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Health-related Quality of Life in Korean Patients With Rheumatic Diseases

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ClinicalTrials.gov Identifier: NCT03257878
Recruitment Status : Unknown
Verified April 2017 by Eun Bong Lee, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Eun Bong Lee, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Scleroderma, Systemic Other: validated Korean version of the SF36 and EQ-5D

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparative Study Between Systemic Sclerosis and Other Rheumatic Diseases for Health-related Quality of Life in Korean Patients
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Group/Cohort Intervention/treatment
Systemic sclerosis (SSc)
validated Korean version of the SF36 and EQ-5D
Other: validated Korean version of the SF36 and EQ-5D

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).


Rheumatoid arthritis (RA)
validated Korean version of the SF36 and EQ-5D
Other: validated Korean version of the SF36 and EQ-5D

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).


Systemic lupus erythematosus (SLE)
validated Korean version of the SF36 and EQ-5D
Other: validated Korean version of the SF36 and EQ-5D

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).


Sjogren's syndrome
validated Korean version of the SF36 and EQ-5D
Other: validated Korean version of the SF36 and EQ-5D

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).


Control
validated Korean version of the SF36 and EQ-5D
Other: validated Korean version of the SF36 and EQ-5D

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).





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. comparison of vitality (VT) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases [ Time Frame: once at inclusion ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. comparison of the scores of the EQ-5D questionnaire between patients with systemic sclerosis and other rheumatic diseases [ Time Frame: once at inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients treated at the Rheumatology clinic at Seoul National University Hospital from March 2017 through to December 2017
Criteria

Inclusion Criteria:

  • Males or females > 18 years at time of consent
  • Patients able to understand written and spoken Korean
  • Patients who have been informed about the research
  • Patients with SSc meeting the 1980 ACR criteria or 2013 ACR/EULAR criteria for SSc
  • Patients with RA meeting the 2010 ACR/EULAR criteria
  • Patients with SLE meeting the 1997 ACR criteria or 2012 SLICC criteria
  • Patients with Sjogren's syndrome meeting the 2002 AECG criteria or 2012 ACR criteria
  • Controls : without any rheumatic diseases

Exclusion Criteria:

  • Severe mental retardation
  • Any impairment of ability to understand making self-evaluation impossible (using a validated Korean version of the SF36 and EQ-5D)
  • Anyone with other rheumatic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257878


Contacts
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Contact: Eun Bong Lee, MD, PhD +822-2072-3944 leb7616@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Eun Bong Lee, MD PhD    82-2-2072-3944    leb7616@snu.ac.kr   
Contact: Jin Kyun Park, MD    82-2-2072-4765    jinkyunpark@gmail.com   
Principal Investigator: Eun Bong Lee, MD PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Eun Bong Lee, MD, PhD Seoul National University Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eun Bong Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03257878     History of Changes
Other Study ID Numbers: H-1701-023-821
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Musculoskeletal Diseases
Connective Tissue Diseases
Skin Diseases