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Completed

NCT Number: NCT00400868

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Bern, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

psycho-educational Joint protection education

Behavioral

individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later

Primary outcomes

  1. joint protection behavior

    Time frame: before/after intervention, 3,6,12 months follow up

Secondary outcomes

  1. General quality of life

    Time frame: before intervention, 3,6,12 months follow up

  2. Health related quality of life / physical functional ability

    Time frame: before intervention, 6,12 months follow up

  3. Self-Illness Separation SIS, derived from the PRISM (intervention group)

    Time frame: before/during/after intervention, 3,6,12 months follow up

  4. Goals achievement (intervention group)

    Time frame: during/after intervention, 3,6,12 months follow up

  5. Hand impairment status, including pain

    Time frame: before/during/after intervention, 3,6,12 months follow up

  6. Arthritis self-efficacy and JP-specific self-efficacy

    Time frame: before/after intervention, 3,6,12 months follow up

  7. Self-perceived disease activity

    Time frame: before intervention, 12 months follow up

  8. Clinical data

    Time frame: before intervention, 3, 12 months follow up

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Gertrude and Wolfgang Schrader Dislich Foundation
  • Swiss Ligue Against Rheumatism, Zurich, Switzerland
  • Zürcher Rheumastifung, Zurich, Switzerland

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 17, 2006
Registry last updated
Feb 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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