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Wood Smoke Interventions in Native American Populations (EldersAIR)

Primary Purpose

Respiratory; Disorder, Functional, Impaired, Respiratory Infection Other

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education (Tx1)
Air Filtration Unit Treatment (Tx2)
Placebo Intervention (Tx3)
Sponsored by
University of Montana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory; Disorder, Functional, Impaired

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

  • University of Montana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Education (Tx1)

Air Filtration Unit Treatment (Tx2)

Placebo Intervention (Tx3)

Arm Description

Education on best burn practices

A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.

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.

Outcomes

Primary Outcome Measures

Post-intervention FEV1
Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters
Post-intervention FVC
Mean of up to two post-intervention measures of forced vital capacity (FVC), liters
Post-intervention FEV1/FVC Ratio
Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)
Post-intervention Systolic Blood Pressure
Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)
Post-intervention Diastolic Blood Pressure
Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)

Secondary Outcome Measures

Post-intervention Indoor Fine Particulate Matter (PM2.5)
Post-intervention average Indoor fine particulate matter (PM2.5) concentration

Full Information

First Posted
September 10, 2014
Last Updated
November 2, 2022
Sponsor
University of Montana
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
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1. Study Identification

Unique Protocol Identification Number
NCT02240069
Brief Title
Wood Smoke Interventions in Native American Populations
Acronym
EldersAIR
Official Title
Residential Wood Smoke Interventions Improving Health in Native American Populations
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2015 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Montana
Collaborators
National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Rural Native American (NA) communities experience disproportionate disease burden compared to other US populations, with poor indoor air quality resulting from in-home biomass smoke exposures (residential wood stoves) a likely contributor to these health burden discrepancies. Epidemiological studies support the etiological association between indoor biomass smoke exposure and several domains of global disease burden, particularly with respect to pediatric respiratory tract infections and adult chronic obstructive pulmonary disease (COPD) and chronic bronchitis. Elderly populations are particularly susceptible to chronic respiratory conditions, and declining pulmonary function is associated with increased morbidity and mortality. Randomized trials in developing countries have demonstrated the impact that improved cookstove technologies have in reducing biomass smoke exposures and children's risk of acute respiratory infection. However limited knowledge is available regarding the potential improvements in NA elderly populations following wood stove interventions. Today, a critical need exists for efficient community-based interventions aimed at promoting healthy indoor environments in at-risk communities. Financial and logistical barriers that currently exist in rural and economically disadvantaged NA communities prohibit the implementation and sustainability of many environmental health interventions. Regarding wood stoves, qualitative input from experts and Native communities underscores the need for innovative low-cost, sustainable interventions targeting the reduction of in-home biomass smoke exposures. In this proposal, investigators will test community-level and education-based household-level strategies aimed at promoting and implementing best-burn practices to improve air quality and respiratory health in at-risk elderly populations. This proposal represents a multidisciplinary collaboration between university and tribal stakeholders from two Native American Reservations to develop, adapt, implement, and evaluate a two-level intervention to reduce exposure to indoor biomass smoke and improve respiratory health among elderly tribal members. 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 tribal agency-led wood yard and distribution programs ensuring that elderly and/or persons with need have access to dry wood for heating. With community advisory guidance, investigators will use a three arm randomized placebo-controlled intervention trial to implement and assess education on best burn practices (Tx1) at the household level. 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 fuel program. Outcomes will be evaluated with respect to changes in markers of respiratory health among elders and changes in indoor air quality (PM2.5). The investigators hypothesize that locally-designed education-based interventions, in the context of a community-based strategy focused on wood fuels, will result in efficacious and sustainable strategies for reducing personal exposures to indoor biomass smoke PM2.5 and lead to respiratory health improvements in elderly NA populations. Specific Aims are as follows: Aim 1. Facilitate the tribally-centered development, adaption, implementation, and evaluation of community-level wood yard and distribution programs for participating tribal households. Aim 2. Facilitate the development, adaptation, implementation, and evaluation of household-level education strategies targeting best-burn practices (Tx1) for each participating tribal community. Aim 3. Compare effectiveness, both within and between communities, of household-level interventions among elderly adults participating in a three-arm randomized placebo-controlled trial. Aim 3a. Compare group changes in pulmonary function and respiratory symptoms and infections. Aim 3b. Compare group changes in indoor and personal PM2.5 exposures. Aim 4. Evaluate penetration, acceptance, and sustainability of community- and household-level strategies using both qualitative and quantitative data generated in collaboration with tribal community advisory boards and research participants. Impact. The long-term goal of this project will be to reduce mortality and morbidity in NA communities from exposures related to residential home heating. This study will advance knowledge of effective interventions within two unique NA Reservations and describe improvements in sub-clinical indicators of pulmonary health in susceptible elderly populations. Reducing in-home wood smoke exposures through community level facilitation of access to proper fuels and introduction of sustainable, culturally appropriate best-burn practices will inform strategies for translation to other NA communities or similar rural and underserved populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory; Disorder, Functional, Impaired, Respiratory Infection Other

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education (Tx1)
Arm Type
Experimental
Arm Description
Education on best burn practices
Arm Title
Air Filtration Unit Treatment (Tx2)
Arm Type
Active Comparator
Arm Description
A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.
Arm Title
Placebo Intervention (Tx3)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education (Tx1)
Intervention Description
Education on best burn practices
Intervention Type
Device
Intervention Name(s)
Air Filtration Unit Treatment (Tx2)
Intervention Description
A 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove
Intervention Type
Device
Intervention Name(s)
Placebo Intervention (Tx3)
Intervention Description
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 Measure Information:
Title
Post-intervention FEV1
Description
Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters
Time Frame
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Title
Post-intervention FVC
Description
Mean of up to two post-intervention measures of forced vital capacity (FVC), liters
Time Frame
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Title
Post-intervention FEV1/FVC Ratio
Description
Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)
Time Frame
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Title
Post-intervention Systolic Blood Pressure
Description
Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)
Time Frame
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Title
Post-intervention Diastolic Blood Pressure
Description
Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)
Time Frame
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Health measures were collected at two visits during both winter periods with each visit separated by at least three weeks.
Secondary Outcome Measure Information:
Title
Post-intervention Indoor Fine Particulate Matter (PM2.5)
Description
Post-intervention average Indoor fine particulate matter (PM2.5) concentration
Time Frame
Each participant was followed during a pre-intervention baseline (Winter 1) and a post-intervention follow-up period (Winter 2). Indoor 48-hour PM2.5 average concentration was measured at two post-intervention visits separated by at least three weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis W Noonan, Ph.D.
Organizational Affiliation
University of Montana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annie Belcourt, Ph.D.
Organizational Affiliation
University of Montana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tony J Ward, Ph.D.
Organizational Affiliation
University of Montana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Montana
City
Missoula
State/Province
Montana
ZIP/Postal Code
59812
Country
United States

12. IPD Sharing Statement

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Wood Smoke Interventions in Native American Populations

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