Evaluation of a Novel Indoor Air Pollution Intervention Among Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Predicting Risk of CVD EVENTs (PREVENT) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 79 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55-79 years of age one primary residence (5+ days per week)
- •have an electronic device, email address, and reliable internet at home for survey submission
排除标准
- •current smoking of any kind or living in a household with someone who currently smokes
- •current use of a portable air cleaner unit at home
- •plans to move in the next year
- •previous physician-diagnosed cardiovascular disease (coronary heart disease [myocardial infarction], stroke, or heart failure)
研究组 & 干预措施
AIRWISE Intervention
Participants randomized to the AIRWISE Intervention group will use AIRWISE in their homes for 12 months. The AIRWISE group will use two PACs to filter indoor air and two optical PM2.5 sensors with lights that change color in real time according to AQI. In addition, automated outdoor air quality alerts are sent via text and email when outdoor AQI goes above 75 (mid-point of the Moderate AQI category). Outdoor air quality will be referenced from the Environmental Protection Agency or PurpleAir monitor nearest to the participant's home. Based on the indoor and outdoor AQI levels, participants will reference a decision matrix and educational materials to make informed decisions on improving indoor air quality. Education and behavioral strategies are delivered through multiple approaches, including visual aids, handouts, videos, and a magnet with the decision matrix that can be placed in an accessible location in the home.
干预措施: Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE) (Behavioral)
PAC Control
Participants randomized to the PAC Control group will use two PACs in their home without additional AIRWISE equipment/education. After randomization, they will be given instructions on study procedures and using the PAC units 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. They will receive PurpleAir sensors without an AQI light that are for data collection purposes only, and they will not have access to the data throughout the study. Control participants will use and maintain the PACs at their own discretion. At the end of their participation, they will have the option of receiving the additional AIRWISE components.
干预措施: Portable Air Cleaner (PAC) Control (Other)
结局指标
主要结局
Predicting Risk of CVD EVENTs (PREVENT) Score
时间窗: 0, 6, 12 months
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.
次要结局
- Uric acid(0, 6, 12 months)
- CBC(0, 6, 12 months)
- Life's Essential 8 (LE8) Score(0, 6, 12 months)
- Indoor PM2.5(Continuous at 2-minute intervals)
- Indoor VOCs(Continuous at 2-minute intervals)
- Glycated hemoglobin(0, 6, 12 months)
- Estimated Glomerular Filtration Rate(0, 6, 12 months)
- Total cholesterol(0, 6, 12 months)
- HDL cholesterol(0, 6, 12 months)
- LDL cholesterol(0, 6, 12 months)
- CRP(0, 6, 12 months)
- ESR(0, 6, 12 months)
- Systolic and diastolic blood pressure(Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.)
- Health symptoms(Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.)
- Physical activity(Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.)
- Sleep quality(Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.)
- Diet(Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.)
- BMI(Baseline)
