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

NCT ID: NCT00400868

Last Updated: 2010-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-09-30

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

standard joint protection education

psycho-educational joint protection vs. usual care (standard joint protection education)

Group Type: ACTIVE_COMPARATOR

psycho-educational Joint protection education

Intervention Type: BEHAVIORAL

individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later

Interventions

psycho-educational Joint protection education

individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zürcher Rheumastifung, Zurich, Switzerland

OTHER

Sponsor Role: collaborator

Gertrude and Wolfgang Schrader Dislich Foundation

OTHER

Sponsor Role: collaborator

Swiss Ligue Against Rheumatism, Zurich, Switzerland

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Zurich

Principal Investigators

Robert de Bie, Prof, PhD

Role: STUDY_DIRECTOR

University of Maastricht NL

Karin Niedermann, MPH

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Zurich, CH

Stefan Buchi, MD

Role: STUDY_DIRECTOR

University Hospital of Zurich, CH

Locations

University Hospital

Bern, , Switzerland

Rehabilitation Clinic

Valens, , Switzerland

Schulthess Klinik

Zurich, , Switzerland

University Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

niedk_EK444_

Identifier Type: -

Identifier Source: org_study_id