跳至主要内容
临床试验/NCT03257878
NCT03257878Unknown不适用

Comparative Study Between Systemic Sclerosis and Other Rheumatic Diseases for Health-related Quality of Life in Korean Patients

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年3月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
comparison of physical component scores (PCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

comparison of physical component scores (PCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases

时间窗: once at inclusion

次要结局

  • comparison of physical functioning (PF) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)
  • comparison of physical role (PR) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)
  • comparison of bodily pain (BP) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)
  • comparison of general health (GH) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)
  • comparison of mental health (MH) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)
  • comparison of the scores of the EQ-5D questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)
  • comparison of mental component scores (MCS) of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)
  • comparison of vitality (VT) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)
  • comparison of social functioning (SF) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)
  • comparison of emotional role (ER) scores of the SF 36 questionnaire between patients with systemic sclerosis and other rheumatic diseases(once at inclusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eun Bong Lee

Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验

Health-related Quality of Life in Korean Patients... | 临床试验