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临床试验/NCT02581852
NCT02581852已完成不适用

Workability in Patients With Seropositive Rheumatoid Arthritis

Kaiser Franz Josef Hospital0 个研究点目标入组 100 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
主要终点
Workability

研究概览

简要总结

This study compares workability in subjects with seropositive rheumatoid arthritis (RA) in the working age with high and low disease activity. Further interest is to clarify the influence of frailty, functional ability and muscle strength on workability and to determine the effect of disease activity on selected physiological needs (sleep quality, sexual functioning). Methods include a physical examination, questionnaires and physical tests.

详细描述

Chronic diseases like RA are negatively associated with workability and RA has been shown to be an economic burden for society and patients. RA patients seem also to be more prone to frailty which is characterized by slowed walking speed, low physical activity, and low grip strength. Also poor sleep has been shown to negatively influence work ability and the majority of patients with RA experience insomnia, general fatigue and mental fatigue. RA has also been shown affect sexual functioning.

This monocentric cross sectional study will be conducted at a Viennese rheumatological outpatient clinic and day hospital on about 100 seropositive RA patients. The primary objective of this study is to compare workability in subjects with seropositive RA in the working age with high and low disease activity. Secondary interest is to clarify the influence of frailty, functional ability and muscle strength on workability and to determine the effect of disease activity on selected physiological needs (sleep quality, sexual functioning). Disease activity will be assessed during the patient's routine visit at the clinic via the clinical disease activity index (CDAI). Workability will be determined by the Work Ability Index questionnaire. The influencing determinants frailty and functional disability will be also assessed via questionnaires and/or with physical examinations (Survey of Health, Ageing and Retirement in Europe Frailty instrument, Short Physical Performance Battery, Health Assessment Questionnaire-Disability Index). For muscle strength assessment hand grip and maximum quadriceps strength will be measured . Contributing physiologic needs quality sleep and sexual functioning will be additionally determined vial self reported questionnaire (Medical Outcome Study -Sleep Scale, Index for sexual functioning).

In order to compare patients with low and high disease activity regarding metric data (like sleep quality or sexual functioning) unpaired Students t-tests (given normal distributed data and homogeneous variances), Welch corrected unpaired Student t-tests (in case of normal distributed data but heterogenous variances) or Mann-Whitney-U tests (in case of skewed data) will be used. Kolmogorov-Smirnov and Levene tests will be used to test for normal distribution and homogenous variances.To assess the impact of frailty, functional ability, muscle strength on workability (high versus low) binary logistic regression will be applied. In general the alpha level is set to 5%.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Seropositive rheumatoid arthritis according to EULAR Criteria
  • Age ≥18 and ≤65 years

排除标准

  • Cannot understand questionnaires in the languages provided (German , English, Turkish, Serb o-Croatian)
  • Cannot understand instructions for physical tests/assessments.

结局指标

主要结局

Workability

时间窗: Day 1

Self-reported work ability will be measured by the work ability index (WAI). The WAI is a questionnaire consisting of seven subscales: current work ability compared with the lifetime best; work ability in relation to the demands of the job; number of current diseases diagnosed by a physician; estimated work impairment due to disease; sick leave during the past 12 month; own prognosis of work ability 2 years from now; and mental resources. The cumulative index of WAI ranges from 7 to 49 points. It is then divided into 4 categories: poor (7-27 points), moderate (28-36 points), good (37-43 points) and excellent work ability (44-49 points).

次要结局

  • Frailty(Day 1)
  • Lower-extremity function(Day 1)
  • Quality of sleep(Day1)
  • Musculus quadriceps femoris strength(Day1)
  • Hand grip strength(Day1)
  • Functional Disability(Day 1)
  • Sexual functioning(Day1)

研究者

发起方
Kaiser Franz Josef Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolin Berner

Prof. Dr. Ludwig Erlacher

Kaiser Franz Josef Hospital

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