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Clinical Trials/NCT00400868
NCT00400868
Completed
N/A

A Randomized Controlled Study to Evaluate the Short- and Long-term Effectiveness of an Individualized Resource Oriented Occupational Therapy for Patients With Rheumatoid Arthritis

University of Zurich3 sites in 1 country54 target enrollmentJuly 2006

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
University of Zurich
Enrollment
54
Locations
3
Primary Endpoint
joint protection behavior
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of the study is to compare the short- and long-term effectiveness of an individualized, resource-oriented joint protection intervention with the standard, problem-oriented joint protection intervention for patients with rheumatoid arthritis.

Detailed Description

Joint Protection (JP)is an important intervention in the management of people with arthritis. Altering working methods (e.g. use of proximal joints, dynamic activities), energy conservation (balance between activity and rest) and using assistive devices should place less strain on joint structures weakened by the disease process. These strategies ought to decrease pain and stress on joints, improve function, and facilitate maintaining social roles. The effectiveness of JP has been evaluated in a number of studies, all in a group setting. JP has beneficial short-term effects on pain and function in patients with established RA and moderate functional problems. Using assistive devices reduces pain during task performance in comparison to normal methods and altering working methods significantly reduces difficulties in activities of daily living (ADL). However this generally does not result in significant behavioral changes and a long-term impact on reducing pain and maintaining function may only be reached if JP is taught using behavioral education methods. Additionally, adherence of RA patients to different interventions is generally modest, which may well determine the effectiveness of any given intervention, especially in the long-term. All previous studies were carried out in group settings, however, in Switzerland, standard JP education is provided on a one-to-one basis and an individualized education is assumed to be a promising approach. This clinical trial aims to test the hypothesis that an individualized, resource-oriented JP education in RA patients leads to a better therapy success in the short and long-term, compared to problem-oriented standard JP education in terms of joint protection behavior. Secondary outcome parameters are self-perception, general and specific self-efficacy and general and health-related quality of life.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
September 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of RA according to ACR Guidelines (1988)
  • Actual hand pain on activity or history of wrist and/or metacarpophalangeal(MCP) joint pain and inflammation
  • Referred to OT for a Joint Protection intervention program
  • Willingness to comply with the randomly assigned treatment and informed consent
  • Functional Class: 2 to 4
  • German speaking/understanding/reading
  • Sufficient cognitive capacities to understand the aims and procedures of the proposed study and the requirements of participation

Exclusion Criteria

  • Functional class 1 (anticipated self-exclusion, as patients in class 1 will not be referred to JP).
  • Severe finger, hand, elbow or shoulder deformities
  • Insufficient ability to understand, speak and read the German language
  • Insufficient cognitive capacities to understand the aims and procedures of the proposed study and the requirements of participation.

Outcomes

Primary Outcomes

joint protection behavior

Time Frame: before/after intervention, 3,6,12 months follow up

Secondary Outcomes

  • Health related quality of life / physical functional ability(before intervention, 6,12 months follow up)
  • Self-Illness Separation SIS, derived from the PRISM (intervention group)(before/during/after intervention, 3,6,12 months follow up)
  • General quality of life(before intervention, 3,6,12 months follow up)
  • Goals achievement (intervention group)(during/after intervention, 3,6,12 months follow up)
  • Hand impairment status, including pain(before/during/after intervention, 3,6,12 months follow up)
  • Arthritis self-efficacy and JP-specific self-efficacy(before/after intervention, 3,6,12 months follow up)
  • Self-perceived disease activity(before intervention, 12 months follow up)
  • Clinical data(before intervention, 3, 12 months follow up)

Study Sites (3)

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