<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/NCT03302962</url>
  </required_header>
  <id_info>
    <org_study_id>1U54MD008164-01</org_study_id>
    <nct_id>NCT03302962</nct_id>
  </id_info>
  <brief_title>Factors Influencing Pediatric Asthma</brief_title>
  <acronym>FIPA</acronym>
  <official_title>Factors Influencing Pediatric Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Missouri Breaks Industries Research, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanford Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Missouri Breaks Industries Research, Inc.</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>
      Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple&#xD;
      physiologic, environmental and social conditions impact the prevalence and severity of&#xD;
      asthma. Even when diagnosed, effective control can be impeded by improper use of medication,&#xD;
      not understanding or being unable to avoid environmental triggers, lack of continuity in&#xD;
      follow-up care, and lack of an asthma action plan. American Indians are especially at-risk&#xD;
      for health problems related to asthma. American Indians have the highest asthma rate among&#xD;
      single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are&#xD;
      diagnosed with asthma in the general population but little is known about why this is true.&#xD;
      Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial&#xD;
      influences on disease and this study investigated the possible improvement in asthma control&#xD;
      from an intensive educational intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study was to test the hypothesis that intensive patient education&#xD;
      regarding self-directed, stepped care will result in reduced morbidity and medical care&#xD;
      utilization, while increasing quality of life.&#xD;
&#xD;
      One half (54) of the identified cases will be randomized to receive the previously&#xD;
      established &quot;BREATHE&quot; study educational program, emphasizing patient-centered, self&#xD;
      management of asthma. Periodic follow-up through personal contact and surveillance of IHS&#xD;
      RPMS or other medical provider records was conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2013</start_date>
  <completion_date type="Actual">May 25, 2017</completion_date>
  <primary_completion_date type="Actual">May 25, 2017</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>Chart Review of ED Visits</measure>
    <time_frame>3 years</time_frame>
    <description>Emergency room visits for pulmonary complaints</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">324</enrollment>
  <condition>Asthma in Children</condition>
  <arm_group>
    <arm_group_label>Intensive Asthma Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One half (54) of the identified cases were randomized to receive the previously established &quot;BREATHE&quot; study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Asthma Education Literature</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The remaining 54 cases were randomized to the &quot;control&quot; arm and received written materials related to patient-centered asthma control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive Asthma Education</intervention_name>
    <description>One half (54) of the identified cases were randomized to receive the previously established &quot;BREATHE&quot; study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.</description>
    <arm_group_label>Intensive Asthma Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cases must be &quot;American Indian&quot; (eligibile for care within the Indian Health Service);&#xD;
             and at least 2 of the following 3 criteria:&#xD;
&#xD;
               1. a diagnosis of asthma on at least 2 occasions by more than one provider during&#xD;
                  the past 2 years.&#xD;
&#xD;
               2. refills of asthma treatment medications on at least 2 occasions during the past 2&#xD;
                  years.&#xD;
&#xD;
               3. Improvement of spirometry FEV1 of 20% with use of albuterol MDI or nebulizer.&#xD;
&#xD;
          -  Controls meet the same demographic criteria as cases, but must also meet all of the&#xD;
             following criteria.&#xD;
&#xD;
               1. No diagnosis of asthma by any provider during the past 2 years.&#xD;
&#xD;
               2. No prescriptions of any asthma meds during the past 2 years.&#xD;
&#xD;
               3. FEV1 on spirometry greater than 80% of predicted value Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Birthweight less than 2500 grams&#xD;
&#xD;
          2. Neonatal ventilator treatment&#xD;
&#xD;
          3. Hospitalization at birth greater than 15 days.&#xD;
&#xD;
          4. Congenital heart anomaly requiring surgery&#xD;
&#xD;
          5. Diagnosis of cystic fibrosis&#xD;
&#xD;
          6. Congenital lung, diaphragm, chest wall, or airway anomaly&#xD;
&#xD;
          7. Diagnosis of pneumonia, pertussis, or tuberculosis within the past year&#xD;
&#xD;
          8. Congenital muscular disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Missouri Breaks Industries Research Inc.</name>
      <address>
        <city>Eagle Butte</city>
        <state>South Dakota</state>
        <zip>57625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>pediatric</keyword>
  <keyword>american indian</keyword>
  <keyword>children</keyword>
  <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>
    <ipd_description>This study was conducted by permission of the Cheyenne River Sioux Tribe and data sharing is allowed only with their permission. Any investigators wishing to access data from the study should contact Missouri Breaks Industries Research Inc for information on application procedures.</ipd_description>
  </patient_data>
  <!-- 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/NCT03302962
org study id: 1U54MD008164-01
nct id: NCT03302962
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple
      physiologic, environmental and social conditions impact the prevalence and severity of
      asthma. Even when diagnosed, effective control can be impeded by improper use of medication,
      not understanding or being unable to avoid environmental triggers, lack of continuity in
      follow-up care, and lack of an asthma action plan. American Indians are especially at-risk
      for health problems related to asthma. American Indians have the highest asthma rate among
      single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are
      diagnosed with asthma in the general population but little is known about why this is true.
      Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial
      influences on disease and this study investigated the possible improvement in asthma control
      from an intensive educational intervention.
The primary aim of this study was to test the hypothesis that intensive patient education
      regarding self-directed, stepped care will result in reduced morbidity and medical care
      utilization, while increasing quality of life.

      One half (54) of the identified cases will be randomized to receive the previously
      established "BREATHE" study educational program, emphasizing patient-centered, self
      management of asthma. Periodic follow-up through personal contact and surveillance of IHS
      RPMS or other medical provider records was conducted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Chart Review of ED Visits
time frame: 3 years
description: Emergency room visits for pulmonary complaints
arm group label: Intensive Asthma Education
arm group type: Experimental
description: One half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.
arm group label: Routine Asthma Education Literature
arm group type: No Intervention
description: The remaining 54 cases were randomized to the "control" arm and received written materials related to patient-centered asthma control.
intervention type: Behavioral
intervention name: Intensive Asthma Education
description: One half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.
arm group label: Intensive Asthma Education
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No
ipd description: This study was conducted by permission of the Cheyenne River Sioux Tribe and data sharing is allowed only with their permission. Any investigators wishing to access data from the study should contact Missouri Breaks Industries Research Inc for information on application procedures.