AzTrials
AzTrials

Respiratory; Disorder, Functional, ImpairedEldersAIRNCT02240069

Wood Smoke Interventions in Native American Populations

A study testing Education (Tx1) and Air Filtration Unit Treatment (Tx2) in people with Respiratory; Disorder, Functional, Impaired and Respiratory Infection Other, run by University of Montana at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
What is being tested?
Education (Tx1) and Air Filtration Unit Treatment (Tx2)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
149 participants
Where
1 siteUnited States
Study dates
30 Nov 2015to 28 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Montana

    Missoula, Montana, 59812

Other trials in United States

About this study

Official title: Residential Wood Smoke Interventions Improving Health in Native American Populations

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.

Read the 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.

Being tested
Education (Tx1), Air Filtration Unit Treatment (Tx2), Placebo Intervention (Tx3)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education (Tx1)Behavioural

    Education on best burn practices

  • Air Filtration Unit Treatment (Tx2)Device

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

  • Placebo Intervention (Tx3)Device

    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.

Study groups in NCT02240069
Study groupRoleWhat they receive
Education (Tx1)ExperimentalEducation on best burn practices
Receives: Behavioral: Education (Tx1)
Air Filtration Unit Treatment (Tx2)Active comparatorA 20" x 18" Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove.
Receives: Device: Air Filtration Unit Treatment (Tx2)
Placebo Intervention (Tx3)Sham comparatorA 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.
Receives: Device: Placebo Intervention (Tx3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-intervention FEV1

    Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters

    Measured: 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.

  2. Post-intervention FVC

    Mean of up to two post-intervention measures of forced vital capacity (FVC), liters

    Measured: 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.

  3. 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)

    Measured: 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.

  4. Post-intervention Systolic Blood Pressure

    Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)

    Measured: 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.

  5. Post-intervention Diastolic Blood Pressure

    Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)

    Measured: 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 outcomes (1)
  1. Post-intervention Indoor Fine Particulate Matter (PM2.5)

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2014 (estimated)
  2. Study start30 Nov 2015
  3. Primary completion30 Jun 2020
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240069
Sponsor's protocol ID
IRB 218-12
Other IDs
R01ES022583
Acronym
EldersAIR
Status last verified
Nov 2022
First submitted
10 Sep 2014
Last updated
1 Dec 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Education (Tx1) and Air Filtration Unit Treatment (Tx2) in people with Respiratory; Disorder, Functional, Impaired and Respiratory Infection Other, run by University of Montana at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-intervention FEV1 (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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in