<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/NCT03297645</url>
  </required_header>
  <id_info>
    <org_study_id>HM20010240</org_study_id>
    <secondary_id>U01HL138682</secondary_id>
    <nct_id>NCT03297645</nct_id>
  </id_info>
  <brief_title>RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities</brief_title>
  <official_title>RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Commonwealth University</source>
  <oversight_info>
    <has_dmc>Yes</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 study is to evaluate a sustainable, community-engaged program to reduce&#xD;
      asthma disparities among 5 to 11-year-old children in Richmond, Virginia. Richmond, an urban&#xD;
      center, has been named the Asthma Capital, or &quot;most challenging place to live in the U.S.&#xD;
      with asthma,&quot; by the Asthma and Allergy Foundation three times in the last 5 years. To date,&#xD;
      however, the city has no comprehensive, community-engaged asthma care program for those&#xD;
      children at highest risk for poor asthma outcomes. To address this disparity, the study team&#xD;
      engaged with community partners and completed a mixed-methods needs assessment to enhance&#xD;
      understanding of the barriers and supports to asthma care for children and their families&#xD;
      living in Richmond. Several key priority areas emerged: peer support, advocacy, treating the&#xD;
      home as a system, increased school nurse education, and coordination with schools and&#xD;
      providers. Working together, the community-engaged team translated needs assessment findings&#xD;
      to RVA Breathes, a program coordinating asthma care across 4 sectors: family, home,&#xD;
      community, and medical care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RVA Breathes includes family-based asthma self-management education (delivered by Community&#xD;
      Health Workers [CHWs] with the Institute for Public Health Innovation), homeenvironmental&#xD;
      remediation (with Richmond City Health Department's Healthy Homes Initiative), and a&#xD;
      schoolnurse component (with elementary schools in the Richmond City Public School System).&#xD;
      These interventions capitalize among existing resources and relationships with stakeholders&#xD;
      in Richmond, each of which is committed to RVA Breathes. Three-hundred children with asthma&#xD;
      and their caregivers will participate in a randomized clinical trial of RVA Breathes. After&#xD;
      completing a baseline assessment, families will be randomized to one of three conditions: 1)&#xD;
      asthma education + home remediation + school intervention, 2) asthma education + home&#xD;
      remediation and 3) comparator condition (Enhanced Standard of Care, E-SOC). Families will&#xD;
      participate in the program for 9 months and complete follow-up assessments (post-treatment&#xD;
      and 3-, 6-, and 9-month) to measure changes in healthcare utilization and the impact of the&#xD;
      program on child asthma outcomes. Conditions will be compared on the primary outcomes of&#xD;
      healthcare utilization, including asthma specific ED visits and hospital admissions, school&#xD;
      absences, and controller medication use; secondary outcomes include asthma control, symptoms,&#xD;
      and quality of life. We will also evaluate the sustainability of RVA Breathes after 9 months&#xD;
      (without active intervention), including a review of qualitative data from participants and&#xD;
      stakeholders in the program. Findings from this trial will allow for dissemination and&#xD;
      implementation of RVA Breathes as a sustainable program in the Richmond are.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2018</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>Baseline to 18 months</time_frame>
    <description>Self-reported and from billing systems/insurance reports of frequency of emergency department visits and hospitalizations due to asthma. A composite variable of frequency of emergency department visits and hospitalizations will be generated to arrive at one health care utilization outcome variable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication usage</measure>
    <time_frame>Baseline to 18 months</time_frame>
    <description>Refill data for each prescribed asthma medication will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School absences</measure>
    <time_frame>Baseline to 18 months</time_frame>
    <description>Self-reported missed school days due to asthma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma control</measure>
    <time_frame>Baseline to 18 months</time_frame>
    <description>Self-reported childhood asthma control test, which measures the frequency of daytime and nighttime asthma symptoms, activity limitations, and perception of disease control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma symptoms</measure>
    <time_frame>Baseline to 18 months</time_frame>
    <description>Caregivers will report number of symptom free days in the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child quality of life</measure>
    <time_frame>Baseline to 18 months</time_frame>
    <description>Children will complete a measure that assesses their level of quality of life related to child asthma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent quality of life</measure>
    <time_frame>Baseline to 18 months</time_frame>
    <description>Parents will complete a measure that assesses their level of quality of life related to child asthma.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>school + asthma education + home environment remediation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>asthma education + home environment remediation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>enhanced standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>School</intervention_name>
    <description>CHWs will ensure that families submit required health paperwork (e.g., asthma action plan, medication release form) and confirm with school nurses that children have the appropriate medications. School nurses will be given a standardized protocol to follow with clear guidelines for caring for students with asthma. The CHW assigned to the family will work with the school nurse to ensure that communication with the medical provider is occurring.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Asthma education</intervention_name>
    <description>CHWs will deliver evidence-based asthma education to parents and children. Content is drawn from existing asthma management programs, and adapted for families in Richmond. Between sessions, CHWs will call parents at least monthly to check in and assess family asthma management, including healthcare utilization since the last contact.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home environmental remediation</intervention_name>
    <description>Healthy Homes will complete home-based environmental assessments using evidence-based protocols. Healthy Homes will provide real-time education and share information about their findings and recommendations for action. Families are provided with low-cost intervention materials (e.g., filters, pillow covers), as well as behavioral modifications to aid in the reduction of asthma triggers in the home.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Informational mail</intervention_name>
    <description>Family will be mailed publicly available asthma information every 3 months.</description>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in Richmond Public Schools&#xD;
&#xD;
          -  Asthma-related emergency department visit/hospitalization within last year&#xD;
&#xD;
          -  Physician-diagnosed asthma&#xD;
&#xD;
          -  Richmond city resident&#xD;
&#xD;
        Caregiver inclusion: child's legal guardian living in same home for the last 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe medical or psychiatric condition (child or caregiver)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin Everhart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>June 30, 2022</last_update_submitted>
  <last_update_submitted_qc>June 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Shared data will be free of identifiers that could link findings with research participants or lead to deductive disclosure of individual subjects.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After the grant period has ended, data have been de-identified, and major study hypotheses have been tested.</ipd_time_frame>
    <ipd_access_criteria>Researchers should contact the study PI.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03297645/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>June 29, 2023</submitted>
    <returned>July 21, 2023</returned>
    <submitted>August 2, 2023</submitted>
    <returned>August 28, 2023</returned>
    <submitted>September 12, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03297645
org study id: HM20010240
secondary id: U01HL138682
nct id: NCT03297645
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to evaluate a sustainable, community-engaged program to reduce
      asthma disparities among 5 to 11-year-old children in Richmond, Virginia. Richmond, an urban
      center, has been named the Asthma Capital, or "most challenging place to live in the U.S.
      with asthma," by the Asthma and Allergy Foundation three times in the last 5 years. To date,
      however, the city has no comprehensive, community-engaged asthma care program for those
      children at highest risk for poor asthma outcomes. To address this disparity, the study team
      engaged with community partners and completed a mixed-methods needs assessment to enhance
      understanding of the barriers and supports to asthma care for children and their families
      living in Richmond. Several key priority areas emerged: peer support, advocacy, treating the
      home as a system, increased school nurse education, and coordination with schools and
      providers. Working together, the community-engaged team translated needs assessment findings
      to RVA Breathes, a program coordinating asthma care across 4 sectors: family, home,
      community, and medical care.
RVA Breathes includes family-based asthma self-management education (delivered by Community
      Health Workers [CHWs] with the Institute for Public Health Innovation), homeenvironmental
      remediation (with Richmond City Health Department's Healthy Homes Initiative), and a
      schoolnurse component (with elementary schools in the Richmond City Public School System).
      These interventions capitalize among existing resources and relationships with stakeholders
      in Richmond, each of which is committed to RVA Breathes. Three-hundred children with asthma
      and their caregivers will participate in a randomized clinical trial of RVA Breathes. After
      completing a baseline assessment, families will be randomized to one of three conditions: 1)
      asthma education + home remediation + school intervention, 2) asthma education + home
      remediation and 3) comparator condition (Enhanced Standard of Care, E-SOC). Families will
      participate in the program for 9 months and complete follow-up assessments (post-treatment
      and 3-, 6-, and 9-month) to measure changes in healthcare utilization and the impact of the
      program on child asthma outcomes. Conditions will be compared on the primary outcomes of
      healthcare utilization, including asthma specific ED visits and hospital admissions, school
      absences, and controller medication use; secondary outcomes include asthma control, symptoms,
      and quality of life. We will also evaluate the sustainability of RVA Breathes after 9 months
      (without active intervention), including a review of qualitative data from participants and
      stakeholders in the program. Findings from this trial will allow for dissemination and
      implementation of RVA Breathes as a sustainable program in the Richmond are.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Health care utilization
time frame: Baseline to 18 months
description: Self-reported and from billing systems/insurance reports of frequency of emergency department visits and hospitalizations due to asthma. A composite variable of frequency of emergency department visits and hospitalizations will be generated to arrive at one health care utilization outcome variable.
measure: Medication usage
time frame: Baseline to 18 months
description: Refill data for each prescribed asthma medication will be used.
measure: School absences
time frame: Baseline to 18 months
description: Self-reported missed school days due to asthma
measure: Asthma control
time frame: Baseline to 18 months
description: Self-reported childhood asthma control test, which measures the frequency of daytime and nighttime asthma symptoms, activity limitations, and perception of disease control.
measure: Asthma symptoms
time frame: Baseline to 18 months
description: Caregivers will report number of symptom free days in the last 7 days.
measure: Child quality of life
time frame: Baseline to 18 months
description: Children will complete a measure that assesses their level of quality of life related to child asthma.
measure: Parent quality of life
time frame: Baseline to 18 months
description: Parents will complete a measure that assesses their level of quality of life related to child asthma.
arm group label: Arm 1
arm group type: Experimental
description: school + asthma education + home environment remediation
arm group label: Arm 2
arm group type: Experimental
description: asthma education + home environment remediation
arm group label: Arm 3
arm group type: Active Comparator
description: enhanced standard of care
intervention type: Behavioral
intervention name: School
description: CHWs will ensure that families submit required health paperwork (e.g., asthma action plan, medication release form) and confirm with school nurses that children have the appropriate medications. School nurses will be given a standardized protocol to follow with clear guidelines for caring for students with asthma. The CHW assigned to the family will work with the school nurse to ensure that communication with the medical provider is occurring.
arm group label: Arm 1
intervention type: Behavioral
intervention name: Asthma education
description: CHWs will deliver evidence-based asthma education to parents and children. Content is drawn from existing asthma management programs, and adapted for families in Richmond. Between sessions, CHWs will call parents at least monthly to check in and assess family asthma management, including healthcare utilization since the last contact.
arm group label: Arm 1
arm group label: Arm 2
intervention type: Behavioral
intervention name: Home environmental remediation
description: Healthy Homes will complete home-based environmental assessments using evidence-based protocols. Healthy Homes will provide real-time education and share information about their findings and recommendations for action. Families are provided with low-cost intervention materials (e.g., filters, pillow covers), as well as behavioral modifications to aid in the reduction of asthma triggers in the home.
arm group label: Arm 1
arm group label: Arm 2
intervention type: Behavioral
intervention name: Informational mail
description: Family will be mailed publicly available asthma information every 3 months.
arm group label: Arm 3
criteria: 
gender: All
minimum age: 5 Years
maximum age: 11 Years
healthy volunteers: No
last name: Robin Everhart, PhD
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: Yes
ipd description: Shared data will be free of identifiers that could link findings with research participants or lead to deductive disclosure of individual subjects.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: After the grant period has ended, data have been de-identified, and major study hypotheses have been tested.
ipd access criteria: Researchers should contact the study PI.
provided document: 
submitted: June 29, 2023
returned: July 21, 2023
submitted: August 2, 2023
returned: August 28, 2023
submitted: September 12, 2023