Evaluation of a Novel Indoor Air Pollution Intervention Among Older Adults

NCT07539987 | Not Yet Recruiting DMC

• 1 other identifier: 25-0467
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases; Blood Pressure; Glycated Hemoglobin (HbA1c); Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Indoor Air Quality; Particulate Matter; Health Behavior

Outcome Measures

Primary Outcomes (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.

  0, 6, 12 months

Secondary Outcomes (18)

• Life's Essential 8 (LE8) Score

  0, 6, 12 months

• Indoor PM2.5

  Continuous at 2-minute intervals

• Indoor VOCs

  Continuous at 2-minute intervals

• Glycated hemoglobin

  0, 6, 12 months

• Estimated Glomerular Filtration Rate

  0, 6, 12 months

Study Arms (2)

AIRWISE Intervention

EXPERIMENTAL

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)

PAC Control

ACTIVE COMPARATOR

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

Interventions

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

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.

AIRWISE Intervention

Portable Air Cleaner (PAC) Control OTHER

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.

PAC Control

Eligibility Criteria

• Age: 55 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age one primary residence (5+ days per week)
• have an electronic device, email address, and reliable internet at home for survey submission

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Montana: lead

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Health Behavior

Interventions

Educational Status; Chromosomes, Artificial, P1 Bacteriophage

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Chromosomes, Artificial; Chromosomes; Genetic Structures; Genetic Phenomena; Genetic Vectors

Central Study Contacts

Ethan S Walker, PhD

CONTACT

406-243-2063; ethan.walker@umontana.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)