Study protocol for a one-year, randomized, single-blind, clinical trial of stand-alone indoor air filtration in the homes of U.S. military Veterans with moderate to severe COPD in metropolitan Chicago

Author:

Stephens Brent1ORCID,Kang Insung2,Jagota Kaveeta3,Elfessi Zane3,Karpen Nancy4,Heidarinejad Mohammad1,Rubinstein Israel3

Affiliation:

1. Illinois Institute of Technology

2. The University of Texas at Arlington

3. Jesse Brown Veterans Affairs Medical Center

4. Department of Veterans Affairs: US Department of Veterans Affairs

Abstract

Abstract

Background Exposure to air pollutants is associated with adverse chronic obstructive pulmonary disease (COPD) outcomes. Although indoor air filtration can improve outcomes, few studies have investigated indoor air filtration for improving health-related outcomes in distinct patient populations with COPD.Methods This study seeks to evaluate the effectiveness of stand-alone air filtration for reducing residential indoor particulate matter concentrations and improving health-related outcomes in a high-risk urban cohort of U.S. military Veterans with COPD in metropolitan Chicago using a long-term (1-year), randomized, single-blind, placebo-controlled, case-control trial. Participants are randomized to receive a placebo/sham unit or a normally functioning filtration unit containing HEPA, activated carbon, and zeolite media. Low-cost sensors measure particulate matter concentrations and plug load data loggers measure air cleaner operation in each home throughout the study duration. The primary outcome is physician-diagnosed exacerbations of acute COPD over the study duration. Secondary outcomes include changes in health-related quality of life (HR-QoL), assessed at recruitment and after 12-months of intervention using the COPD-specific version of the St. George’s Respiratory Questionnaire (SGRQ-C) and Veterans RAND 36-Item Health Survey (VR-36), and clinical outcomes (e.g., emergency room and unscheduled medical visits, 6-minute walk distance (6MWD), oxygen saturation) assessed at baseline, endline, and throughout the study. Housing condition assessments are also conducted to characterize participant homes and housing-related factors that may contribute to COPD exacerbation or influence the effectiveness of the intervention. Our goal is to recruit 80 participants. The study population is expected to be predominantly African American, with a significant proportion living in historically underserved, low socioeconomic status neighborhoods.Discussion Outcomes from this pragmatic, real-world trial have the potential to inform policy and practice in both healthy housing and patient medical care by evaluating the impacts of long-term use of stand-alone portable air filtration in homes of high-risk COPD patients on indoor pollutant concentrations and COPD outcomes and providing novel data on associations between housing conditions and COPD outcomes in a high-risk cohort, as well as novel insight into air cleaner operation, in this vulnerable study population.Trial Registration: ClinicalTrials.gov: NCT05913765 (retrospectively registered, June 22, 2023)

Publisher

Springer Science and Business Media LLC

Reference50 articles.

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2. Trends in the Prevalence of Chronic Obstructive Pulmonary Disease Among Adults Aged ≥ 18 Years — United States, 2011–2021;Liu Y;MMWR Morb Mortal Wkly Rep,2023

3. Chronic obstructive pulmonary disease, hospital visits, and comorbidities: National Survey of Residential Care Facilities, 2010;Wheaton AG;J Aging Health,2015

4. Air pollution, lung function and COPD: results from the population-based UK Biobank study;Doiron D;Eur Respir J,2019

5. The National Human Activity Pattern Survey (NHAPS): a resource for assessing exposure to environmental pollutants;Klepeis NE;J Expo Anal Environ Epidemiol,2001

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