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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
psycho-educational Joint protection education
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, occupational therapy, joint protection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital
  • Rehabilitation Clinic
  • Schulthess Klinik
  • University Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

standard joint protection education

Arm Description

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

Outcomes

Primary Outcome Measures

joint protection behavior

Secondary Outcome Measures

General quality of life
Health related quality of life / physical functional ability
Self-Illness Separation SIS, derived from the PRISM (intervention group)
Goals achievement (intervention group)
Hand impairment status, including pain
Arthritis self-efficacy and JP-specific self-efficacy
Self-perceived disease activity
Clinical data

Full Information

First Posted
November 15, 2006
Last Updated
February 23, 2010
Sponsor
University of Zurich
Collaborators
Zürcher Rheumastifung, Zurich, Switzerland, Gertrude and Wolfgang Schrader Dislich Foundation, Swiss Ligue Against Rheumatism, Zurich, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT00400868
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich
Collaborators
Zürcher Rheumastifung, Zurich, Switzerland, Gertrude and Wolfgang Schrader Dislich Foundation, Swiss Ligue Against Rheumatism, Zurich, Switzerland

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, occupational therapy, joint protection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard joint protection education
Arm Type
Active Comparator
Arm Description
psycho-educational joint protection vs. usual care (standard joint protection education)
Intervention Type
Behavioral
Intervention Name(s)
psycho-educational Joint protection education
Intervention Description
individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later
Primary Outcome Measure Information:
Title
joint protection behavior
Time Frame
before/after intervention, 3,6,12 months follow up
Secondary Outcome Measure Information:
Title
General quality of life
Time Frame
before intervention, 3,6,12 months follow up
Title
Health related quality of life / physical functional ability
Time Frame
before intervention, 6,12 months follow up
Title
Self-Illness Separation SIS, derived from the PRISM (intervention group)
Time Frame
before/during/after intervention, 3,6,12 months follow up
Title
Goals achievement (intervention group)
Time Frame
during/after intervention, 3,6,12 months follow up
Title
Hand impairment status, including pain
Time Frame
before/during/after intervention, 3,6,12 months follow up
Title
Arthritis self-efficacy and JP-specific self-efficacy
Time Frame
before/after intervention, 3,6,12 months follow up
Title
Self-perceived disease activity
Time Frame
before intervention, 12 months follow up
Title
Clinical data
Time Frame
before intervention, 3, 12 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert de Bie, Prof, PhD
Organizational Affiliation
University of Maastricht NL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karin Niedermann, MPH
Organizational Affiliation
University Hospital of Zurich, CH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Buchi, MD
Organizational Affiliation
University Hospital of Zurich, CH
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Rehabilitation Clinic
City
Valens
ZIP/Postal Code
7317
Country
Switzerland
Facility Name
Schulthess Klinik
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Facility Name
University Hospital
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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

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