<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/NCT04407299</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19Rheum</org_study_id>
    <nct_id>NCT04407299</nct_id>
  </id_info>
  <brief_title>COVID-19 Impact on Rheumatic Patients</brief_title>
  <official_title>Impact of COVID-19 Pandemic on Attitude, Behaviour and Mental Health of Patients With Rheumatic Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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 study to assess the impact of coronavirus disease 2019 (COVID-19) pandemic on the attitude,&#xD;
      behaviour and mental health of rheumatic patients and to compare them with healthy&#xD;
      individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the impact of coronavirus disease 2019 (COVID19) pandemic on the attitude,&#xD;
      behaviour and mental health of rheumatic patients and to compare them with healthy&#xD;
      individual. This is cross-sectional survey, 360 participants were included and divided into&#xD;
      cases group composed of 180 patients with rheumatic diseases and control group composed of&#xD;
      180 healthy people. Data were collected via a self-administered structured questionnaire&#xD;
      (Google form) which was sent to participants via social networks and emails to different&#xD;
      rheumatic patients and healthy individuals. Mental health was measured by the five-item Brief&#xD;
      Symptom Rating Scale (BSRS-5).&#xD;
&#xD;
      Conclusion: Mental health should be addressed in the same manner we deal with the infectious&#xD;
      disease itself, being of no less importance. It is essential for mental health professionals&#xD;
      provide psychological support to vulnerable populations, including the infected and&#xD;
      chronically ill patients and their families, individuals, communities and health care&#xD;
      workers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2020</start_date>
  <completion_date type="Actual">May 20, 2020</completion_date>
  <primary_completion_date type="Actual">May 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Score of five-item Brief Symptom Rating Scale (BSRS-5)</measure>
    <time_frame>3 weeks</time_frame>
    <description>7. Six questions for mental health assessment for patients and controls: Mental health was measured by the five-item Brief Symptom Rating Scale (BSRS-5) which was derived from the 50-item BSRS</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">360</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>180 patients diagnosed with autoimmune rheumatic disease. Patients are RA SLE Rhupus AS Behcet Sjogren Vasculitis FM Polymyalgia APA Sarcoidosis IBD Scleroderma DM PSA Mixed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>control group composed of 180 healthy individuals (matched for age and sex)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>self-administered structured questionnaire</intervention_name>
    <description>It was designed as a self-administered questionnaire with closed questions (yes/no questions, rating scale and multiple choice questions) and some open ended questions.</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        a total of 360 participants were included in this study and divided into two groups: cases&#xD;
        group composed of 180 patients with rheumatic diseases and control group composed of 180&#xD;
        healthy individuals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patient with diagnosed rheumatic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mervat Eissa</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr Alainy Hospital</name>
      <address>
        <city>Cairo</city>
        <state>Non-US/Non-Canadian</state>
        <zip>15551</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mervat Eissa</investigator_full_name>
    <investigator_title>Associate Prpfessor</investigator_title>
  </responsible_party>
  <keyword>Rheumatic patients</keyword>
  <keyword>COVID-19</keyword>
  <keyword>behaviour</keyword>
  <keyword>Mental health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Rheumatic Diseases</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/NCT04407299
org study id: COVID-19Rheum
nct id: NCT04407299
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A study to assess the impact of coronavirus disease 2019 (COVID-19) pandemic on the attitude,
      behaviour and mental health of rheumatic patients and to compare them with healthy
      individuals.
To assess the impact of coronavirus disease 2019 (COVID19) pandemic on the attitude,
      behaviour and mental health of rheumatic patients and to compare them with healthy
      individual. This is cross-sectional survey, 360 participants were included and divided into
      cases group composed of 180 patients with rheumatic diseases and control group composed of
      180 healthy people. Data were collected via a self-administered structured questionnaire
      (Google form) which was sent to participants via social networks and emails to different
      rheumatic patients and healthy individuals. Mental health was measured by the five-item Brief
      Symptom Rating Scale (BSRS-5).

      Conclusion: Mental health should be addressed in the same manner we deal with the infectious
      disease itself, being of no less importance. It is essential for mental health professionals
      provide psychological support to vulnerable populations, including the infected and
      chronically ill patients and their families, individuals, communities and health care
      workers.
observational model: Other
time perspective: Cross-Sectional
measure: Score of five-item Brief Symptom Rating Scale (BSRS-5)
time frame: 3 weeks
description: 7. Six questions for mental health assessment for patients and controls: Mental health was measured by the five-item Brief Symptom Rating Scale (BSRS-5) which was derived from the 50-item BSRS
arm group label: 1
description: 180 patients diagnosed with autoimmune rheumatic disease. Patients are RA SLE Rhupus AS Behcet Sjogren Vasculitis FM Polymyalgia APA Sarcoidosis IBD Scleroderma DM PSA Mixed
arm group label: 2
description: control group composed of 180 healthy individuals (matched for age and sex)
intervention type: Behavioral
intervention name: self-administered structured questionnaire
description: It was designed as a self-administered questionnaire with closed questions (yes/no questions, rating scale and multiple choice questions) and some open ended questions.
arm group label: 1
arm group label: 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
last name: Mervat Eissa
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mervat Eissa
investigator title: Associate Prpfessor
mesh term: COVID-19
mesh term: Rheumatic Diseases
sharing ipd: No