<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/NCT02185391</url>
  </required_header>
  <id_info>
    <org_study_id>ParacelsusHCBS 2013-125</org_study_id>
    <nct_id>NCT02185391</nct_id>
  </id_info>
  <brief_title>Interactive Education of Patients With Coronary Heart Disease</brief_title>
  <acronym>INSERT</acronym>
  <official_title>Development of Sustainable Methods in Interactive Patient Education to Improve Adherence After Cardiac Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paracelsus Harz Clinic Bad Suderode.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The German Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Paracelsus Harz Clinic Bad Suderode.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronary Heart Diseases are responsible for a high number of deaths in Germany. To determine&#xD;
      the risk factors secondary prevention is of great importance. After their residence in&#xD;
      rehabilitation centers patients often get rid of newly required skills. In addition to that&#xD;
      parameters like BMI, blood pressure and cholesterol level return to their initial value.&#xD;
&#xD;
      Using an Audience Response System (ARS) during oral presentations in rehabilitation centers&#xD;
      should improve the learning effect of patients. Furthermore patients will receive motivating&#xD;
      telephone calls in the follow-up. These methods should lead to a sustainable improvement of&#xD;
      learning effects, health care behavior and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Training content as a measure of success</measure>
    <time_frame>3 - 4 weeks</time_frame>
    <description>Reaching a total score (70 points) with respect to the training content as a measure of success of the current interactive patient education</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI and / or abdominal circumference</measure>
    <time_frame>12 months</time_frame>
    <description>Change in BMI and / or abdominal circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Cholesterol Values</measure>
    <time_frame>12 months</time_frame>
    <description>Change in Blood Cholesterol Values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Score</measure>
    <time_frame>12 months</time_frame>
    <description>Change in Depression Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Living</measure>
    <time_frame>12 months</time_frame>
    <description>Change in Health Related Quality of Living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients with a stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial Infarction</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients with Myocardial Infarction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Coronary Disease</condition>
  <arm_group>
    <arm_group_label>fact-finding group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Audience Response System and motivational telephone interview</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Audience Response System</intervention_name>
    <description>patients use during oral presentations an audience response system</description>
    <arm_group_label>fact-finding group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone interview</intervention_name>
    <description>patients receive motivational telephone interviews after their residence in rehabilitation clinics</description>
    <arm_group_label>fact-finding group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or refusal to give written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Paracelsus Harz Clinic Bad Suderode</name>
      <address>
        <city>Quedlinburg</city>
        <state>Saxony-Anhalt</state>
        <zip>06485</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Disease</keyword>
  <keyword>Audience Response System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</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/NCT02185391
org study id: ParacelsusHCBS 2013-125
nct id: NCT02185391
lead sponsor: 
collaborator: 
has dmc: No
Coronary Heart Diseases are responsible for a high number of deaths in Germany. To determine
      the risk factors secondary prevention is of great importance. After their residence in
      rehabilitation centers patients often get rid of newly required skills. In addition to that
      parameters like BMI, blood pressure and cholesterol level return to their initial value.

      Using an Audience Response System (ARS) during oral presentations in rehabilitation centers
      should improve the learning effect of patients. Furthermore patients will receive motivating
      telephone calls in the follow-up. These methods should lead to a sustainable improvement of
      learning effects, health care behavior and quality of life.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Training content as a measure of success
time frame: 3 - 4 weeks
description: Reaching a total score (70 points) with respect to the training content as a measure of success of the current interactive patient education
measure: BMI and / or abdominal circumference
time frame: 12 months
description: Change in BMI and / or abdominal circumference
measure: Blood Cholesterol Values
time frame: 12 months
description: Change in Blood Cholesterol Values
measure: Depression Score
time frame: 12 months
description: Change in Depression Score
measure: Health Related Quality of Living
time frame: 12 months
description: Change in Health Related Quality of Living
measure: Stroke
time frame: 12 months
description: Number of patients with a stroke
measure: Myocardial Infarction
time frame: 12 months
description: Number of patients with Myocardial Infarction
arm group label: fact-finding group
arm group type: Experimental
description: Intervention: Audience Response System and motivational telephone interview
arm group label: control group
arm group type: No Intervention
intervention type: Procedure
intervention name: Audience Response System
description: patients use during oral presentations an audience response system
arm group label: fact-finding group
intervention type: Behavioral
intervention name: Telephone interview
description: patients receive motivational telephone interviews after their residence in rehabilitation clinics
arm group label: fact-finding group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Coronary Disease
mesh term: Coronary Artery Disease