Evaluation of a Novel Indoor Air Pollution Intervention Among Older Adults

April 13, 2026 updated by: University of Montana
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AIRWISE Intervention
Participants 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.
Behavioral: 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 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.
Active Comparator: PAC Control
Participants 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Predicting Risk of CVD EVENTs (PREVENT) Score
Time Frame: 0, 6, 12 months
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.
0, 6, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Life's Essential 8 (LE8) Score
Time Frame: 0, 6, 12 months
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.
0, 6, 12 months
Indoor PM2.5
Time Frame: Continuous at 2-minute intervals
Fine particulate matter (PM2.5), or particles that are less than 2.5 micrometers in aerodynamic diameter and a primary component of air pollution
Continuous at 2-minute intervals
Indoor VOCs
Time Frame: Continuous at 2-minute intervals
Volatile Organic Compounds (VOCs), a component of air pollution
Continuous at 2-minute intervals
Glycated hemoglobin
Time Frame: 0, 6, 12 months
A measure of blood sugar levels measured through venous blood draw and used to calculate the primary PREVENT outcome
0, 6, 12 months
Estimated Glomerular Filtration Rate
Time Frame: 0, 6, 12 months
A measure of kidney function measured through venous blood draw and used to calculate the primary PREVENT outcome
0, 6, 12 months
Total cholesterol
Time Frame: 0, 6, 12 months
Measured through venous blood draw and used to calculate the primary PREVENT outcome
0, 6, 12 months
HDL cholesterol
Time Frame: 0, 6, 12 months
High-density lipoprotein cholesterol measured through venous blood draw and used to calculate the primary PREVENT outcome
0, 6, 12 months
LDL cholesterol
Time Frame: 0, 6, 12 months
Low-density lipoprotein cholesterol measured through venous blood draw and used to calculate the primary PREVENT outcome
0, 6, 12 months
CRP
Time Frame: 0, 6, 12 months
C-reactive protein, a measure of inflammation measured through venous blood draw
0, 6, 12 months
ESR
Time Frame: 0, 6, 12 months
Erythrocyte sedimentation rate, used as a measure of inflammation measured through venous blood draw
0, 6, 12 months
Uric acid
Time Frame: 0, 6, 12 months
Used as a measure of inflammation measured through venous blood draw
0, 6, 12 months
CBC
Time Frame: 0, 6, 12 months
Used as a measure of inflammation measured through venous blood draw
0, 6, 12 months
Systolic and diastolic blood pressure
Time Frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
A risk factor for CVD and used to calculate the primary PREVENT outcome
Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
Health symptoms
Time Frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
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 at baseline, followed by once per month through study completion, for a total of 13 measurements.
Physical activity
Time Frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
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 at baseline, followed by once per month through study completion, for a total of 13 measurements.
Sleep quality
Time Frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
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 at baseline, followed by once per month through study completion, for a total of 13 measurements.
Diet
Time Frame: Measured at baseline, followed by once per month through study completion, for a total of 13 measurements.
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 at baseline, followed by once per month through study completion, for a total of 13 measurements.
BMI
Time Frame: Baseline
A risk factor for cardiovascular health and used to calculate the secondary LE8 outcome
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Montana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-0467

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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