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

This study has been completed.
Sponsor:
Collaborators:
Zürcher Rheumastifung , Zurich, Switzerland
Gertrude und Wolfgang Schrader-Dislich Stiftung, Zurich, Switzerland
Swiss Ligue Against Rheumatism, Zurich, Switzerland
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00400868
First received: November 15, 2006
Last updated: February 23, 2010
Last verified: February 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • joint protection behavior [ Time Frame: before/after intervention, 3,6,12 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400868

Locations
Switzerland
University Hospital
Bern, Switzerland, 3010
Rehabilitation Clinic
Valens, Switzerland, 7317
Schulthess Klinik
Zurich, Switzerland, 8008
University Hospital
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Zürcher Rheumastifung , Zurich, Switzerland
Gertrude und Wolfgang Schrader-Dislich Stiftung, Zurich, Switzerland
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
  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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014