<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/NCT03266263</url>
  </required_header>
  <id_info>
    <org_study_id>201606085RIND</org_study_id>
    <nct_id>NCT03266263</nct_id>
  </id_info>
  <brief_title>A Study of Improving Education of Community Chain of Survival</brief_title>
  <official_title>Improving Education of Community Chain of Survival Through Innovative Teaching, Implementing Teamwork Skills, and Survey on Attitude and Willingness: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;High-quality cardiopulmonary resuscitation (CPR)&quot; and &quot;early defibrillation&quot; are the most&#xD;
      important parts of &quot;the chain of survival&quot;, and they are highly associated with the survival&#xD;
      rate and life quality of patients with cardiac arrest. It needs the witness to perform&#xD;
      bystander CPR and use the automated external defibrillator (AED) if CPR and defibrillation&#xD;
      are expected to be performed earlier. Nevertheless, few patients with cardiac arrest received&#xD;
      bystander CPR in Taiwan. It might be caused by some reasons. First, traditional training&#xD;
      programs were inefficient and ineffective in the retention of skills and thus students were&#xD;
      not confident in their CPR skills after receiving training programs. Second, the current&#xD;
      training module focused on personal skill training only and lacked teamwork skills training.&#xD;
      It led to poor performance of the students in actual resuscitation scene, where on-scene&#xD;
      resuscitators were usually more than one. Third, the current training contents did not&#xD;
      improve the attitudes and willingness of performing bystander CPR and it caused people who&#xD;
      had received training program did not resuscitate the patients finally. To improve the&#xD;
      above-mentioned problem, a three-year research project will be implemented. The aims of the&#xD;
      project are the following:&#xD;
&#xD;
        1. to explore the effect of different teaching contents and hand-on practice feedback&#xD;
           methods on the students' performance of chest compressing, ventilating and using AED in&#xD;
           the CPR and AED training courses.&#xD;
&#xD;
        2. to analyze the current situation of teamwork when CPR and AED were performed, to build&#xD;
           up the collaborating module accordingly and evaluate the effect of the new module on the&#xD;
           students' performance of chest compressing, ventilating and using AED after the module&#xD;
           is introduced into the training course.&#xD;
&#xD;
        3. to understand the factors affecting the motivations and willingness of people to learn&#xD;
           and practice CPR and AED by utilizing questionnaires, and then to evaluate the effect of&#xD;
           the creative program, which was modified according to the results of the questionnaires,&#xD;
           on the motivations and willingness of people to learn and practice CPR and AED.&#xD;
&#xD;
      The investigators expect to design a more efficient resuscitation skill training course by&#xD;
      implementing the research project and further to improve the motivations and willingness of&#xD;
      people to learn and practice CPR and AED in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Anticipated">July 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2019</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>chest compression rate</measure>
    <time_frame>immediately after the training course</time_frame>
    <description>differences of chest compression rates</description>
  </primary_outcome>
  <primary_outcome>
    <measure>chest compression depth</measure>
    <time_frame>immediately after the training course</time_frame>
    <description>differences of chest compression depth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hands-off time of chest compression</measure>
    <time_frame>immediately after the training course</time_frame>
    <description>differences of hands-off time of chest compression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>score of checklist</measure>
    <time_frame>immediately after the training course</time_frame>
    <description>differences of scores of checklists</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>score of satisfaction questionnaire</measure>
    <time_frame>immediately after the training course</time_frame>
    <description>differences of scores of satisfaction questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiac Arrest Circulatory</condition>
  <arm_group>
    <arm_group_label>automatic computer-led feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>automated feedback for CPR quality provided by computers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>instructor-led feedback</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>feedback for CPR quality provided by instructors</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>automatic computer-led feedback</intervention_name>
    <description>automated feedback software for CPR quality, including compression depth, rate, recoil, hands-off time, and ventilation volume</description>
    <arm_group_label>automatic computer-led feedback</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>instructor-led feedback</intervention_name>
    <description>feedback for CPR quality by instructors</description>
    <arm_group_label>instructor-led feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy laypersons without CPR training within two years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chih-Wei Yang</last_name>
    <phone>886-23123456</phone>
    <phone_ext>61426</phone_ext>
    <email>cwyang0413@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>NTUH</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chih-Wei Yang</last_name>
      <phone>886-23123456</phone>
      <phone_ext>61426</phone_ext>
      <email>cwyang0413@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 27, 2017</last_update_submitted>
  <last_update_submitted_qc>August 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</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>Heart Arrest</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/NCT03266263
org study id: 201606085RIND
nct id: NCT03266263
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
"High-quality cardiopulmonary resuscitation (CPR)" and "early defibrillation" are the most
      important parts of "the chain of survival", and they are highly associated with the survival
      rate and life quality of patients with cardiac arrest. It needs the witness to perform
      bystander CPR and use the automated external defibrillator (AED) if CPR and defibrillation
      are expected to be performed earlier. Nevertheless, few patients with cardiac arrest received
      bystander CPR in Taiwan. It might be caused by some reasons. First, traditional training
      programs were inefficient and ineffective in the retention of skills and thus students were
      not confident in their CPR skills after receiving training programs. Second, the current
      training module focused on personal skill training only and lacked teamwork skills training.
      It led to poor performance of the students in actual resuscitation scene, where on-scene
      resuscitators were usually more than one. Third, the current training contents did not
      improve the attitudes and willingness of performing bystander CPR and it caused people who
      had received training program did not resuscitate the patients finally. To improve the
      above-mentioned problem, a three-year research project will be implemented. The aims of the
      project are the following:

        1. to explore the effect of different teaching contents and hand-on practice feedback
           methods on the students' performance of chest compressing, ventilating and using AED in
           the CPR and AED training courses.

        2. to analyze the current situation of teamwork when CPR and AED were performed, to build
           up the collaborating module accordingly and evaluate the effect of the new module on the
           students' performance of chest compressing, ventilating and using AED after the module
           is introduced into the training course.

        3. to understand the factors affecting the motivations and willingness of people to learn
           and practice CPR and AED by utilizing questionnaires, and then to evaluate the effect of
           the creative program, which was modified according to the results of the questionnaires,
           on the motivations and willingness of people to learn and practice CPR and AED.

      The investigators expect to design a more efficient resuscitation skill training course by
      implementing the research project and further to improve the motivations and willingness of
      people to learn and practice CPR and AED in the future.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: chest compression rate
time frame: immediately after the training course
description: differences of chest compression rates
measure: chest compression depth
time frame: immediately after the training course
description: differences of chest compression depth
measure: hands-off time of chest compression
time frame: immediately after the training course
description: differences of hands-off time of chest compression
measure: score of checklist
time frame: immediately after the training course
description: differences of scores of checklists
measure: score of satisfaction questionnaire
time frame: immediately after the training course
description: differences of scores of satisfaction questionnaire
arm group label: automatic computer-led feedback
arm group type: Experimental
description: automated feedback for CPR quality provided by computers
arm group label: instructor-led feedback
arm group type: Active Comparator
description: feedback for CPR quality provided by instructors
intervention type: Device
intervention name: automatic computer-led feedback
description: automated feedback software for CPR quality, including compression depth, rate, recoil, hands-off time, and ventilation volume
arm group label: automatic computer-led feedback
intervention type: Other
intervention name: instructor-led feedback
description: feedback for CPR quality by instructors
arm group label: instructor-led feedback
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chih-Wei Yang
phone: 886-23123456
phone ext: 61426
email: cwyang0413@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Heart Arrest