<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/NCT04448418</url>
  </required_header>
  <id_info>
    <org_study_id>TRANSCOVID-19</org_study_id>
    <nct_id>NCT04448418</nct_id>
  </id_info>
  <brief_title>The Impact of COVID-19 Outbreak on Trans-population's Health in Italy</brief_title>
  <official_title>Observational Evaluation of the Impact of COVID-19 Outbreak on Transgender Subject's Health and on the Organization of Trans-population Health Care Services</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unita Complessa di Ostetricia e Ginecologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unita Complessa di Ostetricia e Ginecologia</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>
      During the COVID-19 outbreak, it was necessary to remodel the healthcare offer for all&#xD;
      categories of subjects in order to minimize unnecessary movements of people while maintaining&#xD;
      an adequate level of assistance. This is also true for transgender people, who are&#xD;
      periodically requested to come into the clinic for hormonal therapy monitoring and&#xD;
      continuation. In our center telemedicine programs dedicated to users have been activated for&#xD;
      the remote management of hormone therapy.&#xD;
&#xD;
      We use a web-based survey to assess the impact of COVID-19 outbreak on trans-population&#xD;
      health and to assess the specific needs of this population in this particular moment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Use of a dedicated web-based anonymous questionnaire to assess health needs of&#xD;
      trans-population during COVID-19 outbreak and to assess specific risk factors for COVID-19&#xD;
      infection.&#xD;
&#xD;
      Evaluation of physical and psychological wellbeing of the trans-population during COIVD-19&#xD;
      outbreak in Italy using anonymous validated questionnaires (SF12, IES-R and BECK DEPRESSION&#xD;
      INVENTORY)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 20, 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>Assessment of the specific health need of the transpopulation during the COVID-19 pandemic in Italy</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Evaluation of the specific health care needs of this population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of risk factors for COVID-19 infection in the traspopulation</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Evaluation of socioeconomical and working condition of this population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Use of a web based questionnaire to assess satisfaction with health care with a 0-10 scale (0=no satisfaction to 10=high satisfaction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the psychological wellbeing of the trans-population during COVID-19 outbreak in Italy</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Use of web based validated questionnaire: Impact of Event Scale-Revised (in Italian) to investigate perception of the COVID-19 event and subjects' mood. The scale is a self-report measure of current subjective distress in response to a specific traumatic event. Minimum score=0, maximum score=60, higher scores correspond to a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Use of web based validated questionnaire: Beck Depression Inventory to investigate mood. The 21 symptoms and attitudes contained in the questionnaire reflect the severity of the depression; the final score ranges from 0 to 63, with worse outcome with higher values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Use of web based validated questionnaire: Short Form 2, to assess the impact of health on an individual's everyday life. The SF-12 is made of an eight-scale profile of scores as well as physical and mental health summary measures. Total scores range from 16 to 47 with worse outcomes for lower scores.</description>
  </secondary_outcome>
  <enrollment type="Actual">111</enrollment>
  <condition>Transgender Persons</condition>
  <condition>Coronavirus</condition>
  <condition>Coronavirus Infection</condition>
  <condition>COVID</condition>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>web based survey</intervention_name>
    <description>Assess specific health care needs for the transpopulation during the COVID-19 outbreack using a newly created questionnaire and some validated questionnaries (Impact of Event Scale-Revised, BECK Depression Inventory and the Self-rated Health SF-12)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        transgender population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  transgender subjects&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>1Gynecology and Physiopathology of Human Reproduction, S. Orsola-Malpighi Hospital, Department of Medical and Surgical Sciences (DIMEC), University of Bologna</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Unita Complessa di Ostetricia e Ginecologia</investigator_affiliation>
    <investigator_full_name>maria cristina meriggiola</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <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/NCT04448418
org study id: TRANSCOVID-19
nct id: NCT04448418
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During the COVID-19 outbreak, it was necessary to remodel the healthcare offer for all
      categories of subjects in order to minimize unnecessary movements of people while maintaining
      an adequate level of assistance. This is also true for transgender people, who are
      periodically requested to come into the clinic for hormonal therapy monitoring and
      continuation. In our center telemedicine programs dedicated to users have been activated for
      the remote management of hormone therapy.

      We use a web-based survey to assess the impact of COVID-19 outbreak on trans-population
      health and to assess the specific needs of this population in this particular moment.
Use of a dedicated web-based anonymous questionnaire to assess health needs of
      trans-population during COVID-19 outbreak and to assess specific risk factors for COVID-19
      infection.

      Evaluation of physical and psychological wellbeing of the trans-population during COIVD-19
      outbreak in Italy using anonymous validated questionnaires (SF12, IES-R and BECK DEPRESSION
      INVENTORY)
observational model: Cohort
time perspective: Cross-Sectional
measure: Assessment of the specific health need of the transpopulation during the COVID-19 pandemic in Italy
time frame: through study completion, an average of 6 months
description: Evaluation of the specific health care needs of this population
measure: Assessment of risk factors for COVID-19 infection in the traspopulation
time frame: through study completion, an average of 6 months
description: Evaluation of socioeconomical and working condition of this population
measure: Evaluation of the satisfaction of this population with telemedicine for hormonal treatment monitoring
time frame: through study completion, an average of 6 months
description: Use of a web based questionnaire to assess satisfaction with health care with a 0-10 scale (0=no satisfaction to 10=high satisfaction)
measure: Evaluation of the psychological wellbeing of the trans-population during COVID-19 outbreak in Italy
time frame: through study completion, an average of 6 months
description: Use of web based validated questionnaire: Impact of Event Scale-Revised (in Italian) to investigate perception of the COVID-19 event and subjects' mood. The scale is a self-report measure of current subjective distress in response to a specific traumatic event. Minimum score=0, maximum score=60, higher scores correspond to a worse outcome.
measure: Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy
time frame: through study completion, an average of 6 months
description: Use of web based validated questionnaire: Beck Depression Inventory to investigate mood. The 21 symptoms and attitudes contained in the questionnaire reflect the severity of the depression; the final score ranges from 0 to 63, with worse outcome with higher values.
measure: Evaluation of the psychological and physical wellbeing of the trans-population during COVID-19 outbreak in Italy
time frame: through study completion, an average of 6 months
description: Use of web based validated questionnaire: Short Form 2, to assess the impact of health on an individual's everyday life. The SF-12 is made of an eight-scale profile of scores as well as physical and mental health summary measures. Total scores range from 16 to 47 with worse outcomes for lower scores.
intervention type: Other
intervention name: web based survey
description: Assess specific health care needs for the transpopulation during the COVID-19 outbreack using a newly created questionnaire and some validated questionnaries (Impact of Event Scale-Revised, BECK Depression Inventory and the Self-rated Health SF-12)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Unita Complessa di Ostetricia e Ginecologia
investigator full name: maria cristina meriggiola
investigator title: Professor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No