<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/NCT02968745</url>
  </required_header>
  <id_info>
    <org_study_id>UFMG ETIC 024/09</org_study_id>
    <nct_id>NCT02968745</nct_id>
  </id_info>
  <brief_title>Occupational Performance Problems in Individuals With Rheumatoid Arthritis</brief_title>
  <official_title>Occupational Performance Problems Frequently Reported by Individuals With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Minas Gerais</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To identify the main occupational performance problems reported by individuals with&#xD;
      rheumatoid arthritis and the relationship between these activities with work status of&#xD;
      participants . Methods: the investigators conducted a cross-sectional study with 81 patients&#xD;
      with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was&#xD;
      described in frequencies and percentages, and the Pearson's chi-square test was used to&#xD;
      determine the asymptotic association between the occupational performance problems with work.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For this cross-sectional study, 81 patients were recruited by convenience at the Clinical&#xD;
      Hospital (HC) of the Universidade Federal de Minas Gerais (UFMG), in Brazil.&#xD;
&#xD;
      COPM was applied to identify the main occupational performance problems reported by&#xD;
      participants. The COPM is an individual measure of self-awareness about the problems faced&#xD;
      when carrying out the activities. It identifies problems in the areas of self-care,&#xD;
      productivity, and leisure, and measure the individual's performance and satisfaction&#xD;
      regarding these activities&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_date>
  <completion_date type="Actual">August 2010</completion_date>
  <primary_completion_date type="Actual">August 2009</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Canadian Occupational Performance Measure</measure>
    <time_frame>June 2009 to August 2010</time_frame>
    <description>The COPM protocol is divided into three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10 (a score of one indicated no importance and a score of 10 indicated extreme importance),</description>
  </primary_outcome>
  <enrollment type="Actual">81</enrollment>
  <condition>RheumatoId Arthritis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational study</intervention_name>
    <description>Canadian Occupational Performance Measure (COPM) was applied to identify the main occupational performance problems</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        For this cross-sectional study, 81 patients treated between 2009 and August 2010 in&#xD;
        clinical Hospital, at the Universidade Federal de Minas Gerais (UFMG) in Brazil werw&#xD;
        recruited by convenience sampling&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 46 years old;&#xD;
&#xD;
          -  diagnosed with RA by rheumatologist (American College of Rheumatology);&#xD;
&#xD;
          -  mental competency as assessed with the Mental State Mini-Examination;&#xD;
&#xD;
          -  possessed the skills to understand the instructions study.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  had undergone surgery in the upper limbs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>46 Years</minimum_age>
    <maximum_age>61 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>Júnia Amorim Andrade</investigator_full_name>
    <investigator_title>PHD Júnia Amorim Andrade</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>human activity</keyword>
  <keyword>Canadian Occupational Performance Measure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not plan to Share IPD</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/NCT02968745
org study id: UFMG ETIC 024/09
nct id: NCT02968745
lead sponsor: 
has dmc: No
Aim: To identify the main occupational performance problems reported by individuals with
      rheumatoid arthritis and the relationship between these activities with work status of
      participants . Methods: the investigators conducted a cross-sectional study with 81 patients
      with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was
      described in frequencies and percentages, and the Pearson's chi-square test was used to
      determine the asymptotic association between the occupational performance problems with work.
For this cross-sectional study, 81 patients were recruited by convenience at the Clinical
      Hospital (HC) of the Universidade Federal de Minas Gerais (UFMG), in Brazil.

      COPM was applied to identify the main occupational performance problems reported by
      participants. The COPM is an individual measure of self-awareness about the problems faced
      when carrying out the activities. It identifies problems in the areas of self-care,
      productivity, and leisure, and measure the individual's performance and satisfaction
      regarding these activities
time perspective: Cross-Sectional
measure: Canadian Occupational Performance Measure
time frame: June 2009 to August 2010
description: The COPM protocol is divided into three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10 (a score of one indicated no importance and a score of 10 indicated extreme importance),
intervention type: Other
intervention name: Observational study
description: Canadian Occupational Performance Measure (COPM) was applied to identify the main occupational performance problems
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 46 Years
maximum age: 61 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: Júnia Amorim Andrade
investigator title: PHD Júnia Amorim Andrade
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No
ipd description: Not plan to Share IPD