<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/NCT04470180</url>
  </required_header>
  <id_info>
    <org_study_id>192091</org_study_id>
    <nct_id>NCT04470180</nct_id>
  </id_info>
  <brief_title>Virtual Teach to Goal vs. Brief Intervention Inhaler Study-outpatient</brief_title>
  <official_title>An RCT of Virtual Teach-to-Goal Versus Brief Instruction for Children With Asthma in Clinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Thoracic Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</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>
      This study aims to evaluate the comparative effectiveness of a high-fidelity, low-resource,&#xD;
      and feasible model versus a standardized brief intervention that mimics usual care to deliver&#xD;
      tailored inhaler technique education to children with asthma via a randomized clinical trial.&#xD;
      We have already conducted a trial of V-TTG among elementary school-aged children hospitalized&#xD;
      in the inpatient setting and we now aim to test this tool in the outpatient clinic setting&#xD;
      among a broader pediatric patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is the most common chronic childhood condition and has significant adverse&#xD;
      consequences. One in 12 United States children has asthma, resulting in 13.4 million missed&#xD;
      school days, 1 million emergency department visits, and 140,000 hospitalizations annually.&#xD;
      Urban, minority, and underserved youth are disproportionally affected. On Chicago's South&#xD;
      Side, one-in-five children have an asthma diagnosis; over half visit an urgent care or&#xD;
      emergency department (55%), miss school (51.2%), or require parents to miss work annually due&#xD;
      to asthma (56.1%).&#xD;
&#xD;
      Effective self-management is crucial to optimize asthma care and improve outcomes. A key&#xD;
      barrier to self-management is the improper use of respiratory inhalers, which limits disease&#xD;
      control. Better inhaler technique is associated with improved asthma outcomes for children.&#xD;
      Assessment and education of inhaler technique are recommended at all healthcare encounters;&#xD;
      however, it is limited in practice because it is resource-intensive (both personnel and time)&#xD;
      and lacks fidelity. Thus, low-resource interventions that accurately teach inhaler skills are&#xD;
      needed to impact pediatric asthma outcomes.&#xD;
&#xD;
      Teach-to-Goal (TTG) is a patient-centered strategy that uses tailored rounds of teaching and&#xD;
      assessments to ensure mastery of inhaler technique. Studies show it is effective but&#xD;
      resource-intensive. A &quot;virtual TTG&quot; (V-TTG) intervention represents an opportunity to deliver&#xD;
      inhaler technique education with a high-fidelity, low-resource, and feasible strategy. The&#xD;
      module utilizes innovative learning technology with video demonstrations and assessment&#xD;
      questions to tailor education to each user; the cycles of assessment and education continues&#xD;
      until satisfactory mastery is achieved. Our team developed a V-TTG intervention for adults&#xD;
      with demonstrated efficacy. It remains unknown whether this interactive and adaptive module&#xD;
      will be feasible and effective in the pediatric population due to varied developmental levels&#xD;
      and parental involvement in care.&#xD;
&#xD;
      Virtual Teach-to-Goal (V-TTG) holds the potential to improve inhaler technique in children;&#xD;
      however, because learning theory indicates children and adults learn differently, the same&#xD;
      learning module cannot be utilized. We have already constructed V-TTG for children with&#xD;
      feedback from children with asthma, parents, and healthcare professionals. The learning&#xD;
      module is tailored for age by using developmentally and age-appropriate vocabulary, concepts,&#xD;
      format, and pacing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">November 5, 2021</completion_date>
  <primary_completion_date type="Actual">November 5, 2021</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants with effective inhaler use (&gt;75% steps correct) post-intervention with V-TTG versus BI</measure>
    <time_frame>12 months</time_frame>
    <description>Inhaler technique will be assessed based on a validated published checklist, which was developed and validated by Dr. Press15 and utilized in my preliminary research with children (see Preliminary Studies). For this primary outcome, we will account for the pre-intervention technique to account for any differences in baseline of the two groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of inhaler technique steps correct pre- and post-V-TTG education</measure>
    <time_frame>At baseline</time_frame>
    <description>Evaluation of inhaler technique before and after education using validated checklist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of inhaler technique steps correct at 1 month</measure>
    <time_frame>1-month after enrollment</time_frame>
    <description>Evaluation of inhaler technique 1-month after education/baseline session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Asthma Control Survey</measure>
    <time_frame>12-months</time_frame>
    <description>Assessed using validated survey measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Asthma Impact</measure>
    <time_frame>12-months</time_frame>
    <description>Assessed using validated survey measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Caregiver Quality of Life</measure>
    <time_frame>12-months</time_frame>
    <description>Assessed using validated survey measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Child Asthma Management Self-Efficacy</measure>
    <time_frame>12-months</time_frame>
    <description>Assessed using validated survey measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of healthcare encounters self-reported and EHR-recorded since baseline</measure>
    <time_frame>12-months</time_frame>
    <description>Healthcare utilization measured via program-specific questionnaire delivered to parent and child as well as manual review of medical records</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Asthma in Children</condition>
  <arm_group>
    <arm_group_label>Virtual Teach-to-Goal (V-TTG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>They will be randomized to receive education via a virtual learning module.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standardized brief intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention that mimics usual care to deliver inhaler technique education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Teach to Goal</intervention_name>
    <description>Participants will complete inhaler education on a tablet device.</description>
    <arm_group_label>Virtual Teach-to-Goal (V-TTG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Instruction</intervention_name>
    <description>Participants will be read out loud instruction on how to use their inhaler.</description>
    <arm_group_label>standardized brief intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Families will be included in the study if:&#xD;
&#xD;
               1. The child is between the ages of 6-17 years old&#xD;
&#xD;
               2. The child has a diagnosis of asthma, wheezing, or bronchospasm&#xD;
&#xD;
               3. The child has been or is seen in general pediatrics, pediatric pulmonary, or&#xD;
                  pediatric allergy clinic at the University of Chicago Medical Center&#xD;
&#xD;
               4. The child is taking medication for asthma, wheezing, or bronchospasm (either a&#xD;
                  controller medication or a quick-relief medication)&#xD;
&#xD;
               5. The family has acess to wifi and/or data that supports virtual video-based&#xD;
                  platforms (if study is done virtually)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Families will be excluded from the study if:&#xD;
&#xD;
               1. The child/parent decline or unable to provide consent/assent&#xD;
&#xD;
               2. The child/parent does not speak/read English&#xD;
&#xD;
               3. The child cannot use an inhaler by themselves without a mask&#xD;
&#xD;
               4. The child previously participated in this study&#xD;
&#xD;
               5. The family does not have access to wifi and/or data that supports virtual&#xD;
                  video-based platforms (if study done virtually)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Volerman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>April 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>February 17, 2022</last_update_submitted>
  <last_update_submitted_qc>February 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 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>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 14, 2022</submitted>
    <returned>January 18, 2023</returned>
  </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/NCT04470180
org study id: 192091
nct id: NCT04470180
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the comparative effectiveness of a high-fidelity, low-resource,
      and feasible model versus a standardized brief intervention that mimics usual care to deliver
      tailored inhaler technique education to children with asthma via a randomized clinical trial.
      We have already conducted a trial of V-TTG among elementary school-aged children hospitalized
      in the inpatient setting and we now aim to test this tool in the outpatient clinic setting
      among a broader pediatric patient population.
Asthma is the most common chronic childhood condition and has significant adverse
      consequences. One in 12 United States children has asthma, resulting in 13.4 million missed
      school days, 1 million emergency department visits, and 140,000 hospitalizations annually.
      Urban, minority, and underserved youth are disproportionally affected. On Chicago's South
      Side, one-in-five children have an asthma diagnosis; over half visit an urgent care or
      emergency department (55%), miss school (51.2%), or require parents to miss work annually due
      to asthma (56.1%).

      Effective self-management is crucial to optimize asthma care and improve outcomes. A key
      barrier to self-management is the improper use of respiratory inhalers, which limits disease
      control. Better inhaler technique is associated with improved asthma outcomes for children.
      Assessment and education of inhaler technique are recommended at all healthcare encounters;
      however, it is limited in practice because it is resource-intensive (both personnel and time)
      and lacks fidelity. Thus, low-resource interventions that accurately teach inhaler skills are
      needed to impact pediatric asthma outcomes.

      Teach-to-Goal (TTG) is a patient-centered strategy that uses tailored rounds of teaching and
      assessments to ensure mastery of inhaler technique. Studies show it is effective but
      resource-intensive. A "virtual TTG" (V-TTG) intervention represents an opportunity to deliver
      inhaler technique education with a high-fidelity, low-resource, and feasible strategy. The
      module utilizes innovative learning technology with video demonstrations and assessment
      questions to tailor education to each user; the cycles of assessment and education continues
      until satisfactory mastery is achieved. Our team developed a V-TTG intervention for adults
      with demonstrated efficacy. It remains unknown whether this interactive and adaptive module
      will be feasible and effective in the pediatric population due to varied developmental levels
      and parental involvement in care.

      Virtual Teach-to-Goal (V-TTG) holds the potential to improve inhaler technique in children;
      however, because learning theory indicates children and adults learn differently, the same
      learning module cannot be utilized. We have already constructed V-TTG for children with
      feedback from children with asthma, parents, and healthcare professionals. The learning
      module is tailored for age by using developmentally and age-appropriate vocabulary, concepts,
      format, and pacing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion of participants with effective inhaler use (>75% steps correct) post-intervention with V-TTG versus BI
time frame: 12 months
description: Inhaler technique will be assessed based on a validated published checklist, which was developed and validated by Dr. Press15 and utilized in my preliminary research with children (see Preliminary Studies). For this primary outcome, we will account for the pre-intervention technique to account for any differences in baseline of the two groups
measure: Number of inhaler technique steps correct pre- and post-V-TTG education
time frame: At baseline
description: Evaluation of inhaler technique before and after education using validated checklist
measure: Number of inhaler technique steps correct at 1 month
time frame: 1-month after enrollment
description: Evaluation of inhaler technique 1-month after education/baseline session
measure: Score of Asthma Control Survey
time frame: 12-months
description: Assessed using validated survey measure
measure: Score of Asthma Impact
time frame: 12-months
description: Assessed using validated survey measure
measure: Score of Caregiver Quality of Life
time frame: 12-months
description: Assessed using validated survey measure
measure: Score of Child Asthma Management Self-Efficacy
time frame: 12-months
description: Assessed using validated survey measure
measure: Number of healthcare encounters self-reported and EHR-recorded since baseline
time frame: 12-months
description: Healthcare utilization measured via program-specific questionnaire delivered to parent and child as well as manual review of medical records
arm group label: Virtual Teach-to-Goal (V-TTG)
arm group type: Experimental
description: They will be randomized to receive education via a virtual learning module.
arm group label: standardized brief intervention
arm group type: Active Comparator
description: Intervention that mimics usual care to deliver inhaler technique education.
intervention type: Behavioral
intervention name: Virtual Teach to Goal
description: Participants will complete inhaler education on a tablet device.
arm group label: Virtual Teach-to-Goal (V-TTG)
intervention type: Behavioral
intervention name: Brief Instruction
description: Participants will be read out loud instruction on how to use their inhaler.
arm group label: standardized brief intervention
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Anna Volerman, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No
submitted: April 14, 2022
returned: January 18, 2023