<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/NCT04426370</url>
  </required_header>
  <id_info>
    <org_study_id>gd230863</org_study_id>
    <nct_id>NCT04426370</nct_id>
  </id_info>
  <brief_title>The Effects of Social Role Participation on Life Quality</brief_title>
  <official_title>The Effects of Social Role Participation on Life Quality in Rheumatoid Arthritis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Recep Tayyip Erdogan University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Recep Tayyip Erdogan University 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>
      The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the&#xD;
      American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA&#xD;
      patients were compared with 95 healthy volunteer control group. Participants were asked to&#xD;
      complete interview based questionnaires regarding pain, life quality, and social role&#xD;
      participation to obtain additional information during the interview to participate in the&#xD;
      study in 20 min.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the&#xD;
      American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA&#xD;
      patients were compared with 95 healthy volunteer control group. Healthy volunteers were&#xD;
      recruited from the partners next to the patients who came to our outpatient clinic for&#xD;
      examination. The same physician carried out the physical examinations on all participations&#xD;
      and conducted a interview, acquiring information on age, gender, body mass index (BMI),&#xD;
      marriage status, living alone, working, and education. Participants were asked to complete&#xD;
      interview based questionnaires regarding pain, life quality, and social role participation to&#xD;
      obtain additional information during the interview to participate in the study in 20 min.&#xD;
      Examinations took place at the our outpatient clinic. This study did not include all&#xD;
      participants who had accompanying of other rheumatic diseases, musculoskeletal diseases, the&#xD;
      presence of another chronic disease, cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">February 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>4 Months</target_duration>
  <primary_outcome>
    <measure>Social role participation</measure>
    <time_frame>4 months</time_frame>
    <description>Social role participation questionnaire</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">195</enrollment>
  <condition>Social Interaction</condition>
  <arm_group>
    <arm_group_label>Case</arm_group_label>
    <description>100 rheumatoid arthritis patients (age from 20 to 70 years)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>95 healthy volunteer</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>Physical examination and questionnaires</description>
    <arm_group_label>Case</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        100 RA patients and 95 healthy volunteer control&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:The study was carried out among RA patients (age from 20 to 70 years) by&#xD;
        fulfilling the American College of Rheumatology 1987 revised criteria admitted to our&#xD;
        outpatient clinic -&#xD;
&#xD;
        Exclusion Criteria:This study did not include all participants who had accompanying of&#xD;
        other rheumatic diseases, musculoskeletal diseases, the presence of another chronic&#xD;
        disease, cancer.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Recep Tayyip Erdogan University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Gul Devrimsel</investigator_full_name>
    <investigator_title>Assoc. Prof.</investigator_title>
  </responsible_party>
  <!-- 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/NCT04426370
org study id: gd230863
nct id: NCT04426370
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the
      American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA
      patients were compared with 95 healthy volunteer control group. Participants were asked to
      complete interview based questionnaires regarding pain, life quality, and social role
      participation to obtain additional information during the interview to participate in the
      study in 20 min.
The study was carried out among 100 RA patients (age from 20 to 70 years) by fulfilling the
      American College of Rheumatology 1987 revised criteria admitted to our outpatient clinic. RA
      patients were compared with 95 healthy volunteer control group. Healthy volunteers were
      recruited from the partners next to the patients who came to our outpatient clinic for
      examination. The same physician carried out the physical examinations on all participations
      and conducted a interview, acquiring information on age, gender, body mass index (BMI),
      marriage status, living alone, working, and education. Participants were asked to complete
      interview based questionnaires regarding pain, life quality, and social role participation to
      obtain additional information during the interview to participate in the study in 20 min.
      Examinations took place at the our outpatient clinic. This study did not include all
      participants who had accompanying of other rheumatic diseases, musculoskeletal diseases, the
      presence of another chronic disease, cancer.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Social role participation
time frame: 4 months
description: Social role participation questionnaire
arm group label: Case
description: 100 rheumatoid arthritis patients (age from 20 to 70 years)
arm group label: Control
description: 95 healthy volunteer
intervention type: Other
intervention name: Observational
description: Physical examination and questionnaires
arm group label: Case
arm group label: Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
responsible party type: Principal Investigator
investigator affiliation: Recep Tayyip Erdogan University Training and Research Hospital
investigator full name: Gul Devrimsel
investigator title: Assoc. Prof.