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Active Not RecruitingNCT05913765

Air Filtration for COPD in VA Population of Veterans

Air Filtration to Improve Indoor Air Quality (IAQ) and Chronic Obstructive Pulmonary Disease (COPD) Outcomes in a High-risk Urban Population of U.S. Military Veterans

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Illinois Institute of Technology · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to investigate the effectiveness of stand-alone air filtration for improving indoor air quality (IAQ) and chronic obstructive pulmonary disease (COPD) outcomes in a high-risk urban cohort of 80 U.S. military veterans with COPD. Secondary goals of the study are to (1) investigate housing-related factors that may contribute to COPD exacerbation, (2) investigate the utility of using low-cost sensors for indoor air pollution epidemiology studies and for providing actionable or useful information on the quality of their indoor air to patients and their physicians, and (3) evaluate the costs and benefits of using stand-alone air filtration to improve IAQ and COPD outcomes.

Detailed description

The study will utilize a randomized, single-blind, placebo-controlled case-control design in which stand-alone portable air cleaners will be introduced to the study population over a period of approximately 1 year. One-half of the study population (40 participants) will receive a normally functioning filtration unit (i.e., an air cleaner with HEPA filter installed) and one-half of the study population (40 participants) will receive a placebo filtration unit (i.e., an air cleaner with the primary filter removed). The participants will be blinded; they will not know the status of the filter. Stand-alone portable air cleaning units containing HEPA filters and high clean air delivery rates (CADRs) sufficiently sized for the spaces they will serve will be used. The study will also involve housing condition assessments conducted in each home to characterize housing-related factors that may contribute to COPD exacerbation at baseline, as well as measurements of indoor and outdoor air quality and environmental conditions, and records of clinical outcomes (e.g., COPD exacerbations, emergency room visits, 6-minute walk distance, oxygen saturation, etc. accessed through the subject's VA medical record) throughout the study duration. The validated and extensively used St. George's Respiratory Questionnaire (SGRQ-C) and Veterans RAND 36-Item Health Survey (VR-36) will be used to determine health-related quality of life (HR-QoL) of participants by the JBVAMC Study Personnel. Clinical outcomes will also be used to assess costs of care with and without filtration interventions in this population. Low-cost air quality sensors will be used to monitor IAQ for the duration of the study). The study will also evaluate the upfront costs and operational and maintenance costs of the air cleaners over the course of the intervention periods and will compare them to the expected impacts on costs of care both with and without filtration interventions in this population.

Conditions

Interventions

TypeNameDescription
DEVICEAir cleanerAustin Air Healthmate air cleaner with or without standard filter

Timeline

Start date
2023-01-11
Primary completion
2025-10-01
Completion
2025-12-31
First posted
2023-06-22
Last updated
2024-10-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05913765. Inclusion in this directory is not an endorsement.

Air Filtration for COPD in VA Population of Veterans (NCT05913765) · Clinical Trials Directory