- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02240069
Wood Smoke Interventions in Native American Populations (EldersAIR)
Residential Wood Smoke Interventions Improving Health in Native American Populations
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Montana
-
Missoula, Montana, United States, 59812
- University of Montana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education (Tx1)
Education on best burn practices
|
Education on best burn practices
|
Active Comparator: Air Filtration Unit Treatment (Tx2)
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 (3M, St. Paul, MN) will be placed in the same room as the wood stove
|
Sham Comparator: Placebo Intervention (Tx3)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1), liters
|
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.
|
Post-intervention 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.
|
Mean of up to two post-intervention measures of forced vital capacity (FVC), liters
|
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.
|
Post-intervention FEV1/FVC Ratio
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.
|
Mean of up to two post-intervention measures of forced expiratory volume at one second (FEV1) / forced vital capacity (FVC)
|
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.
|
Post-intervention Systolic Blood Pressure
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.
|
Mean of up to two post-intervention measures of systolic blood pressure, millimeters of mercury (mmHg)
|
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.
|
Post-intervention Diastolic Blood Pressure
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.
|
Mean of up to two post-intervention measures of diastolic blood pressure, millimeters of mercury (mmHg)
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-intervention Indoor Fine Particulate Matter (PM2.5)
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.
|
Post-intervention average Indoor fine particulate matter (PM2.5)
concentration
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Curtis W Noonan, Ph.D., University of Montana
- Principal Investigator: Tony J Ward, Ph.D., University of Montana
- Principal Investigator: Annie Belcourt, Ph.D., University of Montana
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 218-12
- R01ES022583 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Infection Other
-
Hospital Universitari Joan XXIII de Tarragona.TerminatedVentilator Associated Pneumonia | Prevention | Respiratory Infection OtherSpain
-
Adapt Produtos Oftalmológicos Ltda.UnknownEye Infection/Inflammation OtherBrazil
-
Vedic Lifesciences Pvt. Ltd.Completed
-
University of MontanaNational Institute of Environmental Health Sciences (NIEHS)CompletedLower Tract Respiratory InfectionUnited States
-
SciensanoJessa Hospital; Universitair Ziekenhuis Brussel; AZ Sint-Jan AV; Centre Hospitalier... and other collaboratorsCompletedInfluenza Viral Infections | Respiratory Viral Infection | Severe Acute Respiratory Infection
-
European Clinical Research Alliance for Infectious...UMC Utrecht; University of OxfordNot yet recruitingAcute Respiratory Infection | Acute Respiratory Tract Infection
-
ProMedica Health SystemCompletedOther Specified Respiratory Problems in Fetus or NeonateUnited States
-
NPO PetrovaxCompletedAcute Respiratory InfectionRussian Federation
-
Materia Medica HoldingCompletedViral Respiratory Infection
-
Reckitt Benckiser LLCCompletedAcute Respiratory InfectionUnited States
Clinical Trials on Education (Tx1)
-
University of MontanaNational Institute of Environmental Health Sciences (NIEHS)CompletedLower Tract Respiratory InfectionUnited States
-
Real Centro Universitario Maria CristinaUniversité du Québec à Trois-Rivières; University of BirminghamCompletedMusculoskeletal Pain | Psychological Distress | Disability PhysicalSpain
-
Erzincan UniversityCompletedQuality of Life | Nursing Caries | Breastfeeding | Postpartum | Nursing Model | Levine Conservation Model
-
Oregon Health and Science UniversityEnrolling by invitation
-
Mexican National Institute of Public HealthUniversity of North Carolina, Chapel Hill; Danone ResearchCompleted
-
University of Social Sciences and Humanities, WarsawNational Science Centre, PolandRecruiting
-
Pamukkale UniversityCompletedBreastfeeding | ImmigrantTurkey
-
University of MostarUnknownPain Score | Apgar Score | Mental Health Issue | Delivery Mode | Breastfeeding RateBosnia and Herzegovina
-
Centro de Endocrinologia Experimental y AplicadaNational Council of Scientific and Technical Research, ArgentinaCompletedType 2 DiabetesArgentina
-
US Department of Veterans AffairsThe American Legion Department of WisconsinCompletedCoronary Artery Disease | Hypertension | Diabetes Mellitus | HyperlipidemiaUnited States