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| ID | Type | Description | Link |
|---|---|---|---|
| ILHHU0049-19 | Other Grant/Funding Number | US Department of Housing and Urban Development | |
| IRB #1675992 | Other Identifier | JBVAMC |
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| Name | Class |
|---|---|
| Jesse Brown VA Medical Center | FED |
| US Department of Housing and Urban Development | FED |
| Elevate | UNKNOWN |
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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. 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | an air cleaner with HEPA and carbon filter installed |
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| Placebo | Placebo Comparator | an air cleaner with the primary filter removed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air cleaner | Device | Austin Air Healthmate air cleaner with or without standard filter |
|
| Measure | Description | Time Frame |
|---|---|---|
| COPD exacerbations | Physician diagnosed exacerbation of acute COPD | Through study completion, an average of 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Israel Rubinstein, MD | Jesse Brown VA Medical Center | Principal Investigator |
| Mohammad Heidarinejad, PhD | Illinois Institute of Technology | Principal Investigator |
| Zane Elfessi, PharmD | Jesse Brown VA Medical Center | Principal Investigator |
| Kaveeta Jagota | Jesse Brown VA Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown Veterans Affairs Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40468409 | Derived | Stephens B, Kang I, Jagota K, Elfessi Z, Karpen N, Farhoodi S, Heidarinejad M, Rubinstein I. Study protocol for a 1-year, randomized, single-blind, parallel group trial of stand-alone indoor air filtration in the homes of US military Veterans with moderate to severe COPD in metropolitan Chicago. Trials. 2025 Jun 4;26(1):196. doi: 10.1186/s13063-025-08880-0. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Randomized, single-blind, placebo-controlled case-control design
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| 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |