Air Filtration for COPD in VA Population of Veterans

Study Overview
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Brief Summary
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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. Additional 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
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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) 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 consumer-grade air quality sensors will be used to monitor for longer-term periods (i.e., in place 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.

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Air cleaner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 - 90+ years. English speaking and writing. Able to provide consent. Chicago resident. Veteran receiving health care at JBVAMC with a documented diagnosis of COPD. Stable housing for at least 6 months prior to screening. Able to communicate regularly by telephone. Documentation of full COVID-19 vaccination. Exclusion Criteria: Home palliative care. Life expectancy <6 months. Hazardous conditions and/or safety concerns in or around the veteran's household Screened patients that already have an air cleaner and alike in his/her current residence Concomitant operation of a non-study air cleaner and alike by a participant in his/her current residence at any time during the course of the trial constitutes protocol violation leading to disqualification of said participant from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, single-blind, placebo-controlled case-control design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>an air cleaner with HEPA and carbon filter installed | Device: Air cleaner<br>* Austin Air Healthmate air cleaner with or without standard filter<br>|
| Placebo Comparator: Placebo<br>an air cleaner with the primary filter removed | Device: Air cleaner<br>* Austin Air Healthmate air cleaner with or without standard filter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD exacerbations | Physician diagnosed exacerbation of acute COPD | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ED visits | Number of emergency room visits | Through study completion, an average of 1 year | 
| Urgent care visits | Number of urgent care visits | Through study completion, an average of 1 year | 
| Unscheduled clinic visits | Number of unscheduled clinic visits | Through study completion, an average of 1 year | 
| 6MWD | 6-minute walk distance | At the end of study completion, an average of 1 year | 
| O2 sat | Transcutaneous oxygen saturation at rest and during 6MWD | At the end of study completion, an average of 1 year | 
| Health related quality of life | Veterans Rand 36 Item Healthy Survey (VR 36) | At the end of study completion, an average of 1 year | 
| St. George's | St. George's Respiratory Questionnaire (SGRQ) score | At the end of study completion, an average of 1 year |