Air Filtration for COPD in VA Population of Veterans
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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) 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention an air cleaner with HEPA and carbon filter installed |
Device: Air cleaner
Austin Air Healthmate air cleaner with or without standard filter
|
| Placebo Comparator: Placebo an air cleaner with the primary filter removed |
Device: Air cleaner
Austin Air Healthmate air cleaner with or without standard filter
|
Outcome Measures
Primary Outcome Measures
- COPD exacerbations [Through study completion, an average of 1 year]
Physician diagnosed exacerbation of acute COPD
Secondary Outcome Measures
- ED visits [Through study completion, an average of 1 year]
Number of emergency room visits
- Urgent care visits [Through study completion, an average of 1 year]
Number of urgent care visits
- Unscheduled clinic visits [Through study completion, an average of 1 year]
Number of unscheduled clinic visits
- 6MWD [At the end of study completion, an average of 1 year]
6-minute walk distance
- O2 sat [At the end of study completion, an average of 1 year]
Transcutaneous oxygen saturation at rest and during 6MWD
- Health related quality of life [At the end of study completion, an average of 1 year]
Veterans Rand 36 Item Healthy Survey (VR 36)
- St. George's [At the end of study completion, an average of 1 year]
St. George's Respiratory Questionnaire (SGRQ) score
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jesse Brown Veterans Affairs Medical Center | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- Illinois Institute of Technology
- Jesse Brown VA Medical Center
- US Department of Housing and Urban Development
- Elevate
Investigators
- Principal Investigator: 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
- Study Director: Kaveeta Jagota, Jesse Brown VA Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- irb-2022-92
- ILHHU0049-19
- IRB #1675992