Effectiveness of Occupational Therapy in Patients With Rheumatoid Arthritis(RCT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis |
Behavioral: psycho-educational Joint protection education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- joint protection behavior [ Time Frame: before/after intervention, 3,6,12 months follow up ] [ Designated as safety issue: No ]
- General quality of life [ Time Frame: before intervention, 3,6,12 months follow up ] [ Designated as safety issue: No ]
- Health related quality of life / physical functional ability [ Time Frame: before intervention, 6,12 months follow up ] [ Designated as safety issue: No ]
- Self-Illness Separation SIS, derived from the PRISM (intervention group) [ Time Frame: before/during/after intervention, 3,6,12 months follow up ] [ Designated as safety issue: No ]
- Goals achievement (intervention group) [ Time Frame: during/after intervention, 3,6,12 months follow up ] [ Designated as safety issue: No ]
- Hand impairment status, including pain [ Time Frame: before/during/after intervention, 3,6,12 months follow up ] [ Designated as safety issue: No ]
- Arthritis self-efficacy and JP-specific self-efficacy [ Time Frame: before/after intervention, 3,6,12 months follow up ] [ Designated as safety issue: No ]
- Self-perceived disease activity [ Time Frame: before intervention, 12 months follow up ] [ Designated as safety issue: No ]
- Clinical data [ Time Frame: before intervention, 3, 12 months follow up ] [ Designated as safety issue: No ]
| Enrollment: | 54 |
| Study Start Date: | July 2006 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Switzerland | |
| University Hospital | |
| Bern, Switzerland, 3010 | |
| Rehabilitation Clinic | |
| Valens, Switzerland, 7317 | |
| University Hospital | |
| Zurich, Switzerland, 8091 | |
| Schulthess Klinik | |
| Zurich, Switzerland, 8008 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Karin Niedermann, MPH, University Hospital Zurich |
| ClinicalTrials.gov Identifier: | NCT00400868 History of Changes |
| Other Study ID Numbers: | niedk_EK444_ |
| Study First Received: | November 15, 2006 |
| Last Updated: | February 23, 2010 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University of Zurich:
|
rheumatoid arthritis, occupational therapy, joint protection |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013