Clinical trial NCT05913765: Air Filtration for COPD in VA Population of Veterans
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Illinois Institute of Technology
Sponsor class: OTHER
Collaborators: name: Jesse Brown VA Medical Center
name: US Department of Housing and Urban Development
name: Elevate
First posted: 2023-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blind, placebo-controlled case-control design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: COPD exacerbations
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: ED visits
timeFrame: Through study completion, an average of 1 year
measure: Urgent care visits
timeFrame: Through study completion, an average of 1 year
measure: Unscheduled clinic visits
timeFrame: Through study completion, an average of 1 year
measure: 6MWD
timeFrame: At the end of study completion, an average of 1 year
measure: O2 sat
timeFrame: At the end of study completion, an average of 1 year
measure: Health related quality of life
timeFrame: At the end of study completion, an average of 1 year
measure: St. George's
timeFrame: At the end of study completion, an average of 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown Veterans Affairs Medical Center
state: Illinois
Study officials:
affiliation: Jesse Brown VA Medical Center
name: Israel Rubinstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Illinois Institute of Technology
name: Mohammad Heidarinejad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jesse Brown VA Medical Center
name: Zane Elfessi, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jesse Brown VA Medical Center
name: Kaveeta Jagota
role: STUDY_DIRECTOR
References: