<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/NCT04444557</url>
  </required_header>
  <id_info>
    <org_study_id>200620</org_study_id>
    <nct_id>NCT04444557</nct_id>
  </id_info>
  <brief_title>Effect of COvid-19 on Mental Health in Syrian and Turkish Maintenance HemoDialysis Patients: COST-HD Study</brief_title>
  <acronym>COST-HD</acronym>
  <official_title>Effect of COvid-19 on Mental Health in Syrian and Turkish Maintenance HemoDialysis Patients: COST-HD Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research Hospital</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>
      SARS-COV infection first has begun at Wuhan, China, and then became a pandemic. The first&#xD;
      COVID-19 case has been reported on March 11, 2020, in Turkey. People older than 65 years old&#xD;
      have been locked down on March 21 and people younger than 20 years old locked down at April&#xD;
      03. A total lockdown has been done a few times lasting for 3 or 4 days, especially at&#xD;
      weekends.&#xD;
&#xD;
      Renal replacement modalities have been affected in different ways during the pandemic.&#xD;
      Patients with kidney transplantation and patients performing home hemodialysis or peritoneal&#xD;
      dialysis have been advised to perform self-isolation at homes. However, center hemodialysis&#xD;
      patients continued to come dialysis centers obligatorily.&#xD;
&#xD;
      Syrian civil war has been continuing since 2011, and Turkey has accepted millions of Syrian&#xD;
      people in a position called temporary protection. There are many Syrian center hemodialysis&#xD;
      patients both in Turkey and in our unit. The investigators do not know if pandemic affected&#xD;
      Syrian patients different than Turkish ones. The aim of this study is to compare beck&#xD;
      depression scores of Turkish and Syrian patients undergoing hemodialysis during the COVID-19&#xD;
      pandemic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2020</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Score of Beck Depression Inventory</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Total score of Beck Depression Inventory (Minimin score: 0, Maximum score: 63; higher scores mean worse outcome)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">97</enrollment>
  <condition>Depression</condition>
  <condition>Hemodialysis</condition>
  <arm_group>
    <arm_group_label>Turkish hemodialysis patients</arm_group_label>
    <description>Turkish patients undergoing in-center hemodialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Temporarily protected Syrian hemodialysis patients</arm_group_label>
    <description>Temporarily protected Syrian patients undergoing in-center hemodialysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Beck Depression Inventory (BDI)</intervention_name>
    <description>The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression</description>
    <arm_group_label>Temporarily protected Syrian hemodialysis patients</arm_group_label>
    <arm_group_label>Turkish hemodialysis patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing in-center hemodialysis in Sisli Hamidiye Etfal Training and&#xD;
        Research hospital (22 patients excluded from the study in accordance with exclusion&#xD;
        criteria)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old&#xD;
&#xD;
          -  Hemodialysis history of more than three months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who can not speak Turkish or Arabic,&#xD;
&#xD;
          -  Not volunteer to fill the form&#xD;
&#xD;
          -  History of hospitalization for any reason during the pandemic time,&#xD;
&#xD;
          -  History of COVID-19 before the questionnaire (Beck Depression Inventory)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mustafa Sevinc, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sisli Hamidiye Etfal Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sisli Hamidiye Etfal Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Nuri Baris Hasbal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>hemodialysis</keyword>
  <keyword>depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>If requested, IPD 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/NCT04444557
org study id: 200620
nct id: NCT04444557
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SARS-COV infection first has begun at Wuhan, China, and then became a pandemic. The first
      COVID-19 case has been reported on March 11, 2020, in Turkey. People older than 65 years old
      have been locked down on March 21 and people younger than 20 years old locked down at April
      03. A total lockdown has been done a few times lasting for 3 or 4 days, especially at
      weekends.

      Renal replacement modalities have been affected in different ways during the pandemic.
      Patients with kidney transplantation and patients performing home hemodialysis or peritoneal
      dialysis have been advised to perform self-isolation at homes. However, center hemodialysis
      patients continued to come dialysis centers obligatorily.

      Syrian civil war has been continuing since 2011, and Turkey has accepted millions of Syrian
      people in a position called temporary protection. There are many Syrian center hemodialysis
      patients both in Turkey and in our unit. The investigators do not know if pandemic affected
      Syrian patients different than Turkish ones. The aim of this study is to compare beck
      depression scores of Turkish and Syrian patients undergoing hemodialysis during the COVID-19
      pandemic.
observational model: Cohort
time perspective: Prospective
measure: Score of Beck Depression Inventory
time frame: through study completion, an average of 6 months
description: Total score of Beck Depression Inventory (Minimin score: 0, Maximum score: 63; higher scores mean worse outcome)
arm group label: Turkish hemodialysis patients
description: Turkish patients undergoing in-center hemodialysis
arm group label: Temporarily protected Syrian hemodialysis patients
description: Temporarily protected Syrian patients undergoing in-center hemodialysis
intervention type: Other
intervention name: Beck Depression Inventory (BDI)
description: The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
arm group label: Temporarily protected Syrian hemodialysis patients
arm group label: Turkish hemodialysis patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mustafa Sevinc, MD
role: Principal Investigator
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Nuri Baris Hasbal
investigator title: Principal Investigator
mesh term: Depression
sharing ipd: Undecided
ipd description: If requested, IPD will be shared