NCT00400868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

2.6 years

First QC Date

November 15, 2006

Last Update Submit

February 23, 2010

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, occupational therapy, joint protection

Outcome Measures

Primary Outcomes (1)

  • joint protection behavior

    before/after intervention, 3,6,12 months follow up

Secondary Outcomes (8)

  • General quality of life

    before intervention, 3,6,12 months follow up

  • Health related quality of life / physical functional ability

    before intervention, 6,12 months follow up

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

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

  • Goals achievement (intervention group)

    during/after intervention, 3,6,12 months follow up

  • Hand impairment status, including pain

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

  • +3 more secondary outcomes

Study Arms (1)

standard joint protection education

ACTIVE COMPARATOR

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

Behavioral: psycho-educational Joint protection education

Interventions

psycho-educational Joint protection educationBEHAVIORAL

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

standard joint protection education

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital

Bern, 3010, Switzerland

Location

Rehabilitation Clinic

Valens, 7317, Switzerland

Location

Schulthess Klinik

Zurich, 8008, Switzerland

Location

University Hospital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Robert de Bie, Prof, PhD

    University of Maastricht NL

    STUDY DIRECTOR

  • Karin Niedermann, MPH

    University Hospital of Zurich, CH

    PRINCIPAL INVESTIGATOR

  • Stefan Buchi, MD

    University Hospital of Zurich, CH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 17, 2006

Study Start

July 1, 2006

Primary Completion

February 1, 2009

Study Completion

September 1, 2009

Last Updated

February 24, 2010

Record last verified: 2010-02

Locations

CH(4)