Particulate matter air pollution is the leading environmental risk factor of cardiovascular disease and is increasing in the Western United States due to more frequent and severe wildfires. Older adults are particularly susceptible to both air pollution exposures and the development of cardiovascular disease, and the older adult population in the United States is rapidly growing. Given the converging threats of worsening air quality and an aging population, this clinical trial will evaluate a novel, multifaceted indoor air quality intervention to improve cardiovascular health outcomes among older adults in the wildfire-impacted state of Montana.
Particulate matter (PM) air pollution is the leading risk factor of global disease burden and the largest environmental risk factor for premature death and cardiovascular disease (CVD). Older adults are particularly susceptible to air pollution exposures and the development of CVD as they often have underlying health conditions. PM levels are rising in the Western United States (US) as wildfires have increased, with up to 50% of fine PM (PM2.5; particles \<2.5 µm in diameter) in some Western regions now attributed to wildfires. Recent research indicates there is often a substantial increase in indoor PM2.5 when outdoor PM2.5 increases, including during wildfire events. Improving indoor air quality is critically important as US adults spend 90% of their time indoors where air quality is impacted by numerous indoor and outdoor air pollution sources. New strategies are needed to improve indoor air quality and CVD health outcomes, particularly as the US population rapidly ages and the number of susceptible older adults grows. There is evidence that filtering indoor air with portable air cleaners (PACs) can result in short-term PM2.5 improvements. However, evidence is limited that PAC use meaningfully improves health, particularly in studies of longer duration. In response to this need, the investigators have developed a household indoor air quality intervention called AIRWISE (Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education). AIRWISE promotes sustained improvements in indoor air quality through education, behavioral cues, and equipment including PACs and PM2.5 sensors that display real-time data. In this project, the investigators will evaluate the AIRWISE intervention among older adults in the wildfire-impacted US state of Montana. In Aim 1, the investigators will conduct a randomized trial to test the efficacy of the AIRWISE intervention on PREVENT (Predicting Risk of CVD EVENTs), a validated CVD risk score. The central hypothesis is that PREVENT will be improved among older adults who use AIRWISE compared to controls who use only PACs. The rationale is that the AIRWISE intervention will promote sustained improvements in indoor air quality and CVD risk, a significant advance beyond PACs alone that are widely recommended yet have inconsistent benefits on long-term health. In Aim 2, the investigators will use Aim 1 data to determine associations between indoor PM2.5 concentrations and PREVENT. The investigators will use additional models between PM2.5 and the individual components of PREVENT as outcomes in order to determine which risk factors are most impacted by PM2.5 and inform underlying subclinical mechanisms. In Aim 3, the investigators will model the economic costs and benefits of indoor PM2.5 improvements and the AIRWISE intervention to inform policy-level action. With the converging threats of increasing air pollution due to wildfires and an aging US population, this project will contribute to identifying actionable strategies to improve indoor air quality and decrease CVD risk among older adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
154
The AIRWISE intervention consists of a 3-pronged approach grounded in the Health Belief Model (HBM) to improve residential indoor air quality through education, equipment, and behavioral cues. To reinforce cues to action, AIRWISE uses alerts from air quality sensors, prompting timely behavioral responses. Specifically, indoor and outdoor air quality alerts act as behavioral cues to promote active engagement and reference a decision matrix with specific recommendations based indoor and outdoor air quality. Recommendations on the decision matrix include simple strategies to reduce air pollution exposures, including increasing use and fan speed of portable air cleaners, opening or closing windows to change ventilation, and changing activities such as physical activity, cooking, and cleaning. This integrated approach promotes sustained behavior change by aligning with all key HBM constructs.
Participants will use two PACs in their home according to manufacturer recommendations. PAC Control group participants will not receive further education on air quality or recommendations on PAC use, nor will they receive additional equipment or outdoor AQI alerts. Control participants will use and maintain the PACs at their own discretion.
University of Montana
Missoula, Montana, United States
Predicting Risk of CVD EVENTs (PREVENT) Score
Validated cardiovascular disease (CVD) risk score called Predicting Risk of CVD EVENTs (PREVENT). The score is a percentage ranging from 0 to 100 that indicates percentage risk of developing CVD, with higher scores indicating higher risk of developing CVD.
Time frame: 0, 6, 12 months
Life's Essential 8 (LE8) Score
Validated metric of cardiovascular health called Life's Essential 8 (LE8). The score ranges from 0 to 100, with higher scores indicating better cardiovascular health and lower risk of adverse cardiovascular outcomes.
Time frame: 0, 6, 12 months
Indoor PM2.5
Fine particulate matter (PM2.5), or particles that are less than 2.5 micrometers in aerodynamic diameter and a primary component of air pollution
Time frame: Continuous at 2-minute intervals
Indoor VOCs
Volatile Organic Compounds (VOCs), a component of air pollution
Time frame: Continuous at 2-minute intervals
Glycated hemoglobin
A measure of blood sugar levels measured through venous blood draw and used to calculate the primary PREVENT outcome
Time frame: 0, 6, 12 months
Estimated Glomerular Filtration Rate
A measure of kidney function measured through venous blood draw and used to calculate the primary PREVENT outcome
Time frame: 0, 6, 12 months
Total cholesterol
Measured through venous blood draw and used to calculate the primary PREVENT outcome
Time frame: 0, 6, 12 months
HDL cholesterol
High-density lipoprotein cholesterol measured through venous blood draw and used to calculate the primary PREVENT outcome
Time frame: 0, 6, 12 months
LDL cholesterol
Low-density lipoprotein cholesterol measured through venous blood draw and used to calculate the primary PREVENT outcome
Time frame: 0, 6, 12 months
CRP
C-reactive protein, a measure of inflammation measured through venous blood draw
Time frame: 0, 6, 12 months
ESR
Erythrocyte sedimentation rate, used as a measure of inflammation measured through venous blood draw
Time frame: 0, 6, 12 months
Uric acid
Used as a measure of inflammation measured through venous blood draw
Time frame: 0, 6, 12 months
CBC
Used as a measure of inflammation measured through venous blood draw
Time frame: 0, 6, 12 months
Systolic and diastolic blood pressure
A risk factor for CVD and used to calculate the primary PREVENT outcome
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Health symptoms
Health symptoms will be reported in a questionnaire and used as a measure of quality of life. The questionnaire includes 6 questions and asks about recent illness and frequency of symptoms including eye irritation, blurred vision, wheezing, cough, throat irritation, difficulty breathing, excessive mucus, nose irritation, and headache.
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Physical activity
A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome. Physical activity will be reported in a questionnaire. The questionnaire includes 12 questions and asks about type, duration, and location of recent physical activities.
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Sleep quality
A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome. Sleep quality will be reported in a questionnaire. The questionnaire includes 9 questions and asks about duration, quality, barriers, and facilitators of sleep over the previous month.
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Diet
A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome. Diet will be reported in a questionnaire. The questionnaire includes 16 questions and asks about the recent frequency and amount of consuming 16 different types of foods.
Time frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
BMI
A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome
Time frame: Baseline
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