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/NCT05963802</url>
    </required_header>
    <id_info>
      <org_study_id>AIHSS01</org_study_id>
      <nct_id>NCT05963802</nct_id>
    </id_info>
    <brief_title>Evaluation of the Efficacy and Usability of Artificial Intelligence (ChatGPT) for Health Sciences Students</brief_title>
    <acronym>AIHSS</acronym>
    <official_title>Crossover Randomized Controlled Trial to Evaluate the Efficacy and Usability of Artificial Intelligence (ChatGPT) for Health Sciences Students (AIHSS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Carleton University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Université de Montréal</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Carleton University</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>
        Crossover Randomized Control trial, in which subjects are randomly assigned to one of two&#xD;
        groups: one (ChatGPT) receiving the intervention that is being tested, and the control group&#xD;
        receiving usual online resources.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A two-stage randomization strategy will be adopted. The allocation of participants into event&#xD;
        groups A and B will be determined through computer-generated randomization in an allocation&#xD;
        ratio: 1:1. To address ethical concerns regarding power dynamics between professors and&#xD;
        students; the investigators have opted to involve an individual who is independent of the&#xD;
        research team. This decision aims to minimize any potential bias or influence that could&#xD;
        arise from direct professor involvement in the intervention. This approach helps ensure that&#xD;
        the study is conducted fairly and unbiasedly, fostering a research environment that&#xD;
        prioritizes equal opportunities for all participants. Both groups will simultaneously work on&#xD;
        an assignment (A and B).&#xD;
  &#xD;
        The investigators employed a cross-over design to ensure equity in the learning experience&#xD;
        for all students. This involved assigning students either the ChatGPD (A) or the regular&#xD;
        online tools (B) for accessing resources and assisting them with their assignments. During&#xD;
        the initial phase of the intervention, participants in group A will utilize ChatGPT to&#xD;
        complete their assignments, while participants in Group B will serve as the control group. In&#xD;
        the subsequent period, the interventions will switch between the two groups. To assess the&#xD;
        participants' technology usability, both groups will complete pre-and post-questionnaires.&#xD;
        Additionally, participants will be requested to fill out a post-intervention questionnaire to&#xD;
        evaluate their perceptions of the assistance methods. After a period of a wash-out of 13&#xD;
        days/week, participants who were previously allocated to Group A will be allocated to Group B&#xD;
        and the same with participants previously allocated to Group B will be to Group A. This&#xD;
        crossover randomized control trial will include 50 health sciences students who are&#xD;
        registered to the course Chronic Health Conditions and Disability ( HLTH 3503), Carleton&#xD;
        University. During the first part of the intervention, A group will use ChatGPT to complete&#xD;
        their assignment, while B participants will act as a control group. In the second week, the&#xD;
        interventions will cross over. Both groups' participants will complete a pre-and&#xD;
        post-questionnaire to assess their knowledge. Participants will also complete a&#xD;
        post-intervention questionnaire to evaluate their perceptions. The System Usability Scale&#xD;
        (SUS) will be administered at the end of the interventions and when participants cross over&#xD;
        to the other assistance tool. This allows for the assessment of outcomes and comparisons&#xD;
        within and between the two intervention arms. By collecting data at multiple points in the&#xD;
        study, the investigators can evaluate the effects of each intervention and any potential&#xD;
        carryover effects during the crossover period. Additionally, it provides an opportunity to&#xD;
        measure changes in outcomes within individual participants as they switch from one&#xD;
        intervention to another. The questionnaire about socioeconomic, literacy questions, Benefits&#xD;
        of AI and risks and negative experiences associated with AI usage.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>We employed a crossover design to ensure equity in the learning experience for all students. This involved assigning students either the ChatGPD (A) or the regular online tools (B) for accessing resources and assisting them with their assignments. During the initial phase of the intervention, participants in group A will utilize ChatGPT to complete their assignments, while participants in Group B will serve as the control group. In the subsequent period, the interventions will switch between the two groups.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Participants will be informed about the interventions they will be assigned to, ensuring transparency in the study. However, the investigator responsible for the allocation will be blinded to the group assignment of each participant, maintaining the integrity of the study design. To collect the outcomes, an individual external to the research team will be involved. This approach helps minimize potential bias and ensures the data collection process remains independent and unbiased.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>System Usability Scale (SUS) scores are 0-100,The average SUS score is 68.</measure>
      <time_frame>within 24 hours</time_frame>
      <description>Technology usability</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Student's perception of artificial intelligence, questionnaire reviwed by experts, No recognised gold standard measurement for outcome.</measure>
      <time_frame>within 24 hours</time_frame>
      <description>Student's perception about the use of artificial intelligence</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Educational Activities</condition>
    <condition>AI (Artificial Intelligence)</condition>
    <arm_group>
      <arm_group_label>Traditional Online tools Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Group B will serve as the control group in this study. Participants in this group will receive instructions on how to complete the assignment using traditional online tools available on the internet, without the use of artificial intelligence. They will have a timeframe of six days to complete the assignment using these conventional tools. Similar to participants in Arm 1, they will also be required to fill out a survey on technology usability, providing feedback on their experience with the online tools.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Artificial Intelligence (ChatGPT) Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in Group A will be assigned to utilize ChatGPT as their tool to complete assignments. They will be given a period of six days to utilize artificial intelligence through ChatGPT for assignment completion. Along with the assignment instructions, participants will receive an ethical guideline and specific guidelines on how to effectively utilize ChatGPT. Once the intervention period is concluded, participants will be given a 24-hour window to complete a survey that assesses the usability of the technology. The survey aims to gather valuable feedback on the participants' experience and perception of using ChatGPT for their assignments. In addition, participants in Arm 1 will also be asked to fill out a survey regarding their perception of using artificial intelligence (AI) as an assistance tool to complete their assignments. This survey aims to gather insights into their thoughts, opinions, and attitudes towards utilizing AI in the learning process</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Artificial Intelligence (ChatGPT) Group</intervention_name>
      <description>Participants in Group A will be assigned to utilize ChatGPT as their tool to complete assignments. They will be given a period of six days to utilize artificial intelligence through ChatGPT for assignment completion. Along with the assignment instructions, participants will receive an ethical guideline and specific guidelines on how to effectively utilize ChatGPT. Once the intervention period is concluded, participants will be given a 24-hour window to complete a survey that assesses the usability of the technology. The survey aims to gather valuable feedback on the participants' experience and perception of using ChatGPT for their assignments. In addition, participants in Arm 1 will also be asked to fill out a survey regarding their perception of using artificial intelligence (AI) as an assistance tool to complete their assignments. This survey aims to gather insights into their thoughts, opinions, and attitudes towards utilizing AI in the learning process.</description>
      <arm_group_label>Artificial Intelligence (ChatGPT) Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Health Science students&#xD;
  &#xD;
            -  Must be registered for the course Chronic Health Conditions and Disability (HLTH&#xD;
               3503), Fall 2023.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Unable to provide informed consent&#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>
    <overall_official>
      <last_name>Mirella Veras, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Carleton University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mirella Veras, PhD</last_name>
      <phone>613-520-2600</phone>
      <phone_ext>4848</phone_ext>
      <email>mirella.veras@carleton.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dahlia Kairy, PhD</last_name>
      <phone>514-343-6111</phone>
      <email>dahlia.kairy@umontreal.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Carleton University</name>
        <address>
          <city>Ottawa</city>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Mirella Veras, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <results_reference>
      <citation>Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019 Jul 31;366:l4378. doi: 10.1136/bmj.l4378.</citation>
      <PMID>31366597</PMID>
    </results_reference>
    <results_reference>
      <citation>Luna A, Casertano L, Timmerberg J, O'Neil M, Machowsky J, Leu CS, Lin J, Fang Z, Douglas W, Agrawal S. Artificial intelligence application versus physical therapist for squat evaluation: a randomized controlled trial. Sci Rep. 2021 Sep 13;11(1):18109. doi: 10.1038/s41598-021-97343-y.</citation>
      <PMID>34518568</PMID>
    </results_reference>
    <results_reference>
      <citation>Liu X, Rivera SC, Moher D, Calvert MJ, Denniston AK; SPIRIT-AI and CONSORT-AI Working Group. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension. BMJ. 2020 Sep 9;370:m3164. doi: 10.1136/bmj.m3164.</citation>
      <PMID>32909959</PMID>
    </results_reference>
    <results_reference>
      <citation>Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.</citation>
      <PMID>30973342</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Carleton University</investigator_affiliation>
      <investigator_full_name>Mirella Veras</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Artificial intelligence</keyword>
    <keyword>Education</keyword>
    <keyword>Health Science Students</keyword>
    <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/NCT05963802
  org study id: AIHSS01
  nct id: NCT05963802
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Crossover Randomized Control trial, in which subjects are randomly assigned to one of two
        groups: one (ChatGPT) receiving the intervention that is being tested, and the control group
        receiving usual online resources.
  A two-stage randomization strategy will be adopted. The allocation of participants into event
        groups A and B will be determined through computer-generated randomization in an allocation
        ratio: 1:1. To address ethical concerns regarding power dynamics between professors and
        students; the investigators have opted to involve an individual who is independent of the
        research team. This decision aims to minimize any potential bias or influence that could
        arise from direct professor involvement in the intervention. This approach helps ensure that
        the study is conducted fairly and unbiasedly, fostering a research environment that
        prioritizes equal opportunities for all participants. Both groups will simultaneously work on
        an assignment (A and B).
  
        The investigators employed a cross-over design to ensure equity in the learning experience
        for all students. This involved assigning students either the ChatGPD (A) or the regular
        online tools (B) for accessing resources and assisting them with their assignments. During
        the initial phase of the intervention, participants in group A will utilize ChatGPT to
        complete their assignments, while participants in Group B will serve as the control group. In
        the subsequent period, the interventions will switch between the two groups. To assess the
        participants' technology usability, both groups will complete pre-and post-questionnaires.
        Additionally, participants will be requested to fill out a post-intervention questionnaire to
        evaluate their perceptions of the assistance methods. After a period of a wash-out of 13
        days/week, participants who were previously allocated to Group A will be allocated to Group B
        and the same with participants previously allocated to Group B will be to Group A. This
        crossover randomized control trial will include 50 health sciences students who are
        registered to the course Chronic Health Conditions and Disability ( HLTH 3503), Carleton
        University. During the first part of the intervention, A group will use ChatGPT to complete
        their assignment, while B participants will act as a control group. In the second week, the
        interventions will cross over. Both groups' participants will complete a pre-and
        post-questionnaire to assess their knowledge. Participants will also complete a
        post-intervention questionnaire to evaluate their perceptions. The System Usability Scale
        (SUS) will be administered at the end of the interventions and when participants cross over
        to the other assistance tool. This allows for the assessment of outcomes and comparisons
        within and between the two intervention arms. By collecting data at multiple points in the
        study, the investigators can evaluate the effects of each intervention and any potential
        carryover effects during the crossover period. Additionally, it provides an opportunity to
        measure changes in outcomes within individual participants as they switch from one
        intervention to another. The questionnaire about socioeconomic, literacy questions, Benefits
        of AI and risks and negative experiences associated with AI usage.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: We employed a crossover design to ensure equity in the learning experience for all students. This involved assigning students either the ChatGPD (A) or the regular online tools (B) for accessing resources and assisting them with their assignments. During the initial phase of the intervention, participants in group A will utilize ChatGPT to complete their assignments, while participants in Group B will serve as the control group. In the subsequent period, the interventions will switch between the two groups.
  primary purpose: Other
  masking: Single (Investigator)
  masking description: Participants will be informed about the interventions they will be assigned to, ensuring transparency in the study. However, the investigator responsible for the allocation will be blinded to the group assignment of each participant, maintaining the integrity of the study design. To collect the outcomes, an individual external to the research team will be involved. This approach helps minimize potential bias and ensures the data collection process remains independent and unbiased.
  measure: System Usability Scale (SUS) scores are 0-100,The average SUS score is 68.
  time frame: within 24 hours
  description: Technology usability
  measure: Student's perception of artificial intelligence, questionnaire reviwed by experts, No recognised gold standard measurement for outcome.
  time frame: within 24 hours
  description: Student's perception about the use of artificial intelligence
  arm group label: Traditional Online tools Group
  arm group type: No Intervention
  description: Group B will serve as the control group in this study. Participants in this group will receive instructions on how to complete the assignment using traditional online tools available on the internet, without the use of artificial intelligence. They will have a timeframe of six days to complete the assignment using these conventional tools. Similar to participants in Arm 1, they will also be required to fill out a survey on technology usability, providing feedback on their experience with the online tools.
  arm group label: Artificial Intelligence (ChatGPT) Group
  arm group type: Experimental
  description: Participants in Group A will be assigned to utilize ChatGPT as their tool to complete assignments. They will be given a period of six days to utilize artificial intelligence through ChatGPT for assignment completion. Along with the assignment instructions, participants will receive an ethical guideline and specific guidelines on how to effectively utilize ChatGPT. Once the intervention period is concluded, participants will be given a 24-hour window to complete a survey that assesses the usability of the technology. The survey aims to gather valuable feedback on the participants' experience and perception of using ChatGPT for their assignments. In addition, participants in Arm 1 will also be asked to fill out a survey regarding their perception of using artificial intelligence (AI) as an assistance tool to complete their assignments. This survey aims to gather insights into their thoughts, opinions, and attitudes towards utilizing AI in the learning process
  intervention type: Other
  intervention name: Artificial Intelligence (ChatGPT) Group
  description: Participants in Group A will be assigned to utilize ChatGPT as their tool to complete assignments. They will be given a period of six days to utilize artificial intelligence through ChatGPT for assignment completion. Along with the assignment instructions, participants will receive an ethical guideline and specific guidelines on how to effectively utilize ChatGPT. Once the intervention period is concluded, participants will be given a 24-hour window to complete a survey that assesses the usability of the technology. The survey aims to gather valuable feedback on the participants' experience and perception of using ChatGPT for their assignments. In addition, participants in Arm 1 will also be asked to fill out a survey regarding their perception of using artificial intelligence (AI) as an assistance tool to complete their assignments. This survey aims to gather insights into their thoughts, opinions, and attitudes towards utilizing AI in the learning process.
  arm group label: Artificial Intelligence (ChatGPT) Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mirella Veras, PhD
  role: Principal Investigator
  affiliation: Carleton University
  last name: Mirella Veras, PhD
  phone: 613-520-2600
  phone ext: 4848
  email: mirella.veras@carleton.ca
  last name: Dahlia Kairy, PhD
  phone: 514-343-6111
  email: dahlia.kairy@umontreal.ca
  facility: 
  contact: 
  country: Canada
  citation: Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019 Jul 31;366:l4378. doi: 10.1136/bmj.l4378.
  PMID: 31366597
  citation: Luna A, Casertano L, Timmerberg J, O'Neil M, Machowsky J, Leu CS, Lin J, Fang Z, Douglas W, Agrawal S. Artificial intelligence application versus physical therapist for squat evaluation: a randomized controlled trial. Sci Rep. 2021 Sep 13;11(1):18109. doi: 10.1038/s41598-021-97343-y.
  PMID: 34518568
  citation: Liu X, Rivera SC, Moher D, Calvert MJ, Denniston AK; SPIRIT-AI and CONSORT-AI Working Group. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension. BMJ. 2020 Sep 9;370:m3164. doi: 10.1136/bmj.m3164.
  PMID: 32909959
  citation: Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.
  PMID: 30973342
  responsible party type: Principal Investigator
  investigator affiliation: Carleton University
  investigator full name: Mirella Veras
  investigator title: Principal Investigator
  sharing ipd: No