Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02240069 |
| Other study ID # |
IRB 218-12 |
| Secondary ID |
R01ES022583 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2015 |
| Est. completion date |
February 28, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
University of Montana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
