Workability in Patients With Seropositive Rheumatoid Arthritis

NCT02581852 | Completed

• 1 other identifier: Workability in RA
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Seropositive Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Workability

  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).

  Day 1

Secondary Outcomes (7)

• Functional Disability

  Day 1

• Frailty

  Day 1

• Lower-extremity function

  Day 1

• Musculus quadriceps femoris strength

  Day1

• Hand grip strength

  Day1

Other Outcomes (3)

• IL-6

  Day1

• TNF-alpha

  Day1

• CRP

  Day 1

Study Arms (1)

Single arm assessment

OTHER

Cross sectional assessment of workability, functional disability, frailty, muscle strength, quality of sleep and sexual functioning of rheumatoid arthritis patients with different disease activity levels.

Other: Cross sectional assessment

Interventions

Cross sectional assessment OTHER

Assessment of workability, functional disability, frailty, muscle strength, quality of sleep and sexual functioning

Single arm assessment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Franz Josef Hospital: lead
• Landsteiner Institut: collaborator

Related Publications (1)

• Berner C, Erlacher L, Quittan M, Fenzl KH, Dorner TE. Workability and Muscle Strength in Patients With Seropositive Rheumatoid Arthritis: Survey Study Protocol. JMIR Res Protoc. 2017 Mar 2;6(3):e36. doi: 10.2196/resprot.6449.

  PMID: 28254736 DERIVED

Study Officials

• Thomas Dorner, Assoc Prof, MD, MPH

  Institute of Social Medicine and Centre of Public Health

  STUDY CHAIR

• Ludwig Erlacher, Prof. MD

  Kaiser Franz Josefs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Ludwig Erlacher

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 6, 2017

Record last verified: 2017-03