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/NCT05987553</url>
    </required_header>
    <id_info>
      <org_study_id>2020-1334</org_study_id>
      <nct_id>NCT05987553</nct_id>
    </id_info>
    <brief_title>The Influence of an E-learning Program on Recognition of Actinic Keratosis</brief_title>
    <official_title>The Influence of an E-learning Program on Recognition of Actinic Keratosis by General Practitioners). Implementation of Actinic Keratosis Guidelines Among General Practitioners.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maastricht University Medical Center</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>
        The evaluation on the diagnostic accuracy of actinic keratosis recognition by general&#xD;
        practitioners before and after participation on an e-learning program.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Actinic keratosis is defined as the most frequent common intra-epithelial neoplasm in the&#xD;
        Caucasian population, with an increasing prevalence. If left untreated, actinic keratosis has&#xD;
        the potency to develop into a cutaneous squamous-cell carcinoma. Treatment of actinic&#xD;
        keratosis is aimed at both lesion reduction and to prevent malignant transformation. To&#xD;
        achieve treatment adherence for patients, it is necessary to raise physician awareness about&#xD;
        actinic keratosis.&#xD;
  &#xD;
        This study primarily aimed to investigate whether the sensitivity of establishing a correct&#xD;
        actinic keratosis diagnosis by general practitioners (in training) would increase after&#xD;
        participating in an e-learning program about the recognition of actinic keratosis. This was&#xD;
        achieved by comparing the results of a pre- and post-test completed by general practitioners&#xD;
        which was incorporated in the e-learning program.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Difference in sensitivity</measure>
      <time_frame>Measurement by baseline and after finalising the e-learning program (same day up until 30 days)</time_frame>
      <description>Difference in sensitivity of participants in the recognition of actinic keratosis, before and after the use of an e-learning program (paired).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Difference in specificity</measure>
      <time_frame>Measurement by baseline and after finalising the e-learning program (same day up until 30 days)</time_frame>
      <description>Difference in specificity of participants in the recognition of actinic keratosis, before and after the use of an e-learning program (paired).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in area under the receiver operating characteristic (ROC) curve</measure>
      <time_frame>Measurement by baseline and after finalising the e-learning program (same day up until 30 days)</time_frame>
      <description>Difference in area under the curve of participants in the recognition of actinic keratosis, before and after the use of an e-learning program.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">32</enrollment>
    <condition>Actinic Keratoses</condition>
    <condition>E-learning</condition>
    <condition>Dermatology</condition>
    <arm_group>
      <arm_group_label>General practitioners</arm_group_label>
      <description>All participants were general practitioners (in training).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>e-learning program</intervention_name>
      <description>All participants participate in this intervention: an e-learning program about the recognition of actinic keratosis. The program exists of 30 cases. Each case exists of a question and thorough explanation including references to various sources.</description>
      <arm_group_label>General practitioners</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Data from general practitioners who&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  general practitioner in the Netherlands&#xD;
  &#xD;
            -  access to e-learning module via phone/computer/tablet&#xD;
  &#xD;
            -  knowledge of the Dutch language&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  no knowledge of the Dutch language&#xD;
  &#xD;
            -  different specialists than general practitioner&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>67 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Klara Mosterd, prof.dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maastricht UMC+</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ellen Oyen</name>
        <address>
          <city>Maastricht</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Keratosis, Actinic</mesh_term>
      <mesh_term>Keratosis</mesh_term>
    </condition_browse>
    <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/NCT05987553
  org study id: 2020-1334
  nct id: NCT05987553
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The evaluation on the diagnostic accuracy of actinic keratosis recognition by general
        practitioners before and after participation on an e-learning program.
  Actinic keratosis is defined as the most frequent common intra-epithelial neoplasm in the
        Caucasian population, with an increasing prevalence. If left untreated, actinic keratosis has
        the potency to develop into a cutaneous squamous-cell carcinoma. Treatment of actinic
        keratosis is aimed at both lesion reduction and to prevent malignant transformation. To
        achieve treatment adherence for patients, it is necessary to raise physician awareness about
        actinic keratosis.
  
        This study primarily aimed to investigate whether the sensitivity of establishing a correct
        actinic keratosis diagnosis by general practitioners (in training) would increase after
        participating in an e-learning program about the recognition of actinic keratosis. This was
        achieved by comparing the results of a pre- and post-test completed by general practitioners
        which was incorporated in the e-learning program.
  observational model: Cohort
  time perspective: Prospective
  measure: Difference in sensitivity
  time frame: Measurement by baseline and after finalising the e-learning program (same day up until 30 days)
  description: Difference in sensitivity of participants in the recognition of actinic keratosis, before and after the use of an e-learning program (paired).
  measure: Difference in specificity
  time frame: Measurement by baseline and after finalising the e-learning program (same day up until 30 days)
  description: Difference in specificity of participants in the recognition of actinic keratosis, before and after the use of an e-learning program (paired).
  measure: Difference in area under the receiver operating characteristic (ROC) curve
  time frame: Measurement by baseline and after finalising the e-learning program (same day up until 30 days)
  description: Difference in area under the curve of participants in the recognition of actinic keratosis, before and after the use of an e-learning program.
  arm group label: General practitioners
  description: All participants were general practitioners (in training).
  intervention type: Other
  intervention name: e-learning program
  description: All participants participate in this intervention: an e-learning program about the recognition of actinic keratosis. The program exists of 30 cases. Each case exists of a question and thorough explanation including references to various sources.
  arm group label: General practitioners
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 67 Years
  last name: Klara Mosterd, prof.dr.
  role: Principal Investigator
  affiliation: Maastricht UMC+
  facility: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Keratosis, Actinic
  mesh term: Keratosis
  sharing ipd: No