Workability in Patients With Seropositive Rheumatoid Arthritis
Condition: Seropositive Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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%.
    

Intervention name(s): Cross sectional assessment
Intervention type(s): Other
Intervention description(s): Assessment of workability, functional disability, frailty, muscle strength, quality of sleep and sexual functioning
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care