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Not yet recruiting NCT07539987

Evaluation of a Novel Indoor Air Pollution Intervention Among Older Adults

No phase Interventional Cardiovascular Diseases Blood Pressure Glycated Hemoglobin (HbA1c) Cholesterol

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), Portable Air Cleaner (PAC) Control.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases, Blood Pressure, Glycated Hemoglobin (HbA1c), Cholesterol. Basic parameters: 55 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • 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 ai
  • 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.

Primary outcome measures

  • Predicting Risk of CVD EVENTs (PREVENT) Score [Time frame: 0, 6, 12 months]
Secondary outcome measures (12)
  • Life's Essential 8 (LE8) Score [Time frame: 0, 6, 12 months]
  • Indoor PM2.5 [Time frame: Continuous at 2-minute intervals]
  • Indoor VOCs [Time frame: Continuous at 2-minute intervals]
  • Glycated hemoglobin [Time frame: 0, 6, 12 months]
  • Estimated Glomerular Filtration Rate [Time frame: 0, 6, 12 months]
  • Total cholesterol [Time frame: 0, 6, 12 months]
  • HDL cholesterol [Time frame: 0, 6, 12 months]
  • LDL cholesterol [Time frame: 0, 6, 12 months]
  • CRP [Time frame: 0, 6, 12 months]
  • ESR [Time frame: 0, 6, 12 months]
  • Uric acid [Time frame: 0, 6, 12 months]
  • CBC [Time frame: 0, 6, 12 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Montana — Missoula

Identifiers

NCT: NCT07539987 · 25-0467

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗