Pulmonary Disease, Chronic Obstructive
Conditions
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. 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.
Interventions
DEVICEAir cleaner
Austin Air Healthmate air cleaner with or without standard filter
Sponsors
Jesse Brown VA Medical Center
US Department of Housing and Urban Development
Elevate
Illinois Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized, single-blind, placebo-controlled case-control design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: 18 - 90+ years. 2. English speaking and writing. 3. Able to provide consent. 4. Resident of Chicago metropolitan area. 5. Veteran receiving health care at JBVAMC with a documented diagnosis of COPD. 6. Stable housing for at least 6 months prior to screening. 7. Able to communicate regularly by telephone.
Exclusion criteria
1. Home palliative care. 2. Life expectancy \<6 months. 3. Hazardous conditions and/or safety concerns in or around the veteran's household 4. Screened patients that already have an air cleaner and alike in his/her current residence 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD exacerbations | Through study completion, an average of 1 year | Physician diagnosed exacerbation of acute COPD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| ED visits | Through study completion, an average of 1 year | Number of emergency room visits |
| 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 |
| O2 sat | At the end of study completion, an average of 1 year | Transcutaneous oxygen saturation at rest and during 6MWD |
Countries
United States
Outcome results
None listed