<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/NCT01708070</url>
  </required_header>
  <id_info>
    <org_study_id>HL 098240</org_study_id>
    <nct_id>NCT01708070</nct_id>
  </id_info>
  <brief_title>Trial of Asthma Self-Management Education in Patients With Depressive Symptoms</brief_title>
  <official_title>Trial of Asthma Self-Management Education in Patients With Depressive Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although depressive and anxious symptoms are common in asthma patients and are associated&#xD;
      with worse clinical and resource utilization outcomes, there have been no studies focusing on&#xD;
      the particular challenges of improving asthma self-management in this population. The&#xD;
      investigators hypothesize that a tailored intervention to improve asthma self-management in&#xD;
      patients with a known history of depressive and anxious symptoms will be effective in&#xD;
      improving asthma-related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depressive and anxious conditions are common during the lifetime of asthma patients and have&#xD;
      been shown to be associated with worse asthma as defined by more symptoms, more&#xD;
      hospitalizations and greater use of medications. There have been few studies trying to&#xD;
      improve asthma outcomes in patients with known depression. One method to improve outcomes is&#xD;
      to instruct patients in ways to better self manage asthma. The goal of this study is to test&#xD;
      a comprehensive intervention to improve asthma self-management by increasing knowledge and&#xD;
      self-efficacy in patients with a known history of a positive screen for depression. Patients&#xD;
      will be randomized to two groups - a control group and an intervention group. Patients in the&#xD;
      control group will receive an asthma workbook, will make a contract to adopt behaviors they&#xD;
      think will improve asthma, and will receive telephone follow-ups approximately every week for&#xD;
      8 weeks and then approximately every 2 months. Patients in the intervention group will&#xD;
      receive these components plus they will be taught how to use a peak flow meter and specific&#xD;
      chapters of the workbook will be used as templates for focused instruction during telephone&#xD;
      follow-ups. The primary outcome will be a comparison of within-patient change in&#xD;
      asthma-related quality of life between groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in asthma-related quality of life</measure>
    <time_frame>Approximately 12 months</time_frame>
    <description>The primary outcome will be a comparison of within-patient change in Asthma Quality of Life Questionnaire scores between groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of urgent resource utilization visits for asthma</measure>
    <time_frame>Approximately 12 months</time_frame>
    <description>An additional outcome will be the comparison of the number or urgent resource utilization visits for asthma.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Severity of depressive symptoms</measure>
    <time_frame>Approximately 12 months</time_frame>
    <description>We will characterize and monitor the severity of depressive symptoms during the trial using standardized scales.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Asthma</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Asthma self-management experimental</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention will involve a self-management workbook, contracting to improve self-management behaviors, instruction in using of a peak flow meter, and follow-up discussions based on the workbook.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asthma self-management control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control state will involve a self-management workbook and contracting to improve self-management behaviors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Asthma self-management</intervention_name>
    <description>Patients in the intervention group will receive an asthma workbook, will make a contract to adopt behaviors they think will improve asthma, will be taught how to use a peak flow meter and specific chapters of the workbook will be used as templates for focused instruction during telephone follow-ups which will occur every week for 8 weeks and then approximately every 2 months.</description>
    <arm_group_label>Asthma self-management control</arm_group_label>
    <arm_group_label>Asthma self-management experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  known history of depressive or anxious symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  has cognitive deficits&#xD;
&#xD;
          -  no access to telephone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol A Mancuso, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Internal Medicine Associates/Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>September 9, 2016</last_update_submitted>
  <last_update_submitted_qc>September 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Depression</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/NCT01708070
org study id: HL 098240
nct id: NCT01708070
lead sponsor: 
has dmc: Yes
Although depressive and anxious symptoms are common in asthma patients and are associated
      with worse clinical and resource utilization outcomes, there have been no studies focusing on
      the particular challenges of improving asthma self-management in this population. The
      investigators hypothesize that a tailored intervention to improve asthma self-management in
      patients with a known history of depressive and anxious symptoms will be effective in
      improving asthma-related quality of life.
Depressive and anxious conditions are common during the lifetime of asthma patients and have
      been shown to be associated with worse asthma as defined by more symptoms, more
      hospitalizations and greater use of medications. There have been few studies trying to
      improve asthma outcomes in patients with known depression. One method to improve outcomes is
      to instruct patients in ways to better self manage asthma. The goal of this study is to test
      a comprehensive intervention to improve asthma self-management by increasing knowledge and
      self-efficacy in patients with a known history of a positive screen for depression. Patients
      will be randomized to two groups - a control group and an intervention group. Patients in the
      control group will receive an asthma workbook, will make a contract to adopt behaviors they
      think will improve asthma, and will receive telephone follow-ups approximately every week for
      8 weeks and then approximately every 2 months. Patients in the intervention group will
      receive these components plus they will be taught how to use a peak flow meter and specific
      chapters of the workbook will be used as templates for focused instruction during telephone
      follow-ups. The primary outcome will be a comparison of within-patient change in
      asthma-related quality of life between groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Change in asthma-related quality of life
time frame: Approximately 12 months
description: The primary outcome will be a comparison of within-patient change in Asthma Quality of Life Questionnaire scores between groups.
measure: Number of urgent resource utilization visits for asthma
time frame: Approximately 12 months
description: An additional outcome will be the comparison of the number or urgent resource utilization visits for asthma.
measure: Severity of depressive symptoms
time frame: Approximately 12 months
description: We will characterize and monitor the severity of depressive symptoms during the trial using standardized scales.
arm group label: Asthma self-management experimental
arm group type: Active Comparator
description: The intervention will involve a self-management workbook, contracting to improve self-management behaviors, instruction in using of a peak flow meter, and follow-up discussions based on the workbook.
arm group label: Asthma self-management control
arm group type: Other
description: The control state will involve a self-management workbook and contracting to improve self-management behaviors.
intervention type: Behavioral
intervention name: Asthma self-management
description: Patients in the intervention group will receive an asthma workbook, will make a contract to adopt behaviors they think will improve asthma, will be taught how to use a peak flow meter and specific chapters of the workbook will be used as templates for focused instruction during telephone follow-ups which will occur every week for 8 weeks and then approximately every 2 months.
arm group label: Asthma self-management control
arm group label: Asthma self-management experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Carol A Mancuso, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
mesh term: Depression