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/NCT05991635</url>
    </required_header>
    <id_info>
      <org_study_id>ONZ-2022-0598</org_study_id>
      <nct_id>NCT05991635</nct_id>
    </id_info>
    <brief_title>Evaluation of a Gatekeeper Training for Pharmacists</brief_title>
    <official_title>Evaluation of a Gatekeeper Training for Pharmacists</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Ghent</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Ghent</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>
        This study aims to investigate to what extent a gatekeeper training (e-learning) for&#xD;
        pharmacists and PTA is effective in changing the attitudes, knowledge, and self-efficacy.&#xD;
        Moreover, it aims to examine how they evaluate the training and whether they were able to&#xD;
        apply the learned skills in practice.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 12, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in attitudes: Attitudes Towards Suicide Scale (ATTS)</measure>
      <time_frame>Change from Baseline (before intervention) to post-test (after a week of access to e-learning)</time_frame>
      <description>The ATTS is a 37-item to be scored on a 5-point Likert scale (1= disagree completely to 5 = agree completely) to measure participants' attitudes towards suicide.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in self-efficacy: Measurement of Perceived Self-efficacy</measure>
      <time_frame>Change from Baseline (before intervention) to post-test (after a week of access to e-learning)</time_frame>
      <description>The Measurement of Perceived Self-efficacy is a 10-item self-report questionnaire to be scored on a 4-point Likert scale (1= Completely false to 4 = completely true)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in perceptions/myths</measure>
      <time_frame>Change from Baseline (before intervention) to post-test (after a week of access to e-learning)</time_frame>
      <description>Self-developped questionnaire: 4 statements to be rated as true or false; 2 question about how participant would feel if a patient said they have suicidal thouhgts</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gatekeeper training evaluation</measure>
      <time_frame>Post-test (after a week of access to e-learning)</time_frame>
      <description>8 evaluative statements about the e-learning to be rated on a 5-point Likert scale (Totally disagree, disagree, neutral, agree, totally disagree).&#xD;
  Question to rate the e-learning on a scale of 1 (not good at all) to 10 (excellent) Additionally three open questions where participants can give feedback about what they liked/did not like/ general comments.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Socio-demographic characteristics</measure>
      <time_frame>Baseline</time_frame>
      <description>Age, Gender, Years of work experience</description>
    </other_outcome>
    <other_outcome>
      <measure>Previous experience with suicide (prevention)</measure>
      <time_frame>Baseline and post-test (after a week of access to e-learning)</time_frame>
      <description>At baseline: motivation to participate (9 options), previous trainings (yes/no, specify if yes) At baseline and post-test: experience with suicidal patients (contact and confidence; 5 point Likert scale), knowing what to do or who to refer to (5-point Likert scale), knowing where to find information (5-point Likert scale), which actions previously taken in case of suicidal patient (list of 12), to who do you refer (5 options)</description>
    </other_outcome>
    <other_outcome>
      <measure>Follow-up</measure>
      <time_frame>Follow-up (three months after baseline)</time_frame>
      <description>Questions concerning: application of acquired skills and knowledge; actions undertaken in context of suicide prevention (12 options); experienced barriers to application of acquired skills and knowledge; need of extra support</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">114</enrollment>
    <condition>Suicide</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group (all participants) are asked to complete a questionnaire and then receive access to the online gatekeeper training (e-learning) during three days, after which they were asked to complete another questionnaire. After three months, a third questionnaire is sent.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Gatekeeper training (e-learning)</intervention_name>
      <description>The gatekeeper training consists of an interactive e-learning (min. 1h, max. 3h) which includes theoretical knowledge, tips, exercises and relevant examples and cases. The main topics included in the e-learning are:&#xD;
  Background information on suicide in Flanders (rates)&#xD;
  Definitions and theoretical background (suicidal process, integrative explanatory model of suicide)&#xD;
  Debunking existing myths about suicide&#xD;
  The role of the pharmacist in suicide prevention&#xD;
  Signal Recognition&#xD;
  Talking about suicide and suicidal thoughts (start the conversation)&#xD;
  How and to whom to refer as pharmacist or FTA&#xD;
  Medication management and medication in the context of suicide&#xD;
  Rights and obligations of a pharmacist/PTA in the context of suicide prevention&#xD;
  Self-care</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥ 18 years old&#xD;
  &#xD;
            -  Have access to internet&#xD;
  &#xD;
            -  Speak Dutch&#xD;
  &#xD;
            -  Working as a (public) pharmacist or pharmaceutical technical assistant (FTA)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hospital pharmacists or industrial pharmacists are not included in this study and thus&#xD;
               constitute an exclusion criterion.&#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>Gwendolyn Portzky, Phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Ghent</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eva De Jaegere</last_name>
      <phone>+32 (0)9 332.07.75</phone>
      <email>eva.dejaegere@ugent.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pauline Stas</last_name>
      <phone>+32 (0)9 332.07.75</phone>
      <email>pauline.stas@ugent.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Flemish Centre of Expertise in Suicide Prevention, Ghent University</name>
        <address>
          <city>Ghent</city>
          <zip>9000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eva De Jaegere, MSc</last_name>
        <phone>+3293320775</phone>
        <email>eva.dejaegere@ugent.be</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>Suicide</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/NCT05991635
  org study id: ONZ-2022-0598
  nct id: NCT05991635
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to investigate to what extent a gatekeeper training (e-learning) for
        pharmacists and PTA is effective in changing the attitudes, knowledge, and self-efficacy.
        Moreover, it aims to examine how they evaluate the training and whether they were able to
        apply the learned skills in practice.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Changes in attitudes: Attitudes Towards Suicide Scale (ATTS)
  time frame: Change from Baseline (before intervention) to post-test (after a week of access to e-learning)
  description: The ATTS is a 37-item to be scored on a 5-point Likert scale (1= disagree completely to 5 = agree completely) to measure participants' attitudes towards suicide.
  measure: Changes in self-efficacy: Measurement of Perceived Self-efficacy
  time frame: Change from Baseline (before intervention) to post-test (after a week of access to e-learning)
  description: The Measurement of Perceived Self-efficacy is a 10-item self-report questionnaire to be scored on a 4-point Likert scale (1= Completely false to 4 = completely true)
  measure: Changes in perceptions/myths
  time frame: Change from Baseline (before intervention) to post-test (after a week of access to e-learning)
  description: Self-developped questionnaire: 4 statements to be rated as true or false; 2 question about how participant would feel if a patient said they have suicidal thouhgts
  measure: Gatekeeper training evaluation
  time frame: Post-test (after a week of access to e-learning)
  description: 8 evaluative statements about the e-learning to be rated on a 5-point Likert scale (Totally disagree, disagree, neutral, agree, totally disagree).
  Question to rate the e-learning on a scale of 1 (not good at all) to 10 (excellent) Additionally three open questions where participants can give feedback about what they liked/did not like/ general comments.
  measure: Socio-demographic characteristics
  time frame: Baseline
  description: Age, Gender, Years of work experience
  measure: Previous experience with suicide (prevention)
  time frame: Baseline and post-test (after a week of access to e-learning)
  description: At baseline: motivation to participate (9 options), previous trainings (yes/no, specify if yes) At baseline and post-test: experience with suicidal patients (contact and confidence; 5 point Likert scale), knowing what to do or who to refer to (5-point Likert scale), knowing where to find information (5-point Likert scale), which actions previously taken in case of suicidal patient (list of 12), to who do you refer (5 options)
  measure: Follow-up
  time frame: Follow-up (three months after baseline)
  description: Questions concerning: application of acquired skills and knowledge; actions undertaken in context of suicide prevention (12 options); experienced barriers to application of acquired skills and knowledge; need of extra support
  arm group label: Intervention group
  arm group type: Experimental
  description: Participants in this group (all participants) are asked to complete a questionnaire and then receive access to the online gatekeeper training (e-learning) during three days, after which they were asked to complete another questionnaire. After three months, a third questionnaire is sent.
  intervention type: Behavioral
  intervention name: Gatekeeper training (e-learning)
  description: The gatekeeper training consists of an interactive e-learning (min. 1h, max. 3h) which includes theoretical knowledge, tips, exercises and relevant examples and cases. The main topics included in the e-learning are:
  Background information on suicide in Flanders (rates)
  Definitions and theoretical background (suicidal process, integrative explanatory model of suicide)
  Debunking existing myths about suicide
  The role of the pharmacist in suicide prevention
  Signal Recognition
  Talking about suicide and suicidal thoughts (start the conversation)
  How and to whom to refer as pharmacist or FTA
  Medication management and medication in the context of suicide
  Rights and obligations of a pharmacist/PTA in the context of suicide prevention
  Self-care
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gwendolyn Portzky, Phd
  role: Principal Investigator
  affiliation: University Ghent
  last name: Eva De Jaegere
  phone: +32 (0)9 332.07.75
  email: eva.dejaegere@ugent.be
  last name: Pauline Stas
  phone: +32 (0)9 332.07.75
  email: pauline.stas@ugent.be
  facility: 
  status: Recruiting
  contact: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Suicide
  sharing ipd: No