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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400868
• Other study ID #: niedk_EK444_
• Status: Completed
• Phase: N/A
• First received: November 15, 2006
• Last updated: February 23, 2010
• Start date: July 2006
• Est. completion date: September 2009

Study information

• Verified date: February 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital	Bern
Switzerland	Rehabilitation Clinic	Valens
Switzerland	Schulthess Klinik	Zurich
Switzerland	University Hospital	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Gertrude und Wolfgang Schrader-Dislich Stiftung, Zurich, Switzerland, Swiss Ligue Against Rheumatism, Zurich, Switzerland, Zürcher Rheumastifung , Zurich, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	joint protection behavior		before/after intervention, 3,6,12 months follow up	No
Secondary	General quality of life		before intervention, 3,6,12 months follow up	No
Secondary	Health related quality of life / physical functional ability		before intervention, 6,12 months follow up	No
Secondary	Self-Illness Separation SIS, derived from the PRISM (intervention group)		before/during/after intervention, 3,6,12 months follow up	No
Secondary	Goals achievement (intervention group)		during/after intervention, 3,6,12 months follow up	No
Secondary	Hand impairment status, including pain		before/during/after intervention, 3,6,12 months follow up	No
Secondary	Arthritis self-efficacy and JP-specific self-efficacy		before/after intervention, 3,6,12 months follow up	No
Secondary	Self-perceived disease activity		before intervention, 12 months follow up	No
Secondary	Clinical data		before intervention, 3, 12 months follow up	No