<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/NCT04449081</url>
  </required_header>
  <id_info>
    <org_study_id>MelakaMMC</org_study_id>
    <nct_id>NCT04449081</nct_id>
  </id_info>
  <brief_title>Knowledge, Attitude and Practice of Dental Students About COVID-19</brief_title>
  <official_title>Knowledge, Attitude and Practice About COVID-19 and Awareness of Infection Control to Prevent COVID-19 Transmission in Clinics and Perception About Online Learning During Lock Down Period: A Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Melaka Manipal Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Melaka Manipal Medical College</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>
      Coronavirus disease 2019 (abbreviated &quot;COVID- 19&quot;) is a pandemic respiratory disease that is&#xD;
      caused by a novel coronavirus and was first detected in December 2019 in Wuhan, China. The&#xD;
      disease is highly infectious, and its main clinical symptoms include fever, dry cough,&#xD;
      fatigue, myalgia, and dyspnoea.1 In China, 18.5% of the patients with COVID-19 developed to&#xD;
      the severe stage, which is characterized by acute respiratory distress syndrome, septic&#xD;
      shock, difficult-to-tackle metabolic acidosis, and bleeding and coagulation dysfunction.&#xD;
&#xD;
      After China, COVID-19 spread across the world and many governments implemented unprecedented&#xD;
      measures like suspension of public transportation, the closing of public spaces, close&#xD;
      management of communities, and isolation and care for infected people and suspected cases.&#xD;
      The Malaysian government had enforced Movement Control Order (MCO) from 18th March to 4th May&#xD;
      2020 and henceforth Conditional Movement Control Order (CMCO) until 9th June 2020. The battle&#xD;
      against COVID-19 is still continuing in Malaysia and all over the world.&#xD;
&#xD;
      Due to the CMO and CMCO in the country, public and private universities have activated the&#xD;
      e-learning mode for classes and as the government ordered, universities are closed and no&#xD;
      face-to-face activities allowed. This has forced students of all disciplines including&#xD;
      dentistry to stay at home which are wide-spread across Malaysia and shift to e- learning&#xD;
      mode. To guarantee the final success for fight against COVID-19, regardless of their&#xD;
      education status, students' adherence to these control measures are essential, which is&#xD;
      largely affected by their knowledge, attitudes, and practices (KAP) towards COVID-19 in&#xD;
      accordance with KAP theory. Once the restrictions are eased students have to come back and&#xD;
      resume their clinical work in the campus.&#xD;
&#xD;
      Hence, in this study we assessed the Knowledge, Attitude, and Practice (KAP) towards COVID-19&#xD;
      and the students preference for online learning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Due to the CMO and CMCO in the country, public and private universities have activated the&#xD;
      e-learning mode for classes and as the government ordered, universities are closed and no&#xD;
      face-to-face activities allowed. This has forced students of all disciplines including&#xD;
      dentistry to stay at home which is wide-spread across Malaysia and shift to e-learning mode.&#xD;
      To guarantee the final success for the fight against COVID-19, regardless of their education&#xD;
      status, students' adherence to these control measures is essential, which is largely affected&#xD;
      by their knowledge, attitudes, and practices (KAP) towards COVID-19 in accordance with KAP&#xD;
      theory.&#xD;
&#xD;
      Background:&#xD;
&#xD;
      In the KAP study conducted among residents in China, it was noticed that KAP scores were&#xD;
      associated with a lower likelihood of negative attitudes and preventive practices towards&#xD;
      COVID-2019. Most Chinese residents of a relatively high socioeconomic status, in particular&#xD;
      women, are knowledgeable about COVID-19, hold optimistic attitudes, and have appropriate&#xD;
      practices towards COVID-19. Health education programs aimed at improving COVID-19 knowledge&#xD;
      are helpful for Chinese residents to hold optimistic attitudes and maintain appropriate&#xD;
      practices. In a cross-sectional study among pregestational and pregnant women was conducted&#xD;
      in Shaanxi, China, women at the periconceptional period in Shaanxi lacked the total KAP level&#xD;
      of periconceptional healthcare, especially those who live in rural areas and have less&#xD;
      education. The authors concluded that government agencies should reinforce more effective&#xD;
      primary preventive measures and policies for the prevention of adverse pregnancy outcomes.&#xD;
&#xD;
      In a study aimed to assess the level of awareness, perception, and attitude regarding&#xD;
      COVID-19 and infection control among Jordanian dentists, the authors concluded that Jordanian&#xD;
      dentists were aware of COVID-19 symptoms, mode of transmission, and infection controls and&#xD;
      measures in dental clinics. But dentists had limited comprehension of the extra precautionary&#xD;
      measures that protect the dental staff and other patients from COVID-19. They also&#xD;
      recommended that it would be best practice to send National and international guidelines&#xD;
      established by the regional and national dental associations to all registered dentists&#xD;
      during a crisis, including the COVID-19 pandemic, to ensure that dentists are well informed&#xD;
      and aware of best practices and recommended disease management approaches.&#xD;
&#xD;
      The outbreak of COVID-19 was unprecedented and forced many universities to launch online&#xD;
      courses to ensure the continuity of teaching-learning activities, with students staying at&#xD;
      homes or dorms. It is a massive, challenging shift to move all the existing courses online in&#xD;
      a matter of days. In general, a complete online course requires an elaborate lesson plan&#xD;
      design, teaching materials such as audio and video contents, as well as technology support&#xD;
      teams.&#xD;
&#xD;
      Many academic institutions in Malaysia commit themselves to eLearning because they believe in&#xD;
      its effectiveness as an alternative approach to the traditional classroom method of&#xD;
      disseminating information. A study conducted on e-learning shows that higher education&#xD;
      institutions in Malaysia offer more than 50% of their courses online. The data also shows&#xD;
      that 13.8% of lecturers provide more than 80% online learning materials and that 44.6% of&#xD;
      students prefer to read materials uploaded by their lecturers. The findings also show that&#xD;
      students' preference for online courses is very encouraging. In fact, lecturers also agree&#xD;
      that the integration of e-learning into their courses has benefited students. In general, it&#xD;
      clearly shows that the application of e-learning is accepted by lecturers and students of&#xD;
      HEIs as an effective means of communication.&#xD;
&#xD;
      A national study was conducted to evaluate the self-perceived preparedness of final-year&#xD;
      dental undergraduate students in dental public universities in Malaysia. The authors&#xD;
      concluded that confidence and experience in some clinical skills, cognitive and behavioral&#xD;
      attributes could be improved to facilitate their transition into independent dental practice&#xD;
      after graduation. This is best possible in face-to-face teaching. So given this unprecedented&#xD;
      situation, it will be best to assess the perception of dental students towards online&#xD;
      teaching.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2020</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge, Attitude, Practice of dental students towards COVID-19</measure>
    <time_frame>4 months</time_frame>
    <description>KAP towards COVID-19 was assessed using validated questionnnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Awareness level about Infection control to prevent COVID-19 transmission in clinics</measure>
    <time_frame>4 months</time_frame>
    <description>Awareness level about Infection control to prevent COVID-19 transmission in clinics was assesed using a standardized questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preference towards online learning.</measure>
    <time_frame>4 months</time_frame>
    <description>Preference towards online learning. was assessed using a standard questionnaire</description>
  </secondary_outcome>
  <enrollment type="Actual">215</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <condition>Corona Virus Infection</condition>
  <condition>Acute Lung Injury</condition>
  <condition>Fever</condition>
  <condition>Myalgia</condition>
  <condition>Cough</condition>
  <condition>Dyspnea</condition>
  <condition>Septic Shock</condition>
  <condition>Bleeding</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Knowledge, Attitude, Practice, Awareness, Preference</intervention_name>
    <description>KAP, Awareness level and Preference were assessed using questionnaires</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consenting participants of year 3, 4 and undergraduate dental students studying at&#xD;
        Faculty of Dentistry, Melaka-Manipal Medical College, Melaka, were included in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consenting participants of year 3, 4 and undergraduate dental students studying at&#xD;
             Faculty of Dentistry, Melaka-Manipal Medical College, Melaka&#xD;
&#xD;
          -  Age - 18-30 years&#xD;
&#xD;
          -  All gender&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajesh Hosadurga, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Melaka-Manipal Medical College, Melaka, Malaysia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, Melaka-Manipal Medical College</name>
      <address>
        <city>Melaka Tengah</city>
        <state>Melaka</state>
        <zip>57150</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <reference>
    <citation>Zhong BL, Luo W, Li HM, Zhang QQ, Liu XG, Li WT, Li Y. Knowledge, attitudes, and practices towards COVID-19 among Chinese residents during the rapid rise period of the COVID-19 outbreak: a quick online cross-sectional survey. Int J Biol Sci. 2020 Mar 15;16(10):1745-1752. doi: 10.7150/ijbs.45221. eCollection 2020.</citation>
    <PMID>32226294</PMID>
  </reference>
  <reference>
    <citation>Khader Y, Al Nsour M, Al-Batayneh OB, Saadeh R, Bashier H, Alfaqih M, Al-Azzam S, AlShurman BA. Dentists' Awareness, Perception, and Attitude Regarding COVID-19 and Infection Control: Cross-Sectional Study Among Jordanian Dentists. JMIR Public Health Surveill. 2020 Apr 9;6(2):e18798. doi: 10.2196/18798.</citation>
    <PMID>32250959</PMID>
  </reference>
  <reference>
    <citation>Asiry MA. Dental students' perceptions of an online learning. Saudi Dent J. 2017 Oct;29(4):167-170. doi: 10.1016/j.sdentj.2017.03.005. Epub 2017 Aug 2.</citation>
    <PMID>29033527</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Melaka Manipal Medical College</investigator_affiliation>
    <investigator_full_name>Rajesh Hosadurga</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Humans</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Online learning</keyword>
  <keyword>Perception</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Myalgia</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Lung Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No personal details of the participant will be shared.</ipd_description>
  </patient_data>
  <!-- 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/NCT04449081
org study id: MelakaMMC
nct id: NCT04449081
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease 2019 (abbreviated "COVID- 19") is a pandemic respiratory disease that is
      caused by a novel coronavirus and was first detected in December 2019 in Wuhan, China. The
      disease is highly infectious, and its main clinical symptoms include fever, dry cough,
      fatigue, myalgia, and dyspnoea.1 In China, 18.5% of the patients with COVID-19 developed to
      the severe stage, which is characterized by acute respiratory distress syndrome, septic
      shock, difficult-to-tackle metabolic acidosis, and bleeding and coagulation dysfunction.

      After China, COVID-19 spread across the world and many governments implemented unprecedented
      measures like suspension of public transportation, the closing of public spaces, close
      management of communities, and isolation and care for infected people and suspected cases.
      The Malaysian government had enforced Movement Control Order (MCO) from 18th March to 4th May
      2020 and henceforth Conditional Movement Control Order (CMCO) until 9th June 2020. The battle
      against COVID-19 is still continuing in Malaysia and all over the world.

      Due to the CMO and CMCO in the country, public and private universities have activated the
      e-learning mode for classes and as the government ordered, universities are closed and no
      face-to-face activities allowed. This has forced students of all disciplines including
      dentistry to stay at home which are wide-spread across Malaysia and shift to e- learning
      mode. To guarantee the final success for fight against COVID-19, regardless of their
      education status, students' adherence to these control measures are essential, which is
      largely affected by their knowledge, attitudes, and practices (KAP) towards COVID-19 in
      accordance with KAP theory. Once the restrictions are eased students have to come back and
      resume their clinical work in the campus.

      Hence, in this study we assessed the Knowledge, Attitude, and Practice (KAP) towards COVID-19
      and the students preference for online learning.
Due to the CMO and CMCO in the country, public and private universities have activated the
      e-learning mode for classes and as the government ordered, universities are closed and no
      face-to-face activities allowed. This has forced students of all disciplines including
      dentistry to stay at home which is wide-spread across Malaysia and shift to e-learning mode.
      To guarantee the final success for the fight against COVID-19, regardless of their education
      status, students' adherence to these control measures is essential, which is largely affected
      by their knowledge, attitudes, and practices (KAP) towards COVID-19 in accordance with KAP
      theory.

      Background:

      In the KAP study conducted among residents in China, it was noticed that KAP scores were
      associated with a lower likelihood of negative attitudes and preventive practices towards
      COVID-2019. Most Chinese residents of a relatively high socioeconomic status, in particular
      women, are knowledgeable about COVID-19, hold optimistic attitudes, and have appropriate
      practices towards COVID-19. Health education programs aimed at improving COVID-19 knowledge
      are helpful for Chinese residents to hold optimistic attitudes and maintain appropriate
      practices. In a cross-sectional study among pregestational and pregnant women was conducted
      in Shaanxi, China, women at the periconceptional period in Shaanxi lacked the total KAP level
      of periconceptional healthcare, especially those who live in rural areas and have less
      education. The authors concluded that government agencies should reinforce more effective
      primary preventive measures and policies for the prevention of adverse pregnancy outcomes.

      In a study aimed to assess the level of awareness, perception, and attitude regarding
      COVID-19 and infection control among Jordanian dentists, the authors concluded that Jordanian
      dentists were aware of COVID-19 symptoms, mode of transmission, and infection controls and
      measures in dental clinics. But dentists had limited comprehension of the extra precautionary
      measures that protect the dental staff and other patients from COVID-19. They also
      recommended that it would be best practice to send National and international guidelines
      established by the regional and national dental associations to all registered dentists
      during a crisis, including the COVID-19 pandemic, to ensure that dentists are well informed
      and aware of best practices and recommended disease management approaches.

      The outbreak of COVID-19 was unprecedented and forced many universities to launch online
      courses to ensure the continuity of teaching-learning activities, with students staying at
      homes or dorms. It is a massive, challenging shift to move all the existing courses online in
      a matter of days. In general, a complete online course requires an elaborate lesson plan
      design, teaching materials such as audio and video contents, as well as technology support
      teams.

      Many academic institutions in Malaysia commit themselves to eLearning because they believe in
      its effectiveness as an alternative approach to the traditional classroom method of
      disseminating information. A study conducted on e-learning shows that higher education
      institutions in Malaysia offer more than 50% of their courses online. The data also shows
      that 13.8% of lecturers provide more than 80% online learning materials and that 44.6% of
      students prefer to read materials uploaded by their lecturers. The findings also show that
      students' preference for online courses is very encouraging. In fact, lecturers also agree
      that the integration of e-learning into their courses has benefited students. In general, it
      clearly shows that the application of e-learning is accepted by lecturers and students of
      HEIs as an effective means of communication.

      A national study was conducted to evaluate the self-perceived preparedness of final-year
      dental undergraduate students in dental public universities in Malaysia. The authors
      concluded that confidence and experience in some clinical skills, cognitive and behavioral
      attributes could be improved to facilitate their transition into independent dental practice
      after graduation. This is best possible in face-to-face teaching. So given this unprecedented
      situation, it will be best to assess the perception of dental students towards online
      teaching.
observational model: Cohort
time perspective: Cross-Sectional
measure: Knowledge, Attitude, Practice of dental students towards COVID-19
time frame: 4 months
description: KAP towards COVID-19 was assessed using validated questionnnaire
measure: Awareness level about Infection control to prevent COVID-19 transmission in clinics
time frame: 4 months
description: Awareness level about Infection control to prevent COVID-19 transmission in clinics was assesed using a standardized questionnaire
measure: Preference towards online learning.
time frame: 4 months
description: Preference towards online learning. was assessed using a standard questionnaire
intervention type: Behavioral
intervention name: Knowledge, Attitude, Practice, Awareness, Preference
description: KAP, Awareness level and Preference were assessed using questionnaires
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rajesh Hosadurga, Ph.D
role: Principal Investigator
affiliation: Melaka-Manipal Medical College, Melaka, Malaysia
facility: 
country: Malaysia
citation: Zhong BL, Luo W, Li HM, Zhang QQ, Liu XG, Li WT, Li Y. Knowledge, attitudes, and practices towards COVID-19 among Chinese residents during the rapid rise period of the COVID-19 outbreak: a quick online cross-sectional survey. Int J Biol Sci. 2020 Mar 15;16(10):1745-1752. doi: 10.7150/ijbs.45221. eCollection 2020.
PMID: 32226294
citation: Khader Y, Al Nsour M, Al-Batayneh OB, Saadeh R, Bashier H, Alfaqih M, Al-Azzam S, AlShurman BA. Dentists' Awareness, Perception, and Attitude Regarding COVID-19 and Infection Control: Cross-Sectional Study Among Jordanian Dentists. JMIR Public Health Surveill. 2020 Apr 9;6(2):e18798. doi: 10.2196/18798.
PMID: 32250959
citation: Asiry MA. Dental students' perceptions of an online learning. Saudi Dent J. 2017 Oct;29(4):167-170. doi: 10.1016/j.sdentj.2017.03.005. Epub 2017 Aug 2.
PMID: 29033527
responsible party type: Principal Investigator
investigator affiliation: Melaka Manipal Medical College
investigator full name: Rajesh Hosadurga
investigator title: Professor
mesh term: Infections
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Myalgia
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Dyspnea
mesh term: Lung Injury
sharing ipd: No
ipd description: No personal details of the participant will be shared.