Laying the Foundation for Building a Resilient KPNC Community in the Face of Worsening Air Quality Due to Wildfire Smoke

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Exacerbation of COPD; Exacerbation of Chronic Obstructive Pulmonary Disease

• Registration Number: NCT07118189
• Lead Sponsor: Kaiser Permanente

Brief Summary

The overarching goal of this project is to conduct a pilot intervention in high-risk Kaiser Permanente Northern California patients with chronic obstructive pulmonary disease to mitigate their exposure to poor air quality and decrease exacerbations of lung disease.

Detailed Description

Over the past decade, the frequency and impact of wildfires has steadily worsened across California, a trend that is expected to continue as climate change becomes an urgent, everyday reality. This means that the number of Kaiser Permanente Northern California (KPNC) members exposed to unhealthy air quality due to wildfire smoke will increase dramatically. Unsurprisingly, vulnerable patients are disproportionately impacted, such as those with chronic obstructive pulmonary disease (COPD). In this rigorous pilot, we will deploy a pilot in-home intervention to non-smoking, oxygen-dependent patients who have frequent exacerbations of COPD to mitigate their exposure to poor air quality and reduce exacerbations.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-05
• Study First Posted: 2025-08-12
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-17
• Study Start: 2025-09-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• KPNC patients
• enrolled in Care Plus
• non-smoking
• oxygen-dependent
• adults aged ≥65 years old
• have had membership for at least 1 year prior to data extraction not counting </=3mo gaps)
• have known COPD (at least 2 encounters with COPD ICD codes over a 3 year period in the 10 years prior to data extraction using the following ICD codes: ICD-9 491.21, 491.22, 491.8, 491.9, 492.8, 493.2, 493.21, 493.22, 496 and ICD-10 J44.1, J44.0, J41.8, J44.9, J42)15
• have picked up at least 1 controller inhaler at the pharmacy within 1 year prior to data extraction
• at least 2 exacerbations of COPD treated in any setting (outpatient or acute care) within 1 year before to data extraction.

Exclusion Criteria

• with <1 year of continuous membership prior to the date they entered the cohort, allowing for 3-month, non-contiguous gaps
• any diagnosis with any of the past or present problems: blindness, dementia, deaf or hearing impaired, hospice admission, "tracheostomy" procedure code or problems and/or attached to a ventilator
• hearing, visually, physically, memory, and/or speech impaired
• those on the "Do Not Call" list
• non-English speakers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
feasibility (by percent of enrolled patients who complete all follow-up assessments)	30 days	% of enrolled patients who complete all follow-up assessments
fidelity	30 days	electrical sensors on the air cleaners showing the device was on for \>80% of follow-up time

Secondary Outcome Measures

Name	Time	Method
average screen-to-enrollment ratio	Through study completion, an average of 18 months	how many patients were contacted to enroll 1 patient
indoor and outdoor PM2.5 concentrations	30 days	air quality monitoring devices inside and outside the home, which record data internally when not connected to the internet
respiratory quality of life	30 days	via St George's respiratory questionnaire for COPD - Part 1 : Symptoms component (frequency \& severity) with a 1-month recall; Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall (dichotomous (true/false) except last question (4-point Likert scale)); Scores range from 0 to 100, with higher scores indicating more limitations
effectiveness	30 days	FEV1 improvement by portable spirometry
acceptability	30 days	\>90% reporting satisfied/very satisfied on 5-point Likert scale as well as in qualitative interviews for feedback about the intervention, specifically which aspect of the intervention was most/least helpful and most/least burdensome, including aspects that should be changed to increase participation in future trials
Urine oxidative stress	30 days	analysis of urinary F2-isoprostanes and Specific Gravity (SG)

Trial Locations

Locations (1)

Kaiser Permanente Northern California Division of Research; 🇺🇸 Pleasanton, California, United States