CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 149 enrolled
Drug / intervention
Education (Tx1) +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02240069
NCT02240069N/ACompleted

Residential Wood Smoke Interventions Improving Health in Native American Populations

University of Montana·interventional·Posted Sep 15, 2014·Updated Dec 1, 2022

In Brief

A clinical study evaluating Education (Tx1), Air Filtration Unit Treatment (Tx2), and 1 other intervention for Respiratory; Disorder, Functional, Impaired and Respiratory Infection Other. Completed, enrolled 149 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 15, 2014
Enrollment StartNov 30, 2015
Primary CompletionJun 30, 2020
Study CompletionFeb 28, 2021
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 11.8 years ago

Interventions

Education (Tx1)behavioral

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.