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Completed

NCT Number: NCT06384625

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Environmental Exposure Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Montana

Missoula, Montana, 59812, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Evaluate the implementation of an indoor air pollution intervention.

    Time frame: 6 months

    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.

Secondary outcomes

  1. Fine particulate matter (PM2.5)

    Time frame: 6 months

    Measure indoor PM2.5 concentrations among participant households during intervention evaluation.

  2. Life's Essential 8

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Montana

Other

Collaborators

  • Providence Heart Institute

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2024
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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