Indoor Air QualityNCT07815652
DIY Indoor Air Cleaner Study in Rural and Urban Communities in Colorado
A study testing DIY Air Cleaner and Breathe Clean Video in people with Indoor Air Quality, run by University of Colorado, Denver.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Indoor Air Quality
- What is being tested?
- DIY Air Cleaner and Breathe Clean Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Owns an air cleaner
- Does not speak Spanish or English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mountain West Hub: Building Resilience to Address Health Impacts of Air Quality in Rural and Urban Communities
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.
Read the detailed description
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.
- Conditions
- Indoor Air Quality
- Being tested
- DIY Air Cleaner and Breathe Clean Video
- Keywords
- indoor air quality, indoor air cleaners, implementation study, physical health, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIY Air Cleaner and Breathe Clean VideoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Implementation | Experimental | Early implementation arm will receive the intervention early in the study, immediately following a 3 month baseline period Receives: Behavioral: DIY Air Cleaner and Breathe Clean Video |
| Delayed Implementation | Experimental | Delayed implementation arm will also receive the intervention, 9 months after the early implementation arm. Receives: Behavioral: DIY Air Cleaner and Breathe Clean Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indoor Air Quality
Continuous PM2.5 concentration in room where DIYaf is located
Measured: 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.
Measured: 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.
Measured: Measured at baseline and endpoint (24 months later)
DIY Air Cleaner Adoption
Whether DIY air cleaner is placed in house in appropriate location
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured monthly from baseline to endpoint (24 months after baseline)
Secondary outcomes (6)
DIY Air Cleaner Use
Reported number of hours in a day the DIY air cleaner is used. Measured by ampere meter.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured monthly from baseline to endpoint (24 months after baseline)
Lung Function
Peak Expiratory Flow (PEF) (L/min)
Measured: 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
Measured: Measured quarterly baseline through endpoint (24 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indoor Air QualityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge design where each group will receive enter the intervention at different time points.
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kathy James, PhD, Principal investigator, University of Colorado, DenverKatie Dickinson, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815652
- Sponsor's protocol ID
- 25-1857
- Other IDs
- OT2HL158287
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided