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/NCT06032351</url>
    </required_header>
    <id_info>
      <org_study_id>NSTC 112-2410-H-255 -006 -MY2</org_study_id>
      <secondary_id>NMRPF3N0081</secondary_id>
      <nct_id>NCT06032351</nct_id>
    </id_info>
    <brief_title>Construction and Validation of Dementia Care Management Competency</brief_title>
    <official_title>Construction and Validation of Dementia Care Management Competency: From Curriculum Integration to Outcome Evaluation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chang Gung Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Science and Technology Council</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chang Gung University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Chang Gung Memorial 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>
        This study will use the concept of competency-based education to develop an innovative&#xD;
        integrated curriculum with EPAs to guide learning and assessment of competency performance to&#xD;
        equip students with dementia care management competency and cultivate professionals to meet&#xD;
        the social trends and practical needs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will use the concept of competency-based education to develop an innovative&#xD;
        integrated curriculum with EPAs to guide learning and assessment of competency performance to&#xD;
        equip students with dementia care management competency and cultivate professionals to meet&#xD;
        the social trends and practical needs. The first year is a preparation period for the&#xD;
        development of the project, which focuses on developing research tools and teacher&#xD;
        empowerment, and evaluating the effectiveness of the control group in implementing&#xD;
        conventional teaching methods. The second year is the program testing, implementation and&#xD;
        evaluation period, in which two phases of the intervention is conducted and the&#xD;
        post-intervention phase of competency is evaluated. This study is expected to establish a&#xD;
        competency-based innovative and integrated curriculum for dementia care management over a&#xD;
        two-year period. The results of the study will be used as a reference for schools or&#xD;
        practices in the development of competency-based curriculum integration.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Demographic data of student</measure>
      <time_frame>The investigators will collect demographic data of students on the day before the start date of the intervention.</time_frame>
      <description>Include age, gender, education level, areas of studying, etc.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dementia Care Professional Competency Assessment Scale</measure>
      <time_frame>T0(Baseline), T1(Immediately after the intervention), T2(3 months after the intervention).</time_frame>
      <description>The scale was developed by our past research that was supported by the Taiwan Ministry of Science and Technology (Grant Number 106-2511-S-255-002-MY3). The scale is used to evaluate dementia care competency in students (Huang et al., 2018).&#xD;
  This Scale contains nine subscales (74 items), using Likert 5-point Likert scale from 1 to 5. A higher score means better competencies.&#xD;
  This scale is used to evaluate the competence of students.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Problem solving, Teamwork Competency Assessment Scale</measure>
      <time_frame>T0(Baseline), T1(Immediately after the intervention), T2(3 months after the intervention).</time_frame>
      <description>The scale was developed by our past research that was supported by the Taiwan Ministry of Science and Technology (Grant Number 106-2511-S-255-002-MY3). There are 22 questions on this scale. The scale is used to evaluate the problem-solving and teamwork competency of students. (Huang et al. 2018).&#xD;
  This scale contains 22 items.10 items were used to evaluate problem-solving competencies, 12 items were used to evaluate teamwork competencies. A higher score means better competencies.&#xD;
  This scale is used to evaluate the competence of students. Change from Baseline problem-solving and teamwork competency at the end of the semester, and after students finish the clinical practice course.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Learning Satisfaction Scale</measure>
      <time_frame>Immediately after the intervention.</time_frame>
      <description>The scale was developed by our past research that was supported by the Taiwan Ministry of Science and Technology (Grant Number 106-2511-S-255-002-MY3). There are 9 questions on this scale. The scale is used to evaluate the learning satisfaction of students. (Huang et al. 2018).&#xD;
  This Scale contains 9 items, using Likert 5-point Likert scale from 1 to 5. A higher score means high learning satisfaction.&#xD;
  This scale is used to evaluate the learning satisfaction of students.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Performance in a summative OSCE test (OSCE scores)</measure>
      <time_frame>Immediately after the intervention.</time_frame>
      <description>Conduct Objective Structured Clinical Examination&#xD;
  After the intervention, the study sample participated in the final OSCE exam. Their scores were compared. The minimum value was 0 while the maximum value was 100. The higher the score the better students had performed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Qualitative interview</measure>
      <time_frame>The investigators will conduct qualitative interviews using focus groups 3 months after the intervention.</time_frame>
      <description>Conduct qualitative interviews with the curriculum integration group students, focusing on the effectiveness of the curriculum integration.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">190</enrollment>
    <condition>Dementia</condition>
    <arm_group>
      <arm_group_label>conventional teaching group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>conventional teaching methods</description>
    </arm_group>
    <arm_group>
      <arm_group_label>curriculum integration Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The curriculum integration group will receive two intervention phases, including an innovation-integrated curriculum for dementia care and an innovation-integrated curriculum for care management with Entrustable Professional Activities (EPAs) to guide learning and assessment of competency performance to equip students with dementia care management competency.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Innovation-integrated curriculum for dementia care and care management</intervention_name>
      <description>The curriculum integration group will receive two intervention phases, including an innovation-integrated curriculum for dementia care and an innovation-integrated curriculum for care management with Entrustable Professional Activities (EPAs), lectures, Situated Simulation Learning, Team-based learning, and Objective Structured Clinical Examination(OSCE).</description>
      <arm_group_label>curriculum integration Group</arm_group_label>
      <other_name>experimental group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional classroom teaching course programs</intervention_name>
      <description>The conventional teaching group will receive only traditional classroom teaching course programs.</description>
      <arm_group_label>conventional teaching group</arm_group_label>
      <other_name>Control Group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1)Be at least 20 years old.&#xD;
  &#xD;
               (2)The students are freshmen majoring in the Department of Gerontology and Health Care&#xD;
               Management, and taking the course on Dementia care.&#xD;
  &#xD;
               (3)Before taking the course on Dementia care, have taken courses on basic geriatric&#xD;
               nursing.&#xD;
  &#xD;
               (4)voluntary participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The students who suspension of schooling.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Huei-Ling Huang, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Chang Gung University of Science and Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Huei-Ling Huang, PhD</last_name>
      <phone>+886-3-2118999</phone>
      <phone_ext>5803</phone_ext>
      <email>hlhuang@gw.cgust.edu.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chang Gung University of Science and Technology</name>
        <address>
          <city>Taoyuan</city>
          <zip>333</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
      <investigator_full_name>Huei-Ling Huang</investigator_full_name>
      <investigator_title>Associate Professor, PhD, RN, Department of Gerontology and Health Care Management, College of Nursing, Chang Gung University of Science and Technology, Taoyuan, Taiwan, R.O.C</investigator_title>
    </responsible_party>
    <keyword>Teaching Method</keyword>
    <keyword>Medical Practice Management</keyword>
    <keyword>Competence</keyword>
    <keyword>Competency-Based Education</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/NCT06032351
  org study id: NSTC 112-2410-H-255 -006 -MY2
  secondary id: NMRPF3N0081
  nct id: NCT06032351
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will use the concept of competency-based education to develop an innovative
        integrated curriculum with EPAs to guide learning and assessment of competency performance to
        equip students with dementia care management competency and cultivate professionals to meet
        the social trends and practical needs.
  This study will use the concept of competency-based education to develop an innovative
        integrated curriculum with EPAs to guide learning and assessment of competency performance to
        equip students with dementia care management competency and cultivate professionals to meet
        the social trends and practical needs. The first year is a preparation period for the
        development of the project, which focuses on developing research tools and teacher
        empowerment, and evaluating the effectiveness of the control group in implementing
        conventional teaching methods. The second year is the program testing, implementation and
        evaluation period, in which two phases of the intervention is conducted and the
        post-intervention phase of competency is evaluated. This study is expected to establish a
        competency-based innovative and integrated curriculum for dementia care management over a
        two-year period. The results of the study will be used as a reference for schools or
        practices in the development of competency-based curriculum integration.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Demographic data of student
  time frame: The investigators will collect demographic data of students on the day before the start date of the intervention.
  description: Include age, gender, education level, areas of studying, etc.
  measure: Dementia Care Professional Competency Assessment Scale
  time frame: T0(Baseline), T1(Immediately after the intervention), T2(3 months after the intervention).
  description: The scale was developed by our past research that was supported by the Taiwan Ministry of Science and Technology (Grant Number 106-2511-S-255-002-MY3). The scale is used to evaluate dementia care competency in students (Huang et al., 2018).
  This Scale contains nine subscales (74 items), using Likert 5-point Likert scale from 1 to 5. A higher score means better competencies.
  This scale is used to evaluate the competence of students.
  measure: Problem solving, Teamwork Competency Assessment Scale
  time frame: T0(Baseline), T1(Immediately after the intervention), T2(3 months after the intervention).
  description: The scale was developed by our past research that was supported by the Taiwan Ministry of Science and Technology (Grant Number 106-2511-S-255-002-MY3). There are 22 questions on this scale. The scale is used to evaluate the problem-solving and teamwork competency of students. (Huang et al. 2018).
  This scale contains 22 items.10 items were used to evaluate problem-solving competencies, 12 items were used to evaluate teamwork competencies. A higher score means better competencies.
  This scale is used to evaluate the competence of students. Change from Baseline problem-solving and teamwork competency at the end of the semester, and after students finish the clinical practice course.
  measure: Learning Satisfaction Scale
  time frame: Immediately after the intervention.
  description: The scale was developed by our past research that was supported by the Taiwan Ministry of Science and Technology (Grant Number 106-2511-S-255-002-MY3). There are 9 questions on this scale. The scale is used to evaluate the learning satisfaction of students. (Huang et al. 2018).
  This Scale contains 9 items, using Likert 5-point Likert scale from 1 to 5. A higher score means high learning satisfaction.
  This scale is used to evaluate the learning satisfaction of students.
  measure: Performance in a summative OSCE test (OSCE scores)
  time frame: Immediately after the intervention.
  description: Conduct Objective Structured Clinical Examination
  After the intervention, the study sample participated in the final OSCE exam. Their scores were compared. The minimum value was 0 while the maximum value was 100. The higher the score the better students had performed.
  measure: Qualitative interview
  time frame: The investigators will conduct qualitative interviews using focus groups 3 months after the intervention.
  description: Conduct qualitative interviews with the curriculum integration group students, focusing on the effectiveness of the curriculum integration.
  arm group label: conventional teaching group
  arm group type: Other
  description: conventional teaching methods
  arm group label: curriculum integration Group
  arm group type: Experimental
  description: The curriculum integration group will receive two intervention phases, including an innovation-integrated curriculum for dementia care and an innovation-integrated curriculum for care management with Entrustable Professional Activities (EPAs) to guide learning and assessment of competency performance to equip students with dementia care management competency.
  intervention type: Other
  intervention name: Innovation-integrated curriculum for dementia care and care management
  description: The curriculum integration group will receive two intervention phases, including an innovation-integrated curriculum for dementia care and an innovation-integrated curriculum for care management with Entrustable Professional Activities (EPAs), lectures, Situated Simulation Learning, Team-based learning, and Objective Structured Clinical Examination(OSCE).
  arm group label: curriculum integration Group
  other name: experimental group
  intervention type: Other
  intervention name: Traditional classroom teaching course programs
  description: The conventional teaching group will receive only traditional classroom teaching course programs.
  arm group label: conventional teaching group
  other name: Control Group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Huei-Ling Huang, PhD
  role: Study Chair
  affiliation: Chang Gung University of Science and Technology
  last name: Huei-Ling Huang, PhD
  phone: +886-3-2118999
  phone ext: 5803
  email: hlhuang@gw.cgust.edu.tw
  facility: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Chang Gung Memorial Hospital
  investigator full name: Huei-Ling Huang
  investigator title: Associate Professor, PhD, RN, Department of Gerontology and Health Care Management, College of Nursing, Chang Gung University of Science and Technology, Taoyuan, Taiwan, R.O.C
  mesh term: Dementia