Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07118189

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California Division of Research

Pleasanton, California, 94588, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N95 masks and indoor air cleaner

Device

Participants who are randomized into the intervention will receive N95 masks to be worn outdoors and an indoor air cleaner in the room that the participant spends the most time in their home. Both intervention and control arms will receive education.

Primary outcomes

  1. feasibility (by percent of enrolled patients who complete all follow-up assessments)

    Time frame: 30 days

    % of enrolled patients who complete all follow-up assessments

  2. fidelity

    Time frame: 30 days

    electrical sensors on the air cleaners showing the device was on for >80% of follow-up time

Secondary outcomes

  1. average screen-to-enrollment ratio

    Time frame: Through study completion, an average of 18 months

    how many patients were contacted to enroll 1 patient

  2. indoor and outdoor PM2.5 concentrations

    Time frame: 30 days

    air quality monitoring devices inside and outside the home, which record data internally when not connected to the internet

  3. respiratory quality of life

    Time frame: 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

  4. effectiveness

    Time frame: 30 days

    FEV1 improvement by portable spirometry

  5. acceptability

    Time frame: 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

  6. Urine oxidative stress

    Time frame: 30 days

    analysis of urinary F2-isoprostanes and Specific Gravity (SG)

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Acronym: DS-F

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.