<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/NCT01692080</url>
  </required_header>
  <id_info>
    <org_study_id>DU Protocol #10-11</org_study_id>
    <nct_id>NCT01692080</nct_id>
  </id_info>
  <brief_title>Implementation of an Asthma Program to Improve Asthma Identification and Education in Children</brief_title>
  <official_title>Implementation of an Asthma Program to Improve Asthma Identification and Education in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duquesne University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pennsylvania Department of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duquesne University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to document the prevalence and associations between&#xD;
      asthma, hypertension, and obesity in children living in Pittsburgh, Pennsylvania and its&#xD;
      surrounding regions.&#xD;
&#xD;
      The secondary objective is to determine the impact of various educational interventions on&#xD;
      child and caregiver knowledge of asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Asthma Program will consist of six screenings and three camps each year, for two&#xD;
      consecutive years. Screenings will be conducted in areas where populations are known to be at&#xD;
      increased risk for asthma and its complications, such as inner-city, lower socioeconomic,&#xD;
      African-American populations. Screenings will be conducted at churches or schools in these&#xD;
      areas one month prior to each camp in an effort to identify children with undiagnosed or&#xD;
      uncontrolled asthma and refer them to the camps. Camps will also be conducted in areas where&#xD;
      populations are known to be at increased risk for asthma and its complications to improve&#xD;
      ease of access. Asthma and smoking cessation education will be provided at each camp to&#xD;
      children and caregivers. Baseline data will be collected at each camp and assessed.&#xD;
      Longitudinal clinical outcomes will be assessed in children attending multiple camps.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome of this study is to document the prevalence of asthma, hypertension and obesity in children living in Pittsburgh's inner-city.</measure>
    <time_frame>Up to three years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary outcome of this study is to determine the impact of various educational interventions on child and caregiver knowledge of asthma.</measure>
    <time_frame>up to three years</time_frame>
    <description>A pre and post asthma knowledge test will be given to children and caregivers prior to and after participation in the educational session conducted at each asthma camp. A paired sample t-test was used for comparison of pre and post knowledge tests and a p value of less than 0.05 will be considered to indicate a statistically significant difference.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">231</enrollment>
  <condition>Asthma</condition>
  <condition>Hypertension</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Asthma Screenings and Camps</arm_group_label>
    <description>Children, ages 5-17 years who participate in one of the asthma screenings or camps are eligible to participate in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Asthma education</intervention_name>
    <description>Two separate asthma education classes are conducted to target two age groups: 6-10 yrs and 10-15 yrs. With the guidance of pharmacy faculty, student pharmacists develop innovative educational activities directed at three of the most common barriers to proper asthma control: avoidance of asthma triggers; compliance with asthma medications and proper usage of inhalers; and the importance of an asthma action plan. There is a different group of student pharmacists participating in each camp and this allows for variation in educational activities, all reinforcing the same important aspects of optimal asthma management. Students create age-appropriate activities for each group. Parents are required to attend camps with their child and participate in the asthma education sessions.</description>
    <arm_group_label>Asthma Screenings and Camps</arm_group_label>
    <other_name>asthma knowledge intervention</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Two screenings will be held prior to each camp, at two separate locations, for a total of&#xD;
        six screenings per year. Screenings will be held at different locations throughout the city&#xD;
        of Pittsburgh in an effort to increase identification and recruitment for subsequent camps.&#xD;
        All children will be invited to participate in screenings, regardless of participation in&#xD;
        the study. All children, ages 5-17 years, will be included in our study pending informed&#xD;
        consent and assent. Camps will take place three times each year. All children will be&#xD;
        invited to participate in camps, regardless of participation in the study. All children,&#xD;
        ages 5-17 years will be included in our study pending informed consent and assent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children, ages 5- 17 years attending the asthma camps and screenings.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children younger than 5 years of age and adults 18 years of age and older.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer P Elliott, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duquesne University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duquesne University</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15282</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>August 5, 2013</last_update_submitted>
  <last_update_submitted_qc>August 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2013</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>
  <!-- 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/NCT01692080
org study id: DU Protocol #10-11
nct id: NCT01692080
lead sponsor: 
collaborator: 
has dmc: Yes
The primary objective of this study is to document the prevalence and associations between
      asthma, hypertension, and obesity in children living in Pittsburgh, Pennsylvania and its
      surrounding regions.

      The secondary objective is to determine the impact of various educational interventions on
      child and caregiver knowledge of asthma.
The Asthma Program will consist of six screenings and three camps each year, for two
      consecutive years. Screenings will be conducted in areas where populations are known to be at
      increased risk for asthma and its complications, such as inner-city, lower socioeconomic,
      African-American populations. Screenings will be conducted at churches or schools in these
      areas one month prior to each camp in an effort to identify children with undiagnosed or
      uncontrolled asthma and refer them to the camps. Camps will also be conducted in areas where
      populations are known to be at increased risk for asthma and its complications to improve
      ease of access. Asthma and smoking cessation education will be provided at each camp to
      children and caregivers. Baseline data will be collected at each camp and assessed.
      Longitudinal clinical outcomes will be assessed in children attending multiple camps.
observational model: Ecologic or Community
time perspective: Prospective
measure: The primary outcome of this study is to document the prevalence of asthma, hypertension and obesity in children living in Pittsburgh's inner-city.
time frame: Up to three years
measure: The secondary outcome of this study is to determine the impact of various educational interventions on child and caregiver knowledge of asthma.
time frame: up to three years
description: A pre and post asthma knowledge test will be given to children and caregivers prior to and after participation in the educational session conducted at each asthma camp. A paired sample t-test was used for comparison of pre and post knowledge tests and a p value of less than 0.05 will be considered to indicate a statistically significant difference.
arm group label: Asthma Screenings and Camps
description: Children, ages 5-17 years who participate in one of the asthma screenings or camps are eligible to participate in this study.
intervention type: Behavioral
intervention name: Asthma education
description: Two separate asthma education classes are conducted to target two age groups: 6-10 yrs and 10-15 yrs. With the guidance of pharmacy faculty, student pharmacists develop innovative educational activities directed at three of the most common barriers to proper asthma control: avoidance of asthma triggers; compliance with asthma medications and proper usage of inhalers; and the importance of an asthma action plan. There is a different group of student pharmacists participating in each camp and this allows for variation in educational activities, all reinforcing the same important aspects of optimal asthma management. Students create age-appropriate activities for each group. Parents are required to attend camps with their child and participate in the asthma education sessions.
arm group label: Asthma Screenings and Camps
other name: asthma knowledge intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer P Elliott, PharmD
role: Principal Investigator
affiliation: Duquesne University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma