<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/NCT03235895</url>
  </required_header>
  <id_info>
    <org_study_id>nccam_1_2017</org_study_id>
    <nct_id>NCT03235895</nct_id>
  </id_info>
  <brief_title>Evaluation of Internet-Based CME for Wet-cupping Providers</brief_title>
  <official_title>Evaluation of Internet-Based CME for Wet-cupping Providers: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Center for Complementary and Alternative Medicine, Saudi Arabia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Center for Complementary and Alternative Medicine, Saudi Arabia</source>
  <oversight_info>
    <has_dmc>No</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>
      A randomized controlled Trial to evaluate the internet based CME for wet cupping providers in&#xD;
      Saudi Arabia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research problem:&#xD;
&#xD;
      Complementary and Alternative Medicine (CAM) is widely used in Saudi Arabia. As wet-cupping&#xD;
      practice regulation and licensing had been established the need increased to develop a system&#xD;
      of Continuing Medical Education (CME) for wet-cupping providers. E-learning grown steadily to&#xD;
      become a popular approach in medical education with the fast-evolving technologies made it&#xD;
      possible to develop and implement a high-quality Internet-based CME. The aim of this study is&#xD;
      to compare the effectiveness of Internet-based CME with conventional CME in the field of&#xD;
      complementary medicine.&#xD;
&#xD;
      Research Significance:&#xD;
&#xD;
      Aiming to control the training to guarantee evidenced-based quality care while facing the&#xD;
      challenge of increased number of licensed cupping providers who needs CME hours to maintain&#xD;
      and improve their practice. There is a need for a study to evaluate if the internet-based&#xD;
      technique can help overcome the challenge and to increase the number and improve the quality&#xD;
      of CME activities.&#xD;
&#xD;
      Research Objectives:&#xD;
&#xD;
      To evaluate the effect of internet-based CME activity on knowledge, knowledge retention and&#xD;
      intellectual skills in wet-cupping providers compared with conventional CME activity.&#xD;
      Moreover, to develop a model of a blended CME activity using the online platform to conduct a&#xD;
      flipping classroom CME activity in complementary medicine.&#xD;
&#xD;
      Research Methodology:&#xD;
&#xD;
      Randomised, open, comparative controlled trial. Participants will be selected from a list of&#xD;
      the registered cupping providers. Using a list of registered cupping providers (sample frame)&#xD;
      a sample will be selected randomly using computer generated number. After taking informed&#xD;
      consent participants will be allocated randomly into three groups; 1) Internet-based CME&#xD;
      activity group; 2) Conventional CME activity group, and 3) control group (waitlist) receiving&#xD;
      no intervention. Data will be explored for distribution, and the appropriate methods of&#xD;
      presentation and testing of differences will be selected accordingly. Two-tailed values of&#xD;
      p&lt;0.05 will be considered statistically significant. Immediate knowledge score, Retention&#xD;
      Knowledge rate and skills score will be compared within and between the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 25, 2017</start_date>
  <completion_date type="Anticipated">December 10, 2017</completion_date>
  <primary_completion_date type="Anticipated">November 25, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge score</measure>
    <time_frame>Day 0 and day 7</time_frame>
    <description>To measure the change the knowledge score within and between the internet-based CME group, the conventional CME group, and the control group before and immediately after the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge score</measure>
    <time_frame>Day 7 and day 14</time_frame>
    <description>to asses the change in knowledge score knowledge between day 7 and day 14</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Educational Problems</condition>
  <arm_group>
    <arm_group_label>Internet based</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six days of Instructional online CME educational material using Test-Enhanced E-Learning strategy.&#xD;
Followed by one day face to face CME activity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Face to Face</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three days face to face Conventional CME educational materials</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait listed</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No CME activity will be given</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational material</intervention_name>
    <description>Educational material given as a part of CME activity as through enhanced internet method</description>
    <arm_group_label>Face to Face</arm_group_label>
    <arm_group_label>Internet based</arm_group_label>
    <other_name>CME</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physicians, nurses, physiotherapists&#xD;
&#xD;
          -  Passed the Compulsory wet cupping training course within the last three years.&#xD;
&#xD;
          -  Available during the study periods.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unaccredited wet cupping training courses.&#xD;
&#xD;
          -  Accredit courses more than three Years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moahmed Khalil, MD</last_name>
    <role>Study Chair</role>
    <affiliation>National Center for Complmentary and Alternative Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abdullah AlMudiaheem, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Center for Complmentary and Alternative Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nasser Al-Hamdan</last_name>
    <role>Study Director</role>
    <affiliation>College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed K Khalil, MD</last_name>
    <phone>00966504955087</phone>
    <email>statkhl@hotmail.com</email>
  </overall_contact>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 30, 2017</last_update_submitted>
  <last_update_submitted_qc>July 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</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>


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/NCT03235895
org study id: nccam_1_2017
nct id: NCT03235895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized controlled Trial to evaluate the internet based CME for wet cupping providers in
      Saudi Arabia
Research problem:

      Complementary and Alternative Medicine (CAM) is widely used in Saudi Arabia. As wet-cupping
      practice regulation and licensing had been established the need increased to develop a system
      of Continuing Medical Education (CME) for wet-cupping providers. E-learning grown steadily to
      become a popular approach in medical education with the fast-evolving technologies made it
      possible to develop and implement a high-quality Internet-based CME. The aim of this study is
      to compare the effectiveness of Internet-based CME with conventional CME in the field of
      complementary medicine.

      Research Significance:

      Aiming to control the training to guarantee evidenced-based quality care while facing the
      challenge of increased number of licensed cupping providers who needs CME hours to maintain
      and improve their practice. There is a need for a study to evaluate if the internet-based
      technique can help overcome the challenge and to increase the number and improve the quality
      of CME activities.

      Research Objectives:

      To evaluate the effect of internet-based CME activity on knowledge, knowledge retention and
      intellectual skills in wet-cupping providers compared with conventional CME activity.
      Moreover, to develop a model of a blended CME activity using the online platform to conduct a
      flipping classroom CME activity in complementary medicine.

      Research Methodology:

      Randomised, open, comparative controlled trial. Participants will be selected from a list of
      the registered cupping providers. Using a list of registered cupping providers (sample frame)
      a sample will be selected randomly using computer generated number. After taking informed
      consent participants will be allocated randomly into three groups; 1) Internet-based CME
      activity group; 2) Conventional CME activity group, and 3) control group (waitlist) receiving
      no intervention. Data will be explored for distribution, and the appropriate methods of
      presentation and testing of differences will be selected accordingly. Two-tailed values of
      p<0.05 will be considered statistically significant. Immediate knowledge score, Retention
      Knowledge rate and skills score will be compared within and between the groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Knowledge score
time frame: Day 0 and day 7
description: To measure the change the knowledge score within and between the internet-based CME group, the conventional CME group, and the control group before and immediately after the intervention
measure: Knowledge score
time frame: Day 7 and day 14
description: to asses the change in knowledge score knowledge between day 7 and day 14
arm group label: Internet based
arm group type: Experimental
description: Six days of Instructional online CME educational material using Test-Enhanced E-Learning strategy.
Followed by one day face to face CME activity
arm group label: Face to Face
arm group type: Active Comparator
description: Three days face to face Conventional CME educational materials
arm group label: Wait listed
arm group type: No Intervention
description: No CME activity will be given
intervention type: Other
intervention name: Educational material
description: Educational material given as a part of CME activity as through enhanced internet method
arm group label: Face to Face
arm group label: Internet based
other name: CME
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Moahmed Khalil, MD
role: Study Chair
affiliation: National Center for Complmentary and Alternative Medicine
last name: Abdullah AlMudiaheem, MBBS
role: Principal Investigator
affiliation: National Center for Complmentary and Alternative Medicine
last name: Nasser Al-Hamdan
role: Study Director
affiliation: College of Medicine
last name: Mohamed K Khalil, MD
phone: 00966504955087
email: statkhl@hotmail.com
responsible party type: Sponsor
sharing ipd: No