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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: psycho-educational Joint protection education

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital
  • Valens, Switzerland, 7317
    • Rehabilitation Clinic
  • Zurich, Switzerland, 8008
    • Schulthess Klinik
  • Zurich, Switzerland, 8091
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard joint protection education; psycho-educational joint protection vs. usual care (standard joint protection education)	Behavioral: psycho-educational Joint protection education; individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
joint protection behavior	before/after intervention, 3,6,12 months follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
General quality of life	before intervention, 3,6,12 months follow up
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
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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Zürcher Rheumastifung, Zurich, Switzerland; Gertrude and Wolfgang Schrader Dislich Foundation; Swiss Ligue Against Rheumatism, Zurich, Switzerland
• Investigators: Study Director: Robert de Bie, Prof, PhD, University of Maastricht NL; Principal Investigator: Karin Niedermann, MPH, University Hospital of Zurich, CH; Study Director: Stefan Buchi, MD, University Hospital of Zurich, CH

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: November 15, 2006
• First Submitted That Met QC Criteria: November 15, 2006
• First Posted (Estimate): November 17, 2006

Study Record Updates

• Last Update Posted (Estimate): February 24, 2010
• Last Update Submitted That Met QC Criteria: February 23, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: rheumatoid arthritis, occupational therapy, joint protection
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: niedk_EK444_