跳至主要内容
临床试验/NCT02240069
NCT02240069已完成不适用

Residential Wood Smoke Interventions Improving Health in Native American Populations

University of Montana2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2015年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
2
主要终点
Post-intervention FVC

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 未提供

结局指标

主要结局

Post-intervention FVC

时间窗: 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.

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

Post-intervention FEV1

时间窗: 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.

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

Post-intervention Diastolic Blood Pressure

时间窗: 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.

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

Post-intervention FEV1/FVC Ratio

时间窗: 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.

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

时间窗: 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.

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

次要结局

  • Post-intervention Indoor Fine Particulate Matter (PM2.5)(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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Curtis Noonan

Principal Investigator, Professor

University of Montana

研究点 (2)

Loading locations...

相似试验

Wood Smoke Interventions in Native American... | 临床试验