Home Health and Air Pollution Study

April 16, 2024 updated by: Ellison Carter, Colorado State University
The goal of this clinical trial is to learn about whether indoor air quality will improve over time in homes where occupants receive personalized information about levels of health-relevant air pollutants that includes practical, budget-friendly, and culturally relevant recommendations on actions they can take to improve their home's air quality. The rationale for the investigators' approach is that a rigorous intervention study design will generate robust evidence on the value of the in-home environmental data. Participating homes in both the intervention and control groups will receive three, one-week Home Health Box deployments spaced six weeks apart. After each of the first two deployments, homes in the intervention group will receive a Home Health Report with personalized information about in-home levels of health-relevant air pollutants and cost-sensitive recommendations on actions occupants can take to improve their home's air quality. The investigators will (a) investigate whether and how air quality changes over time in control and intervention homes and (b) survey intervention households on the utility of the Home Health Reports.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study participation will involve: (i) an intake survey; (ii) random assignment to the intervention or control group (this will be done in blocks of 4 households, to maintain balance in the intervention and control groups over the course of study enrollment); (iii) three in-home air quality monitoring deployments with the Home Health Box; (iv) three Home Health Reports (for those randomly assigned to the intervention group) generated from data the Home Health Box provides; and (v) a follow-up survey in a subset of intervention households to investigate the value and utility of the Home Health Report. The Home Health Report will provide quantitative information about health-relevant pollutants (fine particulate matter, carbon dioxide, nitrogen dioxide, and volatile organic compounds), their levels compared to health-based guidelines, their potential sources, as well as no- and low-cost actions occupants could take to improve indoor air quality. The Home Health Report will be designed to maximize utility to residents. Each Home Health Report will be provided within approximately three to four weeks after the corresponding Home Health Box has been received from the household. The second Home Health Box deployment will occur within several weeks to one month of the household receiving their first Home Health Report. The third and final Home Health Box deployment will occur within several weeks to one month of the household receiving their second Home Health. Households in the control group will also receive three Home Health Box deployments spaced approximately four to eight weeks apart, but will not receive Home Health Reports after the first and second deployments. At the close of their participation in the study, households in both the intervention and control groups will receive a comprehensive Home Health Report, including results from all three Home Health Box deployments and recommended actions occupants could take to improve their home air quality. In total, participation in this study will last between four to six months.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth
        • Contact:
        • Sub-Investigator:
          • Fernando Holguin, MD
      • Fort Collins, Colorado, United States, 80523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • living in home for at least next six months

Exclusion Criteria:

  • if participants will not be living in the same household within six months of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The Home Health Report will provide quantitative information about health-relevant pollutants (fine particulate matter, carbon dioxide, nitrogen dioxide, and volatile organic compounds), their levels compared to health-based guidelines, their potential sources, as well as no- and low-cost actions occupants could take to improve indoor air quality. The Home Health Report will be designed to maximize utility to residents. Each Home Health Report will be provided after the corresponding Home Health Box deployment. The second Home Health Box deployment will occur after the household receiving their first Home Health Report. The third and final Home Health Box deployment will occur within one month of the household receiving their second Home Health Report.
Behavioral: Home Health Report
The Home Health Report has been described in the intervention arm description.
No Intervention: Control
Households in the control group will also receive three Home Health deployments spaced over several months, but will not receive Home Health Reports after the first and second deployments. At the close of their participation in the study, households in the control group will receive a comprehensive Home Health Report, including results from all three Home Health Box deployments and recommended actions occupants could take to improve their home air quality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-Home Air Quality
Time Frame: from eight to up to 24 weeks
In-home concentrations of fine particulate matter, nitrogen dioxide, and volatile organic compounds.
from eight to up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Collaborators

University of Colorado, Denver
Access Sensor Technologies, LLC

Investigators

  • Principal Investigator: Ellison Carter, PhD, Colorado State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 23 - 0817

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Our human subjects work will generate a comprehensive dataset that includes information on in home exposures, in-home activities, and home air quality in the form of quantitative, reference grade information on aerosol and gas constituents in indoor air. After de-identifying these data (including location data), we will publish these data in peer-reviewed journals. We will also generate subject response data from surveys and interviews. These data will be organized, assembled, and analyzed for publication in peer-reviewed journals. Standard restrictions would apply to the secondary research use of data involving human subjects, and these data would only be made available through a written agreement with the party requesting the data, after being deidentified.

IPD Sharing Time Frame

Data will become available to researchers associated with the project via the collaborating institutions as the data are being collected and for up to three years beyond the end of the study period.

IPD Sharing Access Criteria

Researchers will be eligible for access if they are members of the overall study team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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