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

Scleroderma, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03257878
• Other study ID #: H-1701-023-821
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2017
• Last updated: August 18, 2017
• Start date: March 31, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: Eun Bong Lee, MD, PhD
• Phone: +822-2072-3944
• Email: leb7616[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. Epub 2006 Jun 4. — View 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. — View Citation

Outcome

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