Kaiser Permanente Northern California Division of Research
Pleasanton, California, 94588, United States
NCT Number: NCT07118189
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.
This study is active but is not currently recruiting participants.
65 year and older
All sexes
Interventional
Not applicable
Pleasanton, California, 94588, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days
% of enrolled patients who complete all follow-up assessments
Time frame: 30 days
electrical sensors on the air cleaners showing the device was on for >80% of follow-up time
Time frame: Through study completion, an average of 18 months
how many patients were contacted to enroll 1 patient
Time frame: 30 days
air quality monitoring devices inside and outside the home, which record data internally when not connected to the internet
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
Time frame: 30 days
FEV1 improvement by portable spirometry
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
Time frame: 30 days
analysis of urinary F2-isoprostanes and Specific Gravity (SG)
Kaiser Permanente
Other
Acronym: DS-F
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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.
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