xml: <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/NCT06040294</url>
    </required_header>
    <id_info>
      <org_study_id>YLH-IRB-11210</org_study_id>
      <nct_id>NCT06040294</nct_id>
    </id_info>
    <brief_title>Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills</brief_title>
    <official_title>Evaluation of a Dementia and Disability Simulation Program for Senior Activity Facilitation Skills Among College Nursing Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tzu Chi University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tzu Chi University of Science and Technology</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>
        This study aims to evaluate the effectiveness of a dementia and disability simulation (DDS)&#xD;
        program on dementia knowledge, attitude, empathy, and activity design skills for seniors&#xD;
        among college nursing students.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This two-group randomised controlled trial aims to evaluate the effectiveness of a dementia&#xD;
        and disability simulation program on dementia knowledge, attitude, empathy, and activity&#xD;
        design skills for seniors among college nursing students.&#xD;
  &#xD;
        The interventional group will receive a 6-week dementia and disability simulation program of&#xD;
        activity design for seniors.&#xD;
  &#xD;
        The control group will receive 6 weeks of regular dementia course and group discussion of&#xD;
        activity design for seniors with no dementia and disability simulation.&#xD;
  &#xD;
        Both groups will be assessed for their dementia knowledge, attitude, empathy and activity&#xD;
        design skills for seniors at baseline, week 12, and week 18.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>
      <intervention_model_description>two-group randomised controlled trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dementia Knowledge Assessment Scale (DKAS)</measure>
      <time_frame>Baseline, week 12, week 18</time_frame>
      <description>score of knowledge about dementia (0~50) higher scores indicate more knowledge about dementia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Approaches to Dementia Questionnaire (ADQ)</measure>
      <time_frame>Baseline, week 12, week 18</time_frame>
      <description>score of attitude toward people with dementia (19~95) higher scores indicate more positive attitude towards dementia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Jefferson Scale of Empathy (JSE)</measure>
      <time_frame>Baseline, week 12, week 18</time_frame>
      <description>score of empathy (20~140) higher scores indicate more empathy for people with dementia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rubrics of activity design skills for seniors</measure>
      <time_frame>Baseline, week 12, week 18</time_frame>
      <description>score of activity design skills for seniors (0~45) higher scores indicate better skills of designing activities for seniors</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Dementia</condition>
    <arm_group>
      <arm_group_label>dementia and disability simulation program (DDS)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>DDS program consists of dementia virtual reality and disability simulation of activity design for seniors</description>
    </arm_group>
    <arm_group>
      <arm_group_label>dementia course with no DDS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Regular dementia course and group discussions of activity design for seniors with no DDS</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>DDS program</intervention_name>
      <description>dementia virtual reality and disability simulation of activity design for seniors</description>
      <arm_group_label>dementia and disability simulation program (DDS)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>dementia course with no DDS</intervention_name>
      <description>Regular dementia course and group discussions of activity design for seniors with no DDS</description>
      <arm_group_label>dementia course with no DDS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  college nursing students with age ranged from 19 to 40 years,&#xD;
  &#xD;
            -  Taiwanese nationality,&#xD;
  &#xD;
            -  Sophomore and above&#xD;
  &#xD;
            -  provide informed consent to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -college nursing students who do not meet the inclusion criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Huei-Chuan Sung, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tzu Chi University of Science and Technology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tzu Chi University of Science and Technology</name>
        <address>
          <city>Hualien City</city>
          <zip>970</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tzu Chi University of Science and Technology</investigator_affiliation>
      <investigator_full_name>Huei-Chuan Sung</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>dementia</keyword>
    <keyword>disability</keyword>
    <keyword>simulation</keyword>
    <keyword>nursing student</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040294
  org study id: YLH-IRB-11210
  nct id: NCT06040294
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the effectiveness of a dementia and disability simulation (DDS)
        program on dementia knowledge, attitude, empathy, and activity design skills for seniors
        among college nursing students.
  This two-group randomised controlled trial aims to evaluate the effectiveness of a dementia
        and disability simulation program on dementia knowledge, attitude, empathy, and activity
        design skills for seniors among college nursing students.
  
        The interventional group will receive a 6-week dementia and disability simulation program of
        activity design for seniors.
  
        The control group will receive 6 weeks of regular dementia course and group discussion of
        activity design for seniors with no dementia and disability simulation.
  
        Both groups will be assessed for their dementia knowledge, attitude, empathy and activity
        design skills for seniors at baseline, week 12, and week 18.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: two-group randomised controlled trial
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Dementia Knowledge Assessment Scale (DKAS)
  time frame: Baseline, week 12, week 18
  description: score of knowledge about dementia (0~50) higher scores indicate more knowledge about dementia
  measure: Approaches to Dementia Questionnaire (ADQ)
  time frame: Baseline, week 12, week 18
  description: score of attitude toward people with dementia (19~95) higher scores indicate more positive attitude towards dementia
  measure: Jefferson Scale of Empathy (JSE)
  time frame: Baseline, week 12, week 18
  description: score of empathy (20~140) higher scores indicate more empathy for people with dementia
  measure: Rubrics of activity design skills for seniors
  time frame: Baseline, week 12, week 18
  description: score of activity design skills for seniors (0~45) higher scores indicate better skills of designing activities for seniors
  arm group label: dementia and disability simulation program (DDS)
  arm group type: Experimental
  description: DDS program consists of dementia virtual reality and disability simulation of activity design for seniors
  arm group label: dementia course with no DDS
  arm group type: Active Comparator
  description: Regular dementia course and group discussions of activity design for seniors with no DDS
  intervention type: Other
  intervention name: DDS program
  description: dementia virtual reality and disability simulation of activity design for seniors
  arm group label: dementia and disability simulation program (DDS)
  intervention type: Other
  intervention name: dementia course with no DDS
  description: Regular dementia course and group discussions of activity design for seniors with no DDS
  arm group label: dementia course with no DDS
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Huei-Chuan Sung, PhD
  role: Principal Investigator
  affiliation: Tzu Chi University of Science and Technology
  facility: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Tzu Chi University of Science and Technology
  investigator full name: Huei-Chuan Sung
  investigator title: Associate professor
  mesh term: Dementia