood stove usage data, as well as complete pulmonary function testing (i.e., spirometry).

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240069


Contacts
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Contact: Curtis W Noonan, Ph.D. 406-243-4957 curtis.noonan@umontana.edu
Contact: Annie Belcourt, Ph.D. 406-243-5454 annie.belcourt@umontana.edu

Locations
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United States, Montana
University of Montana Recruiting
Missoula, Montana, United States, 59812
Principal Investigator: Curtis W Noonan, Ph.D.         
Principal Investigator: Annie Belcourt, Ph.D.         
Principal Investigator: Tony J Ward, Ph.D.         
Sponsors and Collaborators
University of Montana
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Curtis W Noonan, Ph.D. University of Montana
Principal Investigator: Annie Belcourt, Ph.D. University of Montana
Principal Investigator: Tony J Ward, Ph.D. University of Montana

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Responsible Party: Curtis Noonan, Principal Investigator, Professor, University of Montana
ClinicalTrials.gov Identifier: NCT02240069     History of Changes
Other Study ID Numbers: IRB 218-12
R01ES022583 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Respiratory Tract Infections
Respiration Disorders
Infection
Respiratory Tract Diseases