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/NCT06030466</url>
    </required_header>
    <id_info>
      <org_study_id>202307039RINA</org_study_id>
      <nct_id>NCT06030466</nct_id>
    </id_info>
    <brief_title>Medical Students' Acceptance and Learning Efficacy With Physical and Virtual Standardized Patients</brief_title>
    <official_title>A Comparative Study of Medical Students' Acceptance and Learning Efficacy With Physical and Virtual Standardized Patients</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>
        This study will focus on exploring the experiential differences between virtual standardized&#xD;
        patients and physical standardized patients, gathering feedback through questionnaires and&#xD;
        brief interviews. Standardized patients have been widely used in medical education and&#xD;
        physician licensing exams in Taiwan for over 15 years. With the rise of technology-enhanced&#xD;
        medical education, it is necessary to reexamine the professional attributes and&#xD;
        identification of standardized patients and explore the implementation of virtual&#xD;
        standardized patient systems. The research aims to reshape the professional identity of&#xD;
        standardized patients, identify necessary attributes and competencies, and establish a&#xD;
        virtual standardized patient system to assess medical students' acceptance and learning&#xD;
        outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research project aims to investigate the differences in acceptance and learning efficacy&#xD;
        between physical standardized patients and virtual standardized patients among medical&#xD;
        students. Participants will be randomly assigned to either the physical standardized patient&#xD;
        group or the virtual standardized patient group. They will experience scenarios with real&#xD;
        standardized patients or screen-based virtual standardized patients, engaging in activities&#xD;
        such as taking medical histories and explaining conditions. The study will collect&#xD;
        questionnaire feedback on learning efficacy and acceptance.&#xD;
  &#xD;
        The primary research questions include: Are there differences in medical students'&#xD;
        perceptions of teaching scenarios involving virtual standardized patients versus physical&#xD;
        standardized patients? Are there differences in medical students' self-efficacy growth after&#xD;
        practicing teaching scenarios with virtual standardized patients versus real standardized&#xD;
        patients? Secondary research questions include: What professional attributes and competencies&#xD;
        should standardized patients possess? Does technological literacy influence medical students'&#xD;
        acceptance of virtual standardized patients? How do virtual and physical standardized patient&#xD;
        scenarios differ in terms of perceptions by standardized patients and learners?&#xD;
  &#xD;
        This study will focus on exploring the experiential differences between virtual standardized&#xD;
        patients and physical standardized patients, gathering feedback through questionnaires and&#xD;
        brief interviews. Standardized patients have been widely used in medical education and&#xD;
        physician licensing exams in Taiwan for over 15 years. With the rise of technology-enhanced&#xD;
        medical education, it is necessary to reexamine the professional attributes and&#xD;
        identification of standardized patients and explore the implementation of virtual&#xD;
        standardized patient systems. The research aims to reshape the professional identity of&#xD;
        standardized patients, identify necessary attributes and competencies, and establish a&#xD;
        virtual standardized patient system to assess medical students' acceptance and learning&#xD;
        outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 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>Crossover Assignment</intervention_model>
      <intervention_model_description>Randomization with crossover design</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Perception differences between medical student using virtual standardized patients and physical standardized patients.</measure>
      <time_frame>1 year</time_frame>
      <description>Perception questionnaire including satisfaction, acceptability</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Learning efficacy difference between medical student using virtual standardized patients and physical standardized patients.</measure>
      <time_frame>1 year</time_frame>
      <description>Knowledge testing regarding history taking and physician-patient communication</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Education, Medical</condition>
    <arm_group>
      <arm_group_label>With physical standardized patients</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Medical students practice consultation with physical standardized patients.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>With virtual standardized patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Medical students practice consultation with virtual standardized patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>With virtual standardized patients</intervention_name>
      <description>The virtual standardized patient is a software system that presents on a computer screen like a video conference, allowing medical students to interact with it for medical consultation. The virtual character modeling adopts 3D model, the expression of the character is delicate, and the voice feedback is clear. After the students' questions are asked by voice recognition and key words are extracted, appropriate responses are given.</description>
      <arm_group_label>With virtual standardized patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>With physical standardized patients</intervention_name>
      <description>The physical standardized patient is a real person who has received professional training courses in the department of medical education of National Taiwan University Hospital, and can help medical students practice consultations.</description>
      <arm_group_label>With physical standardized patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Medical students studying at the National Taiwan University School of Medicine&#xD;
  &#xD;
            2. Able to understand the research case and sign the written consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Has used relevant virtual standardized patient software in the past (past exposure)&#xD;
  &#xD;
            2. Unable to adapt to technological applications or successfully use this virtual&#xD;
               standardized patient system (unable to cooperate with research)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Cheng-Heng Liu, MD</last_name>
      <phone>+886988389269</phone>
      <email>henry780930@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Medical Education, National Taiwan University Hospital</name>
        <address>
          <city>Taipei City</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <contact>
        <last_name>Cheng-Heng Liu, MD</last_name>
        <phone>+886988389269</phone>
        <email>henry780930@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06030466
  org study id: 202307039RINA
  nct id: NCT06030466
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will focus on exploring the experiential differences between virtual standardized
        patients and physical standardized patients, gathering feedback through questionnaires and
        brief interviews. Standardized patients have been widely used in medical education and
        physician licensing exams in Taiwan for over 15 years. With the rise of technology-enhanced
        medical education, it is necessary to reexamine the professional attributes and
        identification of standardized patients and explore the implementation of virtual
        standardized patient systems. The research aims to reshape the professional identity of
        standardized patients, identify necessary attributes and competencies, and establish a
        virtual standardized patient system to assess medical students' acceptance and learning
        outcomes.
  This research project aims to investigate the differences in acceptance and learning efficacy
        between physical standardized patients and virtual standardized patients among medical
        students. Participants will be randomly assigned to either the physical standardized patient
        group or the virtual standardized patient group. They will experience scenarios with real
        standardized patients or screen-based virtual standardized patients, engaging in activities
        such as taking medical histories and explaining conditions. The study will collect
        questionnaire feedback on learning efficacy and acceptance.
  
        The primary research questions include: Are there differences in medical students'
        perceptions of teaching scenarios involving virtual standardized patients versus physical
        standardized patients? Are there differences in medical students' self-efficacy growth after
        practicing teaching scenarios with virtual standardized patients versus real standardized
        patients? Secondary research questions include: What professional attributes and competencies
        should standardized patients possess? Does technological literacy influence medical students'
        acceptance of virtual standardized patients? How do virtual and physical standardized patient
        scenarios differ in terms of perceptions by standardized patients and learners?
  
        This study will focus on exploring the experiential differences between virtual standardized
        patients and physical standardized patients, gathering feedback through questionnaires and
        brief interviews. Standardized patients have been widely used in medical education and
        physician licensing exams in Taiwan for over 15 years. With the rise of technology-enhanced
        medical education, it is necessary to reexamine the professional attributes and
        identification of standardized patients and explore the implementation of virtual
        standardized patient systems. The research aims to reshape the professional identity of
        standardized patients, identify necessary attributes and competencies, and establish a
        virtual standardized patient system to assess medical students' acceptance and learning
        outcomes.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomization with crossover design
  primary purpose: Other
  masking: None (Open Label)
  measure: Perception differences between medical student using virtual standardized patients and physical standardized patients.
  time frame: 1 year
  description: Perception questionnaire including satisfaction, acceptability
  measure: Learning efficacy difference between medical student using virtual standardized patients and physical standardized patients.
  time frame: 1 year
  description: Knowledge testing regarding history taking and physician-patient communication
  arm group label: With physical standardized patients
  arm group type: Other
  description: Medical students practice consultation with physical standardized patients.
  arm group label: With virtual standardized patients
  arm group type: Experimental
  description: Medical students practice consultation with virtual standardized patients.
  intervention type: Other
  intervention name: With virtual standardized patients
  description: The virtual standardized patient is a software system that presents on a computer screen like a video conference, allowing medical students to interact with it for medical consultation. The virtual character modeling adopts 3D model, the expression of the character is delicate, and the voice feedback is clear. After the students' questions are asked by voice recognition and key words are extracted, appropriate responses are given.
  arm group label: With virtual standardized patients
  intervention type: Other
  intervention name: With physical standardized patients
  description: The physical standardized patient is a real person who has received professional training courses in the department of medical education of National Taiwan University Hospital, and can help medical students practice consultations.
  arm group label: With physical standardized patients
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Cheng-Heng Liu, MD
  phone: +886988389269
  email: henry780930@gmail.com
  facility: 
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  sharing ipd: No