Effectiveness of Occupational Therapy in Patients With Rheumatoid Arthritis(RCT)

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: psycho-educational Joint protection education

• Registration Number: NCT00400868
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-17
• Primary Completion: 2009-02
• Study Completion: 2009-09
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-23
• Last Update Posted: 2010-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard joint protection education	psycho-educational Joint protection education	psycho-educational joint protection vs. usual care (standard joint protection education)

Primary Outcome Measures

Name	Time	Method
joint protection behavior	before/after intervention, 3,6,12 months follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University Hospital; 🇨🇭 Zurich, Switzerland

Schulthess Klinik; 🇨🇭 Zurich, Switzerland

Rehabilitation Clinic; 🇨🇭 Valens, Switzerland