<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/NCT04495361</url>
  </required_header>
  <id_info>
    <org_study_id>16/136/108</org_study_id>
    <nct_id>NCT04495361</nct_id>
  </id_info>
  <brief_title>Online Learning Portal on Under Five Pneumonia</brief_title>
  <official_title>A Pedagogical Research on Use of an Online Learning Platform by Final Year Medical on Under Five Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maternal, Neonatal and Child Health Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</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>
      Despite the availability of standard pneumonia management guidelines and multiple global&#xD;
      efforts, pneumonia continues to be the leading killer of children under five, accounting to&#xD;
      around 17% of the total under five deaths globally. In Pakistan, pneumonia contributes to 16%&#xD;
      of under five mortality in the country having a well-defined yet poorly functional healthcare&#xD;
      system.&#xD;
&#xD;
      Although, there are standard set of guidelines for management of pneumonia patients however,&#xD;
      the management practices of this illness are variable across the country. This could be&#xD;
      attributed to non-availability of work ready graduates which in turn is due to variations of&#xD;
      teaching methods across various institutions. Although the medical students across these&#xD;
      institutions do get exposed to clinical cases in the final year however, this exposure is&#xD;
      also variable. If this clinical experience is coupled with an adjunct capacity building mode&#xD;
      using an online platform. there is a possibility that students could be trained in a better&#xD;
      way.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators plan to use e-learning portal in identification and management of under&#xD;
      five pneumonia cases as it is one of the leading killers of children under five which is&#xD;
      largely managed non-uniformly across the country. The investigators will use videos of&#xD;
      patients under five years of age with pneumonia and allow virtual performance of clinical&#xD;
      skills by medical students in an online platform. Such a platform can prove to be an adjunct&#xD;
      to standard clinical education rather than a substitute. The investigators propose that this&#xD;
      platform will help the medical students to prepare them for a range of clinical challenges as&#xD;
      it is an ideal strategy for the development, refinement, and rehearsal of skills in&#xD;
      recognition in a safe environment.&#xD;
&#xD;
      Primary Objective: To measure final year medical student's theoretical (knowledge) and&#xD;
      applied (virtual clinical performance) learning on under five pneumonia case management in an&#xD;
      e-learning package&#xD;
&#xD;
      Secondary Objective: To explore associations between student characteristics and outcomes&#xD;
      following exposure to the e-learning program&#xD;
&#xD;
      Study design: This will be a multi-center quasi experimental study with final year medical&#xD;
      students studying in various institutions in the twin cities of Pakistan&#xD;
      (Islamabad/Rawalpindi).&#xD;
&#xD;
      The design of the package will be based on the FIRST2ACT Web platform which is an e-learning&#xD;
      platform for medical students which focuses on exposure of the users to different adult&#xD;
      simulated case scenarios in the form of videos.&#xD;
&#xD;
      Three categories of case scenarios, based on WHO classification of pneumonia, will be&#xD;
      presented to the students. Thus case scenarios of patients with no pneumonia, pneumonia and&#xD;
      severe pneumonia will be presented.&#xD;
&#xD;
      Stages of study: The study will be conducted in the following three stages all of which will&#xD;
      be mostly conducted electronically.&#xD;
&#xD;
      Pre-intervention stage:&#xD;
&#xD;
      Piloting of existing resources: The case scenarios will be created of children under five&#xD;
      suffering from pneumonia. The host organization MNCHRN has an archive of different videos of&#xD;
      patients of pneumonia already available which have been developed as a part of another&#xD;
      activity. Consent forms from the caregivers of the patients in the videos including&#xD;
      permission to use them in future for other purposes are in the record. These videos after&#xD;
      testing will be incorporated in the program. If it is felt that the existing content does not&#xD;
      fulfil the purpose, then new videos will be recorded of under five pneumonia cases in a&#xD;
      hospital facility by taking consent from the caregivers.&#xD;
&#xD;
      Development of new cases: If required, new videos showing different types of pneumonia in&#xD;
      under five children visiting a clinic or admitted in a hospital will be recorded. Approval&#xD;
      from the clinic/ hospital will be taken to include their patients and to record videos in&#xD;
      their premises. Consent from the carers/parents to videotape their children would also be&#xD;
      taken. Details on the purpose of the study and their participation will be explained to them&#xD;
      and will also be provided in written form prior to signing the consent form.&#xD;
&#xD;
      Development and testing of portal: Who, how, where, what framework shall be employed for the&#xD;
      development and implementation of the e-learning package. An expert of IT will be recruited&#xD;
      for the development of portal. Portal will be tested by the research team, medical students&#xD;
      and paediatricians.&#xD;
&#xD;
      Invitation to institutions to participate: The heads of each institution will be approached&#xD;
      to provide permission for involvement of their final year medical students. Approval and&#xD;
      ethical clearance from institution's research committees will be taken.&#xD;
&#xD;
      Introductory seminar: After approval, seminars for final year medical students to facilitate&#xD;
      their participation in the study will be conducted in each institution. Purpose of the study&#xD;
      and the use of portal will be explained to them. Information sheets and consent forms will be&#xD;
      distributed to the students at the end of the seminar and they will be given one week to&#xD;
      consider the information and decide if they want to participate.&#xD;
&#xD;
      Participant's consent and enrolment: Name of the student and institution, age, gender, phone&#xD;
      number, email address will be taken from the interested students at the time of enrolment in&#xD;
      the study. Once enrolled, the students will be informed that a login ID to access the e&#xD;
      learning platform will be provided at their email addresses. The same login ID will be used&#xD;
      as the participant's identifier and the means of linking individual data throughout the&#xD;
      study.&#xD;
&#xD;
      The following online questionnaires will be filled in by the enrolled students after they log&#xD;
      on to the portal for the first time.&#xD;
&#xD;
        1. Demographic and clinical experience&#xD;
&#xD;
        2. Pre-test self-assessment of knowledge, skills, confidence, and competence&#xD;
&#xD;
      Study debriefing: Each participant will be able to access a narrated PowerPoint presentation&#xD;
      on the intervention with instructions within the portal. The briefing will describe the&#xD;
      approach and scenarios in general with examples the participants would see and instructions&#xD;
      on selecting clinical actions and receiving feedback. It will also explain the parameters&#xD;
      (number of attempts and time taken to complete the case scenario) that will be accounted in&#xD;
      the scoring.&#xD;
&#xD;
      Intervention stage:&#xD;
&#xD;
      Exposure on online clinical cases: This will be an online program; therefore the students&#xD;
      will be able to access it anywhere and anytime they feel convenient provided there is&#xD;
      internet connectivity. In case there is interruption of internet due to electricity shortage,&#xD;
      efforts will be made to keep the interface such that the students takes up from where they&#xD;
      left provided the shortage is not of more than one hour as the student might forget some&#xD;
      components of the training.&#xD;
&#xD;
      Students after log in to the portal will undergo a planned electronic encounter with an under&#xD;
      five patient suffering from pneumonia. For each case, students will have to identify the&#xD;
      category of pneumonia and the appropriate treatment/ management in a timed session The&#xD;
      interface will be developed such that upon login, the student will be given an opportunity to&#xD;
      select cases. Upon clicking on the icon of the age group, the participant will have a screen&#xD;
      popping up showing a typical case of either no pneumonia, pneumonia or severe pneumonia. The&#xD;
      video will run for around thirty seconds to one minute during and after which the students&#xD;
      will try to identify the case and select it from the drop down menu of whether it is no&#xD;
      pneumonia, pneumonia or severe pneumonia. There will be tabs for history, examination,&#xD;
      diagnosis and management. The student will select the best suited response from a range of&#xD;
      options.Based on the selection of the response and the time taken to do so, a score will be&#xD;
      generated. The student can take three attempts for each case scenario. The total score will&#xD;
      be an average of all attempts.&#xD;
&#xD;
      Feedback on the scored performance: Based on the score the student will be provided with&#xD;
      general formative feedback incorporating patient diagnosis and best practice management for&#xD;
      that case.&#xD;
&#xD;
      The intervention will continue for six months with instructions to log in every month.&#xD;
&#xD;
      Post-intervention stage: Participants will complete the knowledge post-test and a&#xD;
      self-evaluation of skills, competence and confidence in managing under five patients after&#xD;
      the intervention. The overall performance of each student will be scored and students will&#xD;
      receive a summarized feedback and provided with links to resources for further self-directed&#xD;
      learning. Finally, they will complete an evaluation of their experience and receive a&#xD;
      printable certificate of completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Students will be exposed to an online learning portal in which they will undergo planned electronic encounters with under five patients having pneumonia. For each case, students will have to identify the category of pneumonia and the appropriate treatment/ management in a timed session.&#xD;
Upon clicking on the available case, the participant will be shown a typical case of either no pneumonia, pneumonia or severe pneumonia. The video will run for around thirty seconds to one minute during and after which the students will try to identify the case and select its category from the drop down menu of diagnosis. There will be tabs for history, examination, diagnosis and management. The student will select the best suited response from a range of options. Based on the selection of the response and the time taken to do so, a score will be generated. The student can take two attempts for each case. Students will be required to a login for 6 months whereby 3 cases will be assigned per month.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline knowledge of all participants on under five pneumonia at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Self administered questionnaire with multiple choice questions will be filled by the participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline confidence in skills of all participants in diagnosing and managing under five pneumonia at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Self-administered Likert scale questionnaire will be filled by the participants</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Pneumonia</condition>
  <condition>Childhood Pneumonia</condition>
  <condition>Infectious Disease</condition>
  <condition>Acute Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>Online learning portal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Final year medical students will use an online learning portal in which three case scenarios of under five pneumonia patients will be displayed each month. Based on history and examination, the user will diagnose and manage the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-learning portal</intervention_name>
    <description>An online learning portal for the identification and management of pneumonia in under five children</description>
    <arm_group_label>Online learning portal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria for medical students:&#xD;
&#xD;
          -  Final year medical students studying in institutions in Rawalpindi/Islamabad&#xD;
             registered under the higher education commission&#xD;
&#xD;
          -  Medical students whose heads have provided permission to undertake the study with them&#xD;
&#xD;
          -  Medical students who have provided a written consent to be included in the study.&#xD;
&#xD;
        Inclusion Criteria for pneumonia patients&#xD;
&#xD;
          -  Patients less than five years diagnosed with no pneumonia, pneumonia or severe&#xD;
             pneumonia&#xD;
&#xD;
          -  Parents/Carers who provide consent for their under five children to be videotaped.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria fro medical students&#xD;
&#xD;
          -  Medical students withdrawing/leaving the institute&#xD;
&#xD;
          -  Medical students who are not in final year&#xD;
&#xD;
        Exclusion Criteria for pneumonia patients&#xD;
&#xD;
          -  Patients under five suffering from comorbidity with pneumonia&#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_official>
    <last_name>Dr Tabish Hazir, MBBS, FRCPCH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maternal, Neonatal and Child Health Research Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MNCHRN</name>
      <address>
        <city>Islamabad</city>
        <state>Federal</state>
        <zip>44000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Childhood Pneumonia</keyword>
  <keyword>Acute respiratory illness</keyword>
  <keyword>Pakistan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT04495361
org study id: 16/136/108
nct id: NCT04495361
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite the availability of standard pneumonia management guidelines and multiple global
      efforts, pneumonia continues to be the leading killer of children under five, accounting to
      around 17% of the total under five deaths globally. In Pakistan, pneumonia contributes to 16%
      of under five mortality in the country having a well-defined yet poorly functional healthcare
      system.

      Although, there are standard set of guidelines for management of pneumonia patients however,
      the management practices of this illness are variable across the country. This could be
      attributed to non-availability of work ready graduates which in turn is due to variations of
      teaching methods across various institutions. Although the medical students across these
      institutions do get exposed to clinical cases in the final year however, this exposure is
      also variable. If this clinical experience is coupled with an adjunct capacity building mode
      using an online platform. there is a possibility that students could be trained in a better
      way.
The investigators plan to use e-learning portal in identification and management of under
      five pneumonia cases as it is one of the leading killers of children under five which is
      largely managed non-uniformly across the country. The investigators will use videos of
      patients under five years of age with pneumonia and allow virtual performance of clinical
      skills by medical students in an online platform. Such a platform can prove to be an adjunct
      to standard clinical education rather than a substitute. The investigators propose that this
      platform will help the medical students to prepare them for a range of clinical challenges as
      it is an ideal strategy for the development, refinement, and rehearsal of skills in
      recognition in a safe environment.

      Primary Objective: To measure final year medical student's theoretical (knowledge) and
      applied (virtual clinical performance) learning on under five pneumonia case management in an
      e-learning package

      Secondary Objective: To explore associations between student characteristics and outcomes
      following exposure to the e-learning program

      Study design: This will be a multi-center quasi experimental study with final year medical
      students studying in various institutions in the twin cities of Pakistan
      (Islamabad/Rawalpindi).

      The design of the package will be based on the FIRST2ACT Web platform which is an e-learning
      platform for medical students which focuses on exposure of the users to different adult
      simulated case scenarios in the form of videos.

      Three categories of case scenarios, based on WHO classification of pneumonia, will be
      presented to the students. Thus case scenarios of patients with no pneumonia, pneumonia and
      severe pneumonia will be presented.

      Stages of study: The study will be conducted in the following three stages all of which will
      be mostly conducted electronically.

      Pre-intervention stage:

      Piloting of existing resources: The case scenarios will be created of children under five
      suffering from pneumonia. The host organization MNCHRN has an archive of different videos of
      patients of pneumonia already available which have been developed as a part of another
      activity. Consent forms from the caregivers of the patients in the videos including
      permission to use them in future for other purposes are in the record. These videos after
      testing will be incorporated in the program. If it is felt that the existing content does not
      fulfil the purpose, then new videos will be recorded of under five pneumonia cases in a
      hospital facility by taking consent from the caregivers.

      Development of new cases: If required, new videos showing different types of pneumonia in
      under five children visiting a clinic or admitted in a hospital will be recorded. Approval
      from the clinic/ hospital will be taken to include their patients and to record videos in
      their premises. Consent from the carers/parents to videotape their children would also be
      taken. Details on the purpose of the study and their participation will be explained to them
      and will also be provided in written form prior to signing the consent form.

      Development and testing of portal: Who, how, where, what framework shall be employed for the
      development and implementation of the e-learning package. An expert of IT will be recruited
      for the development of portal. Portal will be tested by the research team, medical students
      and paediatricians.

      Invitation to institutions to participate: The heads of each institution will be approached
      to provide permission for involvement of their final year medical students. Approval and
      ethical clearance from institution's research committees will be taken.

      Introductory seminar: After approval, seminars for final year medical students to facilitate
      their participation in the study will be conducted in each institution. Purpose of the study
      and the use of portal will be explained to them. Information sheets and consent forms will be
      distributed to the students at the end of the seminar and they will be given one week to
      consider the information and decide if they want to participate.

      Participant's consent and enrolment: Name of the student and institution, age, gender, phone
      number, email address will be taken from the interested students at the time of enrolment in
      the study. Once enrolled, the students will be informed that a login ID to access the e
      learning platform will be provided at their email addresses. The same login ID will be used
      as the participant's identifier and the means of linking individual data throughout the
      study.

      The following online questionnaires will be filled in by the enrolled students after they log
      on to the portal for the first time.

        1. Demographic and clinical experience

        2. Pre-test self-assessment of knowledge, skills, confidence, and competence

      Study debriefing: Each participant will be able to access a narrated PowerPoint presentation
      on the intervention with instructions within the portal. The briefing will describe the
      approach and scenarios in general with examples the participants would see and instructions
      on selecting clinical actions and receiving feedback. It will also explain the parameters
      (number of attempts and time taken to complete the case scenario) that will be accounted in
      the scoring.

      Intervention stage:

      Exposure on online clinical cases: This will be an online program; therefore the students
      will be able to access it anywhere and anytime they feel convenient provided there is
      internet connectivity. In case there is interruption of internet due to electricity shortage,
      efforts will be made to keep the interface such that the students takes up from where they
      left provided the shortage is not of more than one hour as the student might forget some
      components of the training.

      Students after log in to the portal will undergo a planned electronic encounter with an under
      five patient suffering from pneumonia. For each case, students will have to identify the
      category of pneumonia and the appropriate treatment/ management in a timed session The
      interface will be developed such that upon login, the student will be given an opportunity to
      select cases. Upon clicking on the icon of the age group, the participant will have a screen
      popping up showing a typical case of either no pneumonia, pneumonia or severe pneumonia. The
      video will run for around thirty seconds to one minute during and after which the students
      will try to identify the case and select it from the drop down menu of whether it is no
      pneumonia, pneumonia or severe pneumonia. There will be tabs for history, examination,
      diagnosis and management. The student will select the best suited response from a range of
      options.Based on the selection of the response and the time taken to do so, a score will be
      generated. The student can take three attempts for each case scenario. The total score will
      be an average of all attempts.

      Feedback on the scored performance: Based on the score the student will be provided with
      general formative feedback incorporating patient diagnosis and best practice management for
      that case.

      The intervention will continue for six months with instructions to log in every month.

      Post-intervention stage: Participants will complete the knowledge post-test and a
      self-evaluation of skills, competence and confidence in managing under five patients after
      the intervention. The overall performance of each student will be scored and students will
      receive a summarized feedback and provided with links to resources for further self-directed
      learning. Finally, they will complete an evaluation of their experience and receive a
      printable certificate of completion.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Students will be exposed to an online learning portal in which they will undergo planned electronic encounters with under five patients having pneumonia. For each case, students will have to identify the category of pneumonia and the appropriate treatment/ management in a timed session.
Upon clicking on the available case, the participant will be shown a typical case of either no pneumonia, pneumonia or severe pneumonia. The video will run for around thirty seconds to one minute during and after which the students will try to identify the case and select its category from the drop down menu of diagnosis. There will be tabs for history, examination, diagnosis and management. The student will select the best suited response from a range of options. Based on the selection of the response and the time taken to do so, a score will be generated. The student can take two attempts for each case. Students will be required to a login for 6 months whereby 3 cases will be assigned per month.
primary purpose: Other
masking: None (Open Label)
measure: Change from baseline knowledge of all participants on under five pneumonia at 6 months
time frame: 6 months
description: Self administered questionnaire with multiple choice questions will be filled by the participants
measure: Change from baseline confidence in skills of all participants in diagnosing and managing under five pneumonia at 6 months
time frame: 6 months
description: Self-administered Likert scale questionnaire will be filled by the participants
arm group label: Online learning portal
arm group type: Experimental
description: Final year medical students will use an online learning portal in which three case scenarios of under five pneumonia patients will be displayed each month. Based on history and examination, the user will diagnose and manage the patient.
intervention type: Other
intervention name: E-learning portal
description: An online learning portal for the identification and management of pneumonia in under five children
arm group label: Online learning portal
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dr Tabish Hazir, MBBS, FRCPCH
role: Principal Investigator
affiliation: Maternal, Neonatal and Child Health Research Network
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Respiratory Tract Infections