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Cardiovascular DiseasesNCT07539987

Evaluation of a Novel Indoor Air Pollution Intervention Among Older Adults

A study testing Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE) in people with Cardiovascular Diseases and Blood Pressure, run by University of Montana at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 55 to 79 years
What is being tested?
Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteUnited States
Study dates
Aug 2026to Jul 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 55 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ethan S Walker, PhD contact

406-243-2063

ethan.walker@umontana.edu

United States1 site
  • University of Montana

    Missoula, Montana, 59812

    Ethan S Walker, PhD, 406-243-2063, ethan.walker@umontana.edu

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), Portable Air Cleaner (PAC) Control
Medical subject headings
Cardiovascular Diseases, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE)Behavioural

    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 air quality. Recommendations on the decision matrix include simple strategies to reduce air pollution exposures, including increasing use and fan speed of portable air cleaners, opening or closing windows to change ventilation, and changing activities such as physical activity, cooking, and cleaning. This integrated approach promotes sustained behavior change by aligning with all key HBM constructs.

  • Portable Air Cleaner (PAC) ControlOther

    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.

Study groups in NCT07539987
Study groupRoleWhat they receive
AIRWISE InterventionExperimentalParticipants 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.
Receives: Behavioral: Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE)
PAC ControlActive comparatorParticipants 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.
Receives: Other: Portable Air Cleaner (PAC) Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Predicting Risk of CVD EVENTs (PREVENT) Score

    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.

    Measured: 0, 6, 12 months

Secondary outcomes (18)
  1. Life's Essential 8 (LE8) Score

    Validated metric of cardiovascular health called Life's Essential 8 (LE8). The score ranges from 0 to 100, with higher scores indicating better cardiovascular health and lower risk of adverse cardiovascular outcomes.

    Measured: 0, 6, 12 months

  2. Indoor PM2.5

    Fine particulate matter (PM2.5), or particles that are less than 2.5 micrometers in aerodynamic diameter and a primary component of air pollution

    Measured: Continuous at 2-minute intervals

  3. Indoor VOCs

    Volatile Organic Compounds (VOCs), a component of air pollution

    Measured: Continuous at 2-minute intervals

  4. Glycated hemoglobin

    A measure of blood sugar levels measured through venous blood draw and used to calculate the primary PREVENT outcome

    Measured: 0, 6, 12 months

  5. Estimated Glomerular Filtration Rate

    A measure of kidney function measured through venous blood draw and used to calculate the primary PREVENT outcome

    Measured: 0, 6, 12 months

  6. Total cholesterol

    Measured through venous blood draw and used to calculate the primary PREVENT outcome

    Measured: 0, 6, 12 months

  7. HDL cholesterol

    High-density lipoprotein cholesterol measured through venous blood draw and used to calculate the primary PREVENT outcome

    Measured: 0, 6, 12 months

  8. LDL cholesterol

    Low-density lipoprotein cholesterol measured through venous blood draw and used to calculate the primary PREVENT outcome

    Measured: 0, 6, 12 months

  9. CRP

    C-reactive protein, a measure of inflammation measured through venous blood draw

    Measured: 0, 6, 12 months

  10. ESR

    Erythrocyte sedimentation rate, used as a measure of inflammation measured through venous blood draw

    Measured: 0, 6, 12 months

  11. Uric acid

    Used as a measure of inflammation measured through venous blood draw

    Measured: 0, 6, 12 months

  12. CBC

    Used as a measure of inflammation measured through venous blood draw

    Measured: 0, 6, 12 months

  13. Systolic and diastolic blood pressure

    A risk factor for CVD and used to calculate the primary PREVENT outcome

    Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.

  14. Health symptoms

    Health symptoms will be reported in a questionnaire and used as a measure of quality of life. The questionnaire includes 6 questions and asks about recent illness and frequency of symptoms including eye irritation, blurred vision, wheezing, cough, throat irritation, difficulty breathing, excessive mucus, nose irritation, and headache.

    Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.

  15. Physical activity

    A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome. Physical activity will be reported in a questionnaire. The questionnaire includes 12 questions and asks about type, duration, and location of recent physical activities.

    Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.

  16. Sleep quality

    A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome. Sleep quality will be reported in a questionnaire. The questionnaire includes 9 questions and asks about duration, quality, barriers, and facilitators of sleep over the previous month.

    Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.

  17. Diet

    A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome. Diet will be reported in a questionnaire. The questionnaire includes 16 questions and asks about the recent frequency and amount of consuming 16 different types of foods.

    Measured: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.

  18. BMI

    A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionJul 2030 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07539987
Sponsor's protocol ID
25-0467
Status last verified
Apr 2026
First submitted
6 Apr 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE) in people with Cardiovascular Diseases and Blood Pressure, run by University of Montana at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ethan S Walker, PhD (406-243-2063, ethan.walker@umontana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Predicting Risk of CVD EVENTs (PREVENT) Score (time frame: 0, 6, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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