xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06030336</url>
    </required_header>
    <id_info>
      <org_study_id>23 - 0817</org_study_id>
      <nct_id>NCT06030336</nct_id>
    </id_info>
    <brief_title>Home Health and Air Pollution Study</brief_title>
    <official_title>Home Health and Air Pollution Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Colorado State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Access Sensor Technologies, LLC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Colorado State University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about whether indoor air quality will improve&#xD;
        over time in homes where occupants receive personalized information about levels of&#xD;
        health-relevant air pollutants that includes practical, budget-friendly, and culturally&#xD;
        relevant recommendations on actions they can take to improve their home's air quality. The&#xD;
        rationale for the investigators' approach is that a rigorous intervention study design will&#xD;
        generate robust evidence on the value of the in-home environmental data. Participating homes&#xD;
        in both the intervention and control groups will receive three, one-week Home Health Box&#xD;
        deployments spaced six weeks apart. After each of the first two deployments, homes in the&#xD;
        intervention group will receive a Home Health Report with personalized information about&#xD;
        in-home levels of health-relevant air pollutants and cost-sensitive recommendations on&#xD;
        actions occupants can take to improve their home's air quality. The investigators will (a)&#xD;
        investigate whether and how air quality changes over time in control and intervention homes&#xD;
        and (b) survey intervention households on the utility of the Home Health Reports.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study participation will involve: (i) an intake survey; (ii) random assignment to the&#xD;
        intervention or control group (this will be done in blocks of 4 households, to maintain&#xD;
        balance in the intervention and control groups over the course of study enrollment); (iii)&#xD;
        three in-home air quality monitoring deployments with the Home Health Box; (iv) three Home&#xD;
        Health Reports (for those randomly assigned to the intervention group) generated from data&#xD;
        the Home Health Box provides; and (v) a follow-up survey in a subset of intervention&#xD;
        households to investigate the value and utility of the Home Health Report. The Home Health&#xD;
        Report will provide quantitative information about health-relevant pollutants (fine&#xD;
        particulate matter, carbon dioxide, nitrogen dioxide, and volatile organic compounds), their&#xD;
        levels compared to health-based guidelines, their potential sources, as well as no- and&#xD;
        low-cost actions occupants could take to improve indoor air quality. The Home Health Report&#xD;
        will be designed to maximize utility to residents. Each Home Health Report will be provided&#xD;
        within approximately three to four weeks after the corresponding Home Health Box has been&#xD;
        received from the household. The second Home Health Box deployment will occur within several&#xD;
        weeks to one month of the household receiving their first Home Health Report. The third and&#xD;
        final Home Health Box deployment will occur within several weeks to one month of the&#xD;
        household receiving their second Home Health. Households in the control group will also&#xD;
        receive three Home Health Box deployments spaced approximately four to eight weeks apart, but&#xD;
        will not receive Home Health Reports after the first and second deployments. At the close of&#xD;
        their participation in the study, households in both the intervention and control groups will&#xD;
        receive a comprehensive Home Health Report, including results from all three Home Health Box&#xD;
        deployments and recommended actions occupants could take to improve their home air quality.&#xD;
        In total, participation in this study will last between four to six months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Random assignment to the intervention or control group in blocks of four households, to maintain balance in the intervention and control groups over the course of study enrollment.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>In-Home Air Quality</measure>
      <time_frame>from eight to up to 24 weeks</time_frame>
      <description>In-home concentrations of fine particulate matter, nitrogen dioxide, and volatile organic compounds.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Indoor Air Quality</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Home Health Report</intervention_name>
      <description>The Home Health Report has been described in the intervention arm description.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  living in home for at least next six months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  if participants will not be living in the same household within six months of&#xD;
               enrollment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ellison Carter, PhD</last_name>
      <phone>2192417141</phone>
      <email>ellison.carter@colostate.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hope Cruse</last_name>
      <phone>(303) 724 - 0732</phone>
      <email>hope.cruse@cuanschutz.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Colorado State University</name>
        <address>
          <city>Fort Collins</city>
          <state>Colorado</state>
          <zip>80523</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ellison Carter, PhD</last_name>
        <phone>219-241-7141</phone>
        <email>ellison.carter@colostate.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Tryner J, Phillips M, Quinn C, Neymark G, Wilson A, Jathar SH, Carter E, Volckens J. Design and Testing of a Low-Cost Sensor and Sampling Platform for Indoor Air Quality. Build Environ. 2021 Dec;206:108398. doi: 10.1016/j.buildenv.2021.108398. Epub 2021 Sep 28.</citation>
      <PMID>34764540</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Colorado State University</investigator_affiliation>
      <investigator_full_name>Ellison Carter</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_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_time_frame>
      <ipd_access_criteria>Researchers will be eligible for access if they are members of the overall study team.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06030336
  org study id: 23 - 0817
  nct id: NCT06030336
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Random assignment to the intervention or control group in blocks of four households, to maintain balance in the intervention and control groups over the course of study enrollment.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: In-Home Air Quality
  time frame: from eight to up to 24 weeks
  description: In-home concentrations of fine particulate matter, nitrogen dioxide, and volatile organic compounds.
  arm group label: Intervention
  arm group type: Experimental
  description: 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.
  arm group label: Control
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Home Health Report
  description: The Home Health Report has been described in the intervention arm description.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ellison Carter, PhD
  phone: 2192417141
  email: ellison.carter@colostate.edu
  last name: Hope Cruse
  phone: (303) 724 - 0732
  email: hope.cruse@cuanschutz.edu
  facility: 
  contact: 
  country: United States
  citation: Tryner J, Phillips M, Quinn C, Neymark G, Wilson A, Jathar SH, Carter E, Volckens J. Design and Testing of a Low-Cost Sensor and Sampling Platform for Indoor Air Quality. Build Environ. 2021 Dec;206:108398. doi: 10.1016/j.buildenv.2021.108398. Epub 2021 Sep 28.
  PMID: 34764540
  responsible party type: Principal Investigator
  investigator affiliation: Colorado State University
  investigator full name: Ellison Carter
  investigator title: Associate Professor
  sharing ipd: Yes
  ipd 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 info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd 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 access criteria: Researchers will be eligible for access if they are members of the overall study team.