Mountain West Hub: Building Resilience to Address Health Impacts of Air Quality in Rural and Urban Communities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 550
- 主要终点
- Indoor Air Quality
研究概览
简要总结
Elevated levels of particulate matter (PM) are associated with adverse health outcomes such as asthma exacerbations, cardiovascular issues, and respiratory diseases. This study focuses on air quality (AQ) exposures in rural and urban communities in Colorado's San Luis Valley (SLV) and West Denver (WD). This study will use an effectiveness-implementation study using a randomized stepped wedge study design to test a technological and behavioral intervention aimed at mitigating exposure to PM. Specifically, this study will test the effectiveness and implementation of air cleaners when deployed in low-resource rural and urban communities. It will address three aims: 1) Evaluate impacts of intervention on air cleaner adoption, use; 2) Evaluate impacts of air cleaners on exposure to indoor PM associated with ambient PM due to climate stressors; and 3) Evaluate impacts of air cleaners on health outcomes and biomarkers of exposures.
详细描述
Our Phase II project is designed using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and PRISM (Practical, Robust, Implementation, Sustainability, and Monitoring) frameworks to evaluate each stage of the implementation process. RE-AIM will assess reach and effectiveness, as well as measures of implementation and sustainability. PRISM will aid in design and sustainability, as we seek to better understand and incorporate community perspectives and factors related to the external environment and implementation and sustainability infrastructure. This holistic view of implementation will inform sustainability and scalability to other communities.
Hybrid Type 1 Effectiveness-Implementation Study: Household Do it Yourself Air Cleaner (DIYac) Intervention While there is abundant evidence on the efficacy of a DIYac in reducing particulate matter (PM) in well-controlled environments, there is a lack of data on their effectiveness when deployed in real world settings. A Hybrid Type 1 (HT1) design is thus appropriate for our study, which tests the effectiveness of DIYac when implemented in rural and urban low-resource populations (WD and SLV). Effectiveness outcomes include behaviors (DIYac correct use), air quality (measured as PM), and physical and mental health indicators. Following HT1 design principles, we will integrate a process evaluation, guided by the RE-AIM and PRISM frameworks, to identify barriers and facilitators to broader, scalable implementation of the intervention as PM exposure mitigation strategy.
Stepped Wedge Design We will recruit and enroll a total of 550 households (WD: n=300; SLV: n=250) using a stratified random selection from an enumerated address for both communities derived from publicly available tax parcel mailing lists. Addresses will be stratified by county (SLV) and neighborhood (WD) to ensure geographic representation for the sample in each community. After selection, households within each community will be randomly assigned to two groups which determine at what point in the study the intervention is initiated. Given the high prevalence of related health outcomes (e.g. asthma, chronic obstructive pulmonary disease (COPD)), we anticipate that a random sample from each stratum will include key groups (outdoor workers (20-60%), chronic diseases (12%), aging (30%), and household with children (30%)).
Natural Experiment Readiness Our project is designed to facilitate a rapid response to an event, such as a wildfire or dust storm, by employing a flexible and adaptive framework that can quickly mobilize resources and data collection efforts. Previous work by research team members demonstrates our adaptability to launch responsive, multidisciplinary research following events; we are well-equipped to apply similar approaches to assess the effectiveness of DIYac in mitigating exposure to elevated PM inside homes. By using a natural experiment design, the research can compare households with and without DIYac interventions and track emergent and urgent care trends, offering crucial insights into the potential for widespread implementation of these systems in at-risk regions.
Study Aims & Research Questions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resides in the San Luis Valley or West Denver areas of Colorado
- •Live in their home at least 9 months of the year
- •At least 7 years old
排除标准
- •Owns an air cleaner
- •Does not speak Spanish or English
研究组 & 干预措施
Early Implementation
Early implementation arm will receive the intervention early in the study, immediately following a 3 month baseline period
干预措施: DIY Air Cleaner and Breathe Clean Video (Behavioral)
Delayed Implementation
Delayed implementation arm will also receive the intervention, 9 months after the early implementation arm.
干预措施: DIY Air Cleaner and Breathe Clean Video (Behavioral)
结局指标
主要结局
Indoor Air Quality
时间窗: From baseline home visit to endpoint home visit (24 months later), measured continuously.
Continuous PM2.5 concentration in room where DIYaf is located
Air Quality and Health Impacts Knowledge
时间窗: Measured at baseline and 24 months later at endpoint
Knowledge about air quality and related health impacts. Measured by 4 newly developed survey items with a yes/no scale that will be aggregated to one knowledge score. The minimum total score is 0, maximum 4 with a higher score related to higher knowledge.
Air Quality and Health Perspectives
时间窗: Measured at baseline and endpoint (24 months later)
Perspectives about the impact of air quality on health. Measured by 4 survey items utilizing a 5 point likert scale. A total score will be calculated for overall perceptions. The minimum score is 5 and the maximum score is 20, with higher scores related to more accurate perspectives.
DIY Air Cleaner Adoption
时间窗: Measured at quarterly home visits from baseline to endpoint (24 months after baseline)
Whether DIY air cleaner is placed in house in appropriate location
Respiratory Symptoms Questionnaire
时间窗: Measured monthly baseline to endpoint (24 months after baseline)
Validated Respiratory Symptoms Questionnaire (RSQ) to assess frequency of respiratory symptoms associated with health including asthma, COPD and impact quality of life. This 3 item scale has a range of 3 to 12, with higher values indicating more respiratory symptoms.
Depression
时间窗: Measured monthly baseline to endpoint (24 months after baseline)
Depression measured by the Patient Health Questionnaire (PHQ) two item scale with a possible overall score of 0-6, with higher scores indicating more depressive symptoms.
Generalized Anxiety Disorder (GAD)
时间窗: Measured monthly from baseline to endpoint (24 months after baseline)
Anxiety as measured by the Generalized Anxiety Disorder two item scale. An aggregate score from 0-6 is possible, with a higher score indicated more symptoms of anxiety.
次要结局
- DIY Air Cleaner Use(Measured continuously from when a participant enters the intervention phase (either 3 or 12 months after baseline) to endpoint (24 months after baseline))
- DIY Air Cleaner Fan Speed(Measured continuously from when a participant enters the intervention phase (either 3 or 12 months after baseline) to endpoint (24 months after baseline))
- DIY Air Cleaner Maintenance(Measured at quarterly home visits from when participants enter the intervention to endpoint (24 months after baseline))
- General Self Efficacy Scale(Measured monthly from baseline to endpoint (24 months after baseline))
- Lung Function(Measured at multiple time points - quarterly at home visits, monthly by participants, and daily (up to 3 days) after poor air quality event from baseline to endpoint (24 months after baseline))
- Blood Pressure(Measured quarterly baseline through endpoint (24 months after baseline))