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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384625
• Other study ID #: 361378
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: April 2024
• Source: University of Montana
• Contact: Ethan S Walker, PhD
• Phone: 406-243-2063
• Email: ethan.walker[@]umontana.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among patients who have undergone recent percutaneous coronary intervention procedures. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adult of at least 20 years of age

• Undergone a percutaneous coronary intervention (PCI) procedure at the Providence Heart Institute (PHI).

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Environmental Exposure
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Montana	Providence Heart Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the implementation of an indoor air pollution intervention.	As an implementation study, the investigators will administer the AIRWISE intervention to 20 cardiovascular patients 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	Fine particulate matter (PM2.5)	Measure indoor PM2.5 concentrations among participant households during intervention evaluation.	6 months
Secondary	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