<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/NCT02978352</url>
  </required_header>
  <id_info>
    <org_study_id>300/2559(EC4)</org_study_id>
    <nct_id>NCT02978352</nct_id>
  </id_info>
  <brief_title>A Comparison of Learning Method (CAM-ICU) Between E-learning and Conventional Face-to-face Lecture and Demonstration</brief_title>
  <official_title>A Comparison of Learning Effectiveness of Confusion Assessment Method (CAM-ICU) Between E-learning and Conventional Face-to-face Lecture and Demonstration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced&#xD;
      attention, impaired cognition and perception, usually resulting from general physical&#xD;
      conditions. Delirium contributes to longer hospital length of stay, increased mortality,&#xD;
      increased healthcare costs, and long-term cognitive and functional impairment. However, it is&#xD;
      often underdiagnosed and undertreated. E-learning (electronic learning) proves to be a&#xD;
      time-efficient, flexible and convenient training method, making it suitable for a large&#xD;
      organization like Siriraj hospital where there is a large employee turnover rate. So the&#xD;
      investigators want to compare the passing rate between the e-learning group and the&#xD;
      traditional learning group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective: Compare the passing rate between the e-learning group and the traditional&#xD;
      learning group&#xD;
&#xD;
      Secondary objectives: Assess the trainees' satisfaction and problems associated with&#xD;
      e-learning implementation, Investigate the causes of inaccurate CAM-ICU assessment for&#xD;
      improvement in future training sessions&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The passing rate between the e-learning group and the traditional learning group</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the trainees' satisfaction</measure>
    <time_frame>2 weeks</time_frame>
    <description>Satisfaction score from 0 (dissatisfy) and 10 (very satisfy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigate the causes of inaccurate CAM-ICU assessment for improvement in future training sessions</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>face-to-face</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traditional learning group (face-to-face): 4 different sessions will be conducted to suit the participants' convenience Duration of each session is 60-90 minutes Each session comprises lecture, video demonstration of CAM-ICU assessment, discussion, volunteer participation during class demonstration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-learning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60-90 minute online course will be accessible through intranet Wi-Fi The course encompasses types, incidence, risk factors, significance and effects of delirium, diagnostic criteria and CAM-ICU application Inclusion of video demonstration of simulated patients and CAM-ICU application, common pitfalls of healthcare providers, and practice questions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>learning</intervention_name>
    <arm_group_label>E-learning</arm_group_label>
    <arm_group_label>face-to-face</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU nurse&#xD;
&#xD;
          -  general ward nurse&#xD;
&#xD;
          -  private ward nurses&#xD;
&#xD;
          -  nurse anesthetists&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous exposure to CAM-ICU&#xD;
&#xD;
          -  Inability to complete the training courses&#xD;
&#xD;
          -  Inability to complete the required 3 simulated patient scenarios&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>June 22, 2017</last_update_submitted>
  <last_update_submitted_qc>June 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 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>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02978352
org study id: 300/2559(EC4)
nct id: NCT02978352
lead sponsor: 
has dmc: No
Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced
      attention, impaired cognition and perception, usually resulting from general physical
      conditions. Delirium contributes to longer hospital length of stay, increased mortality,
      increased healthcare costs, and long-term cognitive and functional impairment. However, it is
      often underdiagnosed and undertreated. E-learning (electronic learning) proves to be a
      time-efficient, flexible and convenient training method, making it suitable for a large
      organization like Siriraj hospital where there is a large employee turnover rate. So the
      investigators want to compare the passing rate between the e-learning group and the
      traditional learning group.
Primary objective: Compare the passing rate between the e-learning group and the traditional
      learning group

      Secondary objectives: Assess the trainees' satisfaction and problems associated with
      e-learning implementation, Investigate the causes of inaccurate CAM-ICU assessment for
      improvement in future training sessions
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: The passing rate between the e-learning group and the traditional learning group
time frame: 2 weeks
measure: Assess the trainees' satisfaction
time frame: 2 weeks
description: Satisfaction score from 0 (dissatisfy) and 10 (very satisfy)
measure: Investigate the causes of inaccurate CAM-ICU assessment for improvement in future training sessions
time frame: 2 weeks
arm group label: face-to-face
arm group type: Experimental
description: Traditional learning group (face-to-face): 4 different sessions will be conducted to suit the participants' convenience Duration of each session is 60-90 minutes Each session comprises lecture, video demonstration of CAM-ICU assessment, discussion, volunteer participation during class demonstration
arm group label: E-learning
arm group type: Experimental
description: 60-90 minute online course will be accessible through intranet Wi-Fi The course encompasses types, incidence, risk factors, significance and effects of delirium, diagnostic criteria and CAM-ICU application Inclusion of video demonstration of simulated patients and CAM-ICU application, common pitfalls of healthcare providers, and practice questions
intervention type: Other
intervention name: learning
arm group label: E-learning
arm group label: face-to-face
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Delirium
sharing ipd: No