Developing and Evaluating an Indoor Air Pollution Intervention Among Cardiovascular Patients: the AIRWISE Study

This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among adults 55 years of age or older. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Heart Disease; Environmental Exposure
• Intervention / Treatment: Other: AIRWISE

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Montana
    • Missoula, Montana, United States, 59812
      • University of Montana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult of at least 55 years of age
• One primary residence (5+ days per week)
• Own a computer or electronic device (tablet or phone with web browser), and reliable internet connection or cell phone service (required to submit study surveys)
• Access to a working email address (required to submit study surveys)
• Electricity in the home (required to power the study equipment)

Exclusion Criteria:

• Current smoking of any kind (tobacco, cannabis, vape pens, cigars, etc.) or living in a household with someone who currently smokes
• Current use of stand-alone home high efficiency purified air (HEPA) filtration or PAC unit in the home
• Intention to move in the next 6 months
• Another person in the household is enrolled in this study (one person per household can enroll)
• Having any health condition that prevents the participants from having blood pressure measured using an upper-arm cuff: lymphedema, paresis or paralysis, arterial or venous lines/catheters, dialysis shunt, recent surgical wounds, or mastectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Air pollution intervention implementation; AIRWISE intervention implementation

Other: AIRWISE; AIRWISE (Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education) utilizes personal air cleaners (PACs) to filter indoor air, while enhanced aspects focus on improving compliance to PAC use. Key components include low-cost sensors (PurpleAir, Inc, USA) that change color according to air quality index (AQI) and behavioral recommendations that correspond to varying AQI levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the implementation of an indoor air pollution intervention.	As an implementation study, the investigators will administer the AIRWISE intervention to 20 adult participants (55+ years of age) and evaluate intervention fidelity, acceptance, and compliance over a 6-month period spanning the 2024 wildfire season. An important outcome measure is to understand how frequently participants use the primary intervention components that include personal air cleaners (PACs), an indoor air quality monitor that changes color based on air quality index, and educational materials. These 3 components will be evaluated via electronic surveys administered every 2 weeks over the course of the study. The investigators will use 7 Likert Scale (ordinal) questions to measure frequency of use for the intervention components. The 7 questions will be combined into a composite score of intervention use that ranges from 7 to 39, with higher scores indicating higher intervention use.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fine particulate matter (PM2.5)	Measure indoor PM2.5 concentrations among participant households during intervention evaluation.	6 months
Life's Essential 8	The investigators will prospectively collect health measures to calculate a metric called Life's Essential 8 (LE8), a construct of cardiovascular health including blood pressure, lipids, glucose, body mass index, nicotine exposure, diet, physical activity, and sleep health. LE8 ranges from 0 to 100, with the score calculated as an unweighted average of the 8 component metric scores. Overall scores of 80 to 100 are considered high, 50 to 79 considered moderate, and 0 to 49 considered low. The investigators will then assess associations between the LE8 metric and indoor PM2.5 concentrations measured using the AIRWISE sensors. The hypothesis is that higher indoor PM2.5 concentrations over the course of the study will be associated with lower LE8 scores.	6 months

Collaborators and Investigators

• Sponsor: University of Montana
• Collaborators: Providence Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Actual): November 5, 2025
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Heart Diseases; Myocardial Ischemia; Cardiovascular Diseases; Coronary Disease
• Other Study ID Numbers: 361378

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
• product manufactured in and exported from the U.S.: No