Home Health and Air Pollution Study

January 8, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • UCHealth
      • Fort Collins, Colorado, United States, 80523
        • Colorado State University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Colorado State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver
Access Sensor Technologies, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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