Evaluation of a Novel Indoor Air Pollution Intervention Among Older Adults
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), Portable Air Cleaner (PAC) Control.
- Кому может быть актуально
- Состояния в реестре: Cardiovascular Diseases, Blood Pressure, Glycated Hemoglobin (HbA1c), Cholesterol. Базовые параметры: 55 лет — 79 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE)
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 ai - Другое Portable Air Cleaner (PAC) Control
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.
Первичные конечные точки
- Predicting Risk of CVD EVENTs (PREVENT) Score [Срок оценки: 0, 6, 12 months]
Вторичные конечные точки (12)
- Life's Essential 8 (LE8) Score [Срок оценки: 0, 6, 12 months]
- Indoor PM2.5 [Срок оценки: Continuous at 2-minute intervals]
- Indoor VOCs [Срок оценки: Continuous at 2-minute intervals]
- Glycated hemoglobin [Срок оценки: 0, 6, 12 months]
- Estimated Glomerular Filtration Rate [Срок оценки: 0, 6, 12 months]
- Total cholesterol [Срок оценки: 0, 6, 12 months]
- HDL cholesterol [Срок оценки: 0, 6, 12 months]
- LDL cholesterol [Срок оценки: 0, 6, 12 months]
- CRP [Срок оценки: 0, 6, 12 months]
- ESR [Срок оценки: 0, 6, 12 months]
- Uric acid [Срок оценки: 0, 6, 12 months]
- CBC [Срок оценки: 0, 6, 12 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- University of Montana — Missoula
Идентификаторы
NCT: NCT07539987 · 25-0467