Clinical trial NCT00400868: Effectiveness of Occupational Therapy in Patients With Rheumatoid Arthritis(RCT)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis, occupational therapy, joint protection
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Zürcher Rheumastifung, Zurich, Switzerland
name: Gertrude and Wolfgang Schrader Dislich Foundation
name: Swiss Ligue Against Rheumatism, Zurich, Switzerland
First posted: 2006-11-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: joint protection behavior
timeFrame: before/after intervention, 3,6,12 months follow up
Secondary outcomes:
measure: General quality of life
timeFrame: before intervention, 3,6,12 months follow up
measure: Health related quality of life / physical functional ability
timeFrame: before intervention, 6,12 months follow up
measure: Self-Illness Separation SIS, derived from the PRISM (intervention group)
timeFrame: before/during/after intervention, 3,6,12 months follow up
measure: Goals achievement (intervention group)
timeFrame: during/after intervention, 3,6,12 months follow up
measure: Hand impairment status, including pain
timeFrame: before/during/after intervention, 3,6,12 months follow up
measure: Arthritis self-efficacy and JP-specific self-efficacy
timeFrame: before/after intervention, 3,6,12 months follow up
measure: Self-perceived disease activity
timeFrame: before intervention, 12 months follow up
measure: Clinical data
timeFrame: before intervention, 3, 12 months follow up
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital
city: Valens
country: Switzerland
facility: Rehabilitation Clinic
city: Zurich
country: Switzerland
facility: Schulthess Klinik
city: Zurich
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University of Maastricht NL
name: Robert de Bie, Prof, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital of Zurich, CH
name: Karin Niedermann, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Zurich, CH
name: Stefan Buchi, MD
role: STUDY_DIRECTOR
References: