Rheumatoid ArthritisNCT00400868
Effectiveness of Occupational Therapy in Patients With Rheumatoid Arthritis(RCT)
A study testing psycho-educational Joint protection education in people with Rheumatoid Arthritis, run by University of Zurich at 4 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- psycho-educational Joint protection education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesSwitzerland
- Study dates
- Jul 2006to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
University Hospital
Bern, 3010
Rehabilitation Clinic
Valens, 7317
Schulthess Klinik
Zurich, 8008
University Hospital
Zurich, 8091
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- psycho-educational Joint protection education
- Keywords
- rheumatoid arthritis, occupational therapy, joint protection
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psycho-educational Joint protection educationBehavioural
individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later
| Study group | Role | What they receive |
|---|---|---|
| standard joint protection education | Active comparator | psycho-educational joint protection vs. usual care (standard joint protection education) Receives: Behavioral: psycho-educational Joint protection education |
What is being measured
The primary outcome is the main question the study is designed to answer.
joint protection behavior
Measured: before/after intervention, 3,6,12 months follow up
Secondary outcomes (8)
General quality of life
Measured: before intervention, 3,6,12 months follow up
Health related quality of life / physical functional ability
Measured: before intervention, 6,12 months follow up
Self-Illness Separation SIS, derived from the PRISM (intervention group)
Measured: before/during/after intervention, 3,6,12 months follow up
Goals achievement (intervention group)
Measured: during/after intervention, 3,6,12 months follow up
Hand impairment status, including pain
Measured: before/during/after intervention, 3,6,12 months follow up
Arthritis self-efficacy and JP-specific self-efficacy
Measured: before/after intervention, 3,6,12 months follow up
Self-perceived disease activity
Measured: before intervention, 12 months follow up
Clinical data
Measured: before intervention, 3, 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Zürcher Rheumastifung, Zurich, Switzerland, Gertrude and Wolfgang Schrader Dislich Foundation, Swiss Ligue Against Rheumatism, Zurich, Switzerland
- Investigators
- Robert de Bie, Prof, PhD, Study director, University of Maastricht NLKarin Niedermann, MPH, Principal investigator, University Hospital of Zurich, CHStefan Buchi, MD, Study director, University Hospital of Zurich, CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400868
- Sponsor's protocol ID
- niedk_EK444_
- Status last verified
- Feb 2010
- First submitted
- 15 Nov 2006
- Last updated
- 24 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00400868
- Acronym / sponsor ID
- niedk_EK444_
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, occupational therapy, joint protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Zürcher Rheumastifung, Zurich, Switzerland, Gertrude and Wolfgang Schrader Dislich Foundation, Swiss Ligue Against Rheumatism, Zurich, Switzerland
- Study start
- Jul 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| standard joint protection education | Active comparator | Behavioral: psycho-educational Joint protection educationpsycho-educational joint protection vs. usual care (standard joint protection education) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psycho-educational Joint protection educationindividualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later | Behavioural | standard joint protection education |
Primary outcome
joint protection behavior
Time frame: before/after intervention, 3,6,12 months follow up
8 secondary outcomes
General quality of life
Time frame: before intervention, 3,6,12 months follow up
Health related quality of life / physical functional ability
Time frame: before intervention, 6,12 months follow up
Self-Illness Separation SIS, derived from the PRISM (intervention group)
Time frame: before/during/after intervention, 3,6,12 months follow up
Goals achievement (intervention group)
Time frame: during/after intervention, 3,6,12 months follow up
Hand impairment status, including pain
Time frame: before/during/after intervention, 3,6,12 months follow up
Arthritis self-efficacy and JP-specific self-efficacy
Time frame: before/after intervention, 3,6,12 months follow up
Self-perceived disease activity
Time frame: before intervention, 12 months follow up
Clinical data
Time frame: before intervention, 3, 12 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert de Bie, Prof, PhD study director
University of Maastricht NL
Karin Niedermann, MPH principal investigator
University Hospital of Zurich, CH
Stefan Buchi, MD study director
University Hospital of Zurich, CH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psycho-educational Joint protection education in people with Rheumatoid Arthritis, run by University of Zurich at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
joint protection behavior (time frame: before/after intervention, 3,6,12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2010.