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

NCT06384625 | Completed

• 1 other identifier: 361378
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease; Cardiovascular Diseases; Environmental Exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fine particulate matter (PM2.5)

  6 months

• Life's Essential 8

  6 months

Study Arms (1)

Air pollution intervention implementation

OTHER

AIRWISE intervention implementation

Other: AIRWISE

Interventions

AIRWISE OTHER

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.

Air pollution intervention implementation

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Montana: lead
• Providence Heart Institute: collaborator

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

Location

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 25, 2024
• Study Start: July 24, 2024
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)