An interventional study of DIY Air Cleaner and Breathe Clean Video in Indoor Air Quality, sponsored by University of Colorado, Denver. Not yet recruiting. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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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.
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
Our study will address the following three aims and associated research questions (RQs):
Aim 1: Evaluate impacts of DIYac on exposure to indoor PM associated with ambient PM.
RQ2. (Effectiveness) Does adoption and use of DIYac reduce indoor PM levels, attributed to ambient PM? Hypothesis 2a: DIYac use will lead to significant decline in indoor PM levels. Hypothesis 2b: During an elevated PM event, households with DIYac will experience significantly lower indoor PM than those without DIYac. Note: this hypothesis will only be answerable if an event occurs during the intervention period.
Aim 2: Evaluate impacts of intervention on DIYac adoption, use, and maintenance.
RQ1a. (Effectiveness) Do households that are provided a DIYac successfully adopt and consistently use and maintain these filters as recommended? Hypothesis 2a: Households in the intervention condition (Group 1) will have significantly higher rates of adoption of the DIYac use than those in Group 2 (baseline). Hypothesis 2b: After intervention phase households will report improved self-efficacy, sense of agency, and hopefulness than pre-intervention.
RQ1b. (Implementation) What barriers and facilitators influence DIYac adoption, use, and maintenance across rural and urban low-resource households? Hypothesis 1b: Barriers and facilitators to DIYac implementation will include similar factors across sites, including costs (electricity and maintenance) and noise, as well as some factors that are household-specific (person with asthma) or regional (lower access to materials in urban areas). Community engagement and program design can identify strategies to address these barriers.
Aim 3: Evaluate impacts of DIYac on health outcomes (physical and mental health) and biomarkers of exposures (urinary markers).
RQ3. (Effectiveness) Does adoption and use of DIYac improve self-reported and measured physical and mental health indicators and urinary biomarkers of exposure to PM? Hypothesis 3a: DIYac use is associated with improved metrics of physical health and mental health. Hypothesis 3b: During an elevated PM event, households with DIYac will have improved metrics of physical and mental. Note: this hypothesis will only be answerable if a wildfire smoke event occurs during the intervention period.
2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 550 is above the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
Early implementation arm will receive the intervention early in the study, immediately following a 3 month baseline period
Behavioral: DIY Air Cleaner and Breathe Clean Video
Delayed implementation arm will also receive the intervention, 9 months after the early implementation arm.
Behavioral: DIY Air Cleaner and Breathe Clean Video
The intervention consists of participants in the intervention group receiving a do-it-yourself (DIY) air cleaner to be placed in the home, along with access to the "Breathe Clean" video that educates about the relationship between outdoor and indoor air quality, as well as the importance of cleaning indoor air to potentially impact health outcomes.
Indoor Air Quality
Continuous PM2.5 concentration in room where DIYaf is located
Time frame: From baseline home visit to endpoint home visit (24 months later), measured continuously.
Air Quality and Health Impacts Knowledge
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.
Time frame: Measured at baseline and 24 months later at endpoint
Air Quality and Health Perspectives
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.
Time frame: Measured at baseline and endpoint (24 months later)
DIY Air Cleaner Adoption
Whether DIY air cleaner is placed in house in appropriate location
Time frame: Measured at quarterly home visits from baseline to endpoint (24 months after baseline)
Respiratory Symptoms Questionnaire
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.
Time frame: Measured monthly baseline to endpoint (24 months after baseline)
Depression
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.
Time frame: Measured monthly baseline to endpoint (24 months after baseline)
Generalized Anxiety Disorder (GAD)
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.
Time frame: Measured monthly from baseline to endpoint (24 months after baseline)
DIY Air Cleaner Use
Reported number of hours in a day the DIY air cleaner is used. Measured by ampere meter.
Time frame: 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
This is the speed at which the DIY air cleaner fan is running - low, medium, or high setting. Measured by ampere meter.
Time frame: 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
Filter replaced every 6 months or when appearance indicates. This is reported as a yes/no for proper replacement.
Time frame: Measured at quarterly home visits from when participants enter the intervention to endpoint (24 months after baseline)
General Self Efficacy Scale
Self efficacy, measured by the General Self Efficacy Scale (GSE) three item scale. This sale uses a 5 item Likert scale, with a score ranging from 0-12. Higher scores indicate greater levels of self efficacy.
Time frame: Measured monthly from baseline to endpoint (24 months after baseline)
Lung Function
Peak Expiratory Flow (PEF) (L/min)
Time frame: 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
Blood pressure assessment by electronic monitor with arm cuffs
Time frame: Measured quarterly baseline through endpoint (24 months after baseline)
Concentration of Urinary Biomarkers
Exploratory distal outcome to measure PAHs, metals, KIM-1, NGAL, cystatin C
Time frame: Measured quarterly baseline to endpoint (24 months after baseline) for 50% of participants (randomly selected)
Community Health Indicators
Exploratory distal community-level health outcomes (daily counts of emergent and urgent care visits at local hospital)
Time frame: Daily from baseline to endpoint (24 months after baseline)
DIY Air Cleaner Cost
Cost analysis of DIY air cleaners including cost of air cleaners and replacement filters.
Time frame: Endpoint (24 months after baseline)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.
Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 27 months is above that.
Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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