<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/NCT03257878</url>
  </required_header>
  <id_info>
    <org_study_id>H-1701-023-821</org_study_id>
    <nct_id>NCT03257878</nct_id>
  </id_info>
  <brief_title>Health-related Quality of Life in Korean Patients With Rheumatic Diseases</brief_title>
  <official_title>Comparative Study Between Systemic Sclerosis and Other Rheumatic Diseases for Health-related Quality of Life in Korean Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      To compare the health related quality of life of patients with systemic sclerosis with other&#xD;
      rheumatic diseases, such as rheumatoid arthritis, systemic lupus erythematosus and Sjogren's&#xD;
      syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Systemic sclerosis (SSc) is a connective tissue disease characterized by vasculopathy,&#xD;
      fibrosis, and autoimmunity. The prognosis of the disease depends on the nature and severity&#xD;
      of organ involvement. Patients with SSc suffer from digital ulceration, arthritis,&#xD;
      progressive skin tightening, and joint contractures that cause pain and limitation of limb&#xD;
      function. The cardiopulmonary system may also be severly affected by SSc in the form of&#xD;
      interstitial lung disease and pulmonary arterial hypertension, which leads to reduction in&#xD;
      exercise capacity and symptomatic dyspnea. Gastrointestinal involvement by SSc may cause&#xD;
      malnutrition, and SSc renal crises may result in renal failure. In addition, cosmetic&#xD;
      disfigurement resulting from facial and limb skin involvement may lead to social isolation,&#xD;
      mood problems, and significant work disability.&#xD;
&#xD;
      It has been reported that health related quality of life (HRQoL) is significantly impared in&#xD;
      SSc patients compared to the general population. Moreover, the degree of impairment in SSc&#xD;
      patients was comparable to those who suffered from other chronic illnesses such as heart and&#xD;
      lung disease, hypertension, diabetes mellitus, and depression. However, there were no studies&#xD;
      yet comparing the HRQoL of SSc patients with other rheumatic diseases, such as rheumatoid&#xD;
      arthritis (RA) and systemic lupus erythematosus (SLE). Especially, information regarding the&#xD;
      impact of SSc on functioning and HRQoL in Korean patients is lacking.&#xD;
&#xD;
      Therefore, the investigators plan to compare the functioning and HRQoL of patients with SSc&#xD;
      with other rheumatic diseases, such as RA, SLE, and Sjogrens's syndrome, and healthy&#xD;
      controls. A validated Korean version of the Medical Outcomes Study Short Form 36 (SF36)&#xD;
      questionnaire and the EuroQol five dimensions questionnaire (EQ-5D) will be used in this&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 31, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>comparison of physical component scores (PCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>comparison of mental component scores (MCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of physical functioning (PF) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of physical role (PR) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of bodily pain (BP) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of general health (GH) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of vitality (VT) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of social functioning (SF) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of emotional role (ER) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of mental health (MH) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>comparison of the scores of the EQ-5D questionnaire between patients with systemic sclerosis and other rheumatic diseases</measure>
    <time_frame>once at inclusion</time_frame>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Scleroderma, Systemic</condition>
  <arm_group>
    <arm_group_label>Systemic sclerosis (SSc)</arm_group_label>
    <description>validated Korean version of the SF36 and EQ-5D</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid arthritis (RA)</arm_group_label>
    <description>validated Korean version of the SF36 and EQ-5D</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Systemic lupus erythematosus (SLE)</arm_group_label>
    <description>validated Korean version of the SF36 and EQ-5D</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sjogren's syndrome</arm_group_label>
    <description>validated Korean version of the SF36 and EQ-5D</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>validated Korean version of the SF36 and EQ-5D</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>validated Korean version of the SF36 and EQ-5D</intervention_name>
    <description>This is an observational prospective study. SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status). The scores of these domains are summarized into the physical component score (PCS) and mental component score (MCS).&#xD;
The EQ-5D questionnaire is made up for 2 components; health state description and evaluation. In description part, health status is measured in terms of 5 dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Rheumatoid arthritis (RA)</arm_group_label>
    <arm_group_label>Sjogren's syndrome</arm_group_label>
    <arm_group_label>Systemic lupus erythematosus (SLE)</arm_group_label>
    <arm_group_label>Systemic sclerosis (SSc)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated at the Rheumatology clinic at Seoul National University Hospital from&#xD;
        March 2017 through to December 2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females &gt; 18 years at time of consent&#xD;
&#xD;
          -  Patients able to understand written and spoken Korean&#xD;
&#xD;
          -  Patients who have been informed about the research&#xD;
&#xD;
          -  Patients with SSc meeting the 1980 ACR criteria or 2013 ACR/EULAR criteria for SSc&#xD;
&#xD;
          -  Patients with RA meeting the 2010 ACR/EULAR criteria&#xD;
&#xD;
          -  Patients with SLE meeting the 1997 ACR criteria or 2012 SLICC criteria&#xD;
&#xD;
          -  Patients with Sjogren's syndrome meeting the 2002 AECG criteria or 2012 ACR criteria&#xD;
&#xD;
          -  Controls : without any rheumatic diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe mental retardation&#xD;
&#xD;
          -  Any impairment of ability to understand making self-evaluation impossible (using a&#xD;
             validated Korean version of the SF36 and EQ-5D)&#xD;
&#xD;
          -  Anyone with other rheumatic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eun Bong Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eun Bong Lee, MD, PhD</last_name>
    <phone>+822-2072-3944</phone>
    <email>leb7616@snu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eun Bong Lee, MD PhD</last_name>
      <phone>82-2-2072-3944</phone>
      <email>leb7616@snu.ac.kr</email>
    </contact>
    <contact_backup>
      <last_name>Jin Kyun Park, MD</last_name>
      <phone>82-2-2072-4765</phone>
      <email>jinkyunpark@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Eun Bong Lee, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Hudson M, Thombs BD, Steele R, Panopalis P, Newton E, Baron M; Canadian Scleroderma Research Group. Quality of life in patients with systemic sclerosis compared to the general population and patients with other chronic conditions. J Rheumatol. 2009 Apr;36(4):768-72. doi: 10.3899/jrheum.080281. Epub 2009 Feb 17.</citation>
    <PMID>19228662</PMID>
  </reference>
  <reference>
    <citation>Georges C, Chassany O, Toledano C, Mouthon L, Tiev K, Meyer O, Ilie D, Rambeloarisoa J, Marjanovic Z, Cabane J, Sereni D, Pouchot J, Farge D. Impact of pain in health related quality of life of patients with systemic sclerosis. Rheumatology (Oxford). 2006 Oct;45(10):1298-302. doi: 10.1093/rheumatology/kel189. Epub 2006 Jun 4.</citation>
    <PMID>16754629</PMID>
  </reference>
  <reference>
    <citation>Del Rosso A, Boldrini M, D'Agostino D, Placidi GP, Scarpato A, Pignone A, Generini S, Konttinen Y, Zoppi M, Vlak T, Placidi G, Matucci-Cerinic M. Health-related quality of life in systemic sclerosis as measured by the Short Form 36: relationship with clinical and biologic markers. Arthritis Rheum. 2004 Jun 15;51(3):475-81. doi: 10.1002/art.20389.</citation>
    <PMID>15188336</PMID>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Eun Bong Lee</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>Rheumatic Diseases</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03257878
org study id: H-1701-023-821
nct id: NCT03257878
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the health related quality of life of patients with systemic sclerosis with other
      rheumatic diseases, such as rheumatoid arthritis, systemic lupus erythematosus and Sjogren's
      syndrome.
Systemic sclerosis (SSc) is a connective tissue disease characterized by vasculopathy,
      fibrosis, and autoimmunity. The prognosis of the disease depends on the nature and severity
      of organ involvement. Patients with SSc suffer from digital ulceration, arthritis,
      progressive skin tightening, and joint contractures that cause pain and limitation of limb
      function. The cardiopulmonary system may also be severly affected by SSc in the form of
      interstitial lung disease and pulmonary arterial hypertension, which leads to reduction in
      exercise capacity and symptomatic dyspnea. Gastrointestinal involvement by SSc may cause
      malnutrition, and SSc renal crises may result in renal failure. In addition, cosmetic
      disfigurement resulting from facial and limb skin involvement may lead to social isolation,
      mood problems, and significant work disability.

      It has been reported that health related quality of life (HRQoL) is significantly impared in
      SSc patients compared to the general population. Moreover, the degree of impairment in SSc
      patients was comparable to those who suffered from other chronic illnesses such as heart and
      lung disease, hypertension, diabetes mellitus, and depression. However, there were no studies
      yet comparing the HRQoL of SSc patients with other rheumatic diseases, such as rheumatoid
      arthritis (RA) and systemic lupus erythematosus (SLE). Especially, information regarding the
      impact of SSc on functioning and HRQoL in Korean patients is lacking.

      Therefore, the investigators plan to compare the functioning and HRQoL of patients with SSc
      with other rheumatic diseases, such as RA, SLE, and Sjogrens's syndrome, and healthy
      controls. A validated Korean version of the Medical Outcomes Study Short Form 36 (SF36)
      questionnaire and the EuroQol five dimensions questionnaire (EQ-5D) will be used in this
      study.
observational model: Other
time perspective: Prospective
measure: comparison of physical component scores (PCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of mental component scores (MCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of physical functioning (PF) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of physical role (PR) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of bodily pain (BP) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of general health (GH) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of vitality (VT) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of social functioning (SF) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of emotional role (ER) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of mental health (MH) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
measure: comparison of the scores of the EQ-5D questionnaire between patients with systemic sclerosis and other rheumatic diseases
time frame: once at inclusion
arm group label: Systemic sclerosis (SSc)
description: validated Korean version of the SF36 and EQ-5D
arm group label: Rheumatoid arthritis (RA)
description: validated Korean version of the SF36 and EQ-5D
arm group label: Systemic lupus erythematosus (SLE)
description: validated Korean version of the SF36 and EQ-5D
arm group label: Sjogren's syndrome
description: validated Korean version of the SF36 and EQ-5D
arm group label: Control
description: validated Korean version of the SF36 and EQ-5D
intervention type: Other
intervention name: validated Korean version of the SF36 and EQ-5D
description: This is an observational prospective study. SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status). The scores of these domains are summarized into the physical component score (PCS) and mental component score (MCS).
The EQ-5D questionnaire is made up for 2 components; health state description and evaluation. In description part, health status is measured in terms of 5 dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS).
arm group label: Control
arm group label: Rheumatoid arthritis (RA)
arm group label: Sjogren's syndrome
arm group label: Systemic lupus erythematosus (SLE)
arm group label: Systemic sclerosis (SSc)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eun Bong Lee, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Eun Bong Lee, MD, PhD
phone: +822-2072-3944
email: leb7616@snu.ac.kr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Korea, Republic of
citation: Hudson M, Thombs BD, Steele R, Panopalis P, Newton E, Baron M; Canadian Scleroderma Research Group. Quality of life in patients with systemic sclerosis compared to the general population and patients with other chronic conditions. J Rheumatol. 2009 Apr;36(4):768-72. doi: 10.3899/jrheum.080281. Epub 2009 Feb 17.
PMID: 19228662
citation: Georges C, Chassany O, Toledano C, Mouthon L, Tiev K, Meyer O, Ilie D, Rambeloarisoa J, Marjanovic Z, Cabane J, Sereni D, Pouchot J, Farge D. Impact of pain in health related quality of life of patients with systemic sclerosis. Rheumatology (Oxford). 2006 Oct;45(10):1298-302. doi: 10.1093/rheumatology/kel189. Epub 2006 Jun 4.
PMID: 16754629
citation: Del Rosso A, Boldrini M, D'Agostino D, Placidi GP, Scarpato A, Pignone A, Generini S, Konttinen Y, Zoppi M, Vlak T, Placidi G, Matucci-Cerinic M. Health-related quality of life in systemic sclerosis as measured by the Short Form 36: relationship with clinical and biologic markers. Arthritis Rheum. 2004 Jun 15;51(3):475-81. doi: 10.1002/art.20389.
PMID: 15188336
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Eun Bong Lee
investigator title: Professor
mesh term: Rheumatic Diseases
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Collagen Diseases
sharing ipd: Undecided