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COMPLETED NA

Wood Smoke Interventions in Native American Populations

NCT02240069 · View on ClinicalTrials.gov ↗

Study 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 population

Interventions

  • DEVICE Air Filtration Unit Treatment (Tx2)
  • DEVICE Placebo Intervention (Tx3)
  • BEHAVIORAL Education (Tx1)

Study Locations (1)

Montana

  • University of Montana — Missoula

Trial Details

FieldValue
Enrollment Target 149 participants
Start Date 2015-11-30
Est. Completion 2021-02-28
Phase NA

Sponsor

University of Montana

42 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02240069

The ClinicalTrials.gov registry entry for NCT02240069 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Montana, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Respiratory; Disorder, Functional, Impaired appearing as the primary indexed condition, and to 3 interventions — of which Air Filtration Unit Treatment (Tx2) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02240069 reports 1 study location spanning 1 distinct geographic area — top geographies include Montana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02240069 about?

NCT02240069 is a clinical study titled "Wood Smoke Interventions 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 di...

What is the current status of trial NCT02240069?

This trial is currently completed. It is a NA study. The enrollment target is 149 participants. The study started on 2015-11-30. Estimated completion is 2021-02-28.

What conditions does trial NCT02240069 study?

This clinical trial studies the following conditions: Respiratory; Disorder, Functional, Impaired, Respiratory Infection Other. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02240069?

The interventions under investigation include: Air Filtration Unit Treatment (Tx2) (DEVICE), Placebo Intervention (Tx3) (DEVICE), Education (Tx1) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02240069?

This trial is sponsored by University of Montana, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02240069 being conducted?

This trial has 1 study location across Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial