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

NCT07118189 | Enrolling By Invitation

• 1 other identifier: 2293325
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Exacerbation of COPD; Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease (COPD); air pollution; wildfire smoke

Outcome Measures

Primary Outcomes (2)

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

  % of enrolled patients who complete all follow-up assessments

  30 days

• fidelity

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

  30 days

Secondary Outcomes (6)

• average screen-to-enrollment ratio

  Through study completion, an average of 18 months

• indoor and outdoor PM2.5 concentrations

  30 days

• respiratory quality of life

  30 days

• effectiveness

  30 days

• acceptability

  30 days

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Device: N95 masks and indoor air cleaner

Control

NO INTERVENTION

Both intervention and control arms will receive education.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northern California Division of Research

Pleasanton, California, 94588, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

N95 Respirators

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Respiratory Protective Devices; Personal Protective Equipment; Protective Devices; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: data analysts
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized in-home intervention pilot trial

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)