Rheumatoid ArthritisRAEUSNCT02351401
Rheumatoid Arthritis Through Education and US Study (RAEUS)
A study testing Education using ultrasonography as feedback tool in people with Rheumatoid Arthritis, run by National University Hospital, Singapore.
Trial summary
Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint swelling is poor. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Education using ultrasonography as feedback tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Oct 2013
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA patients fulfilling ACR1987 criteria
- adults between age 21 and 80 years
Who cannot join
- pregnant
- no mental health illness
- fit to perform informed consent
About this study
Official title: Improvement in Patient Awareness and Ability to Assess Disease in Rheumatoid Arthritis: Rheumatoid Arthritis Through Education and US Study (RAEUS)
Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint swelling is poor. The objective is to evaluate the use of education by ultrasound feedback on the ability of patients to assess for clinical synovitis swollen joints in RA.
Read the detailed description
Design: 6-month single centre randomized controlled trial. Patients: established RA. Intervention: education on self-assessment of joints that included initial brief patient training on tender (TJC) and swollen (SJC) joint counts, followed by US feedback every 3 months versus standard care without education. Patient and physician independently performed 28-joint counts at each visit. Outcome variables: (Primary) Percentage of patients with good agreement with physician derived swollen joints (prevalence-adjusted bias adjusted kappa, PABAK>0.6). Other variables: Agreement in SJC (Bland and Altman 95% limits of agreement), feasibility/patient satisfaction survey and disease activity score (DAS28) at 6 months.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Education using ultrasonography as feedback tool
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education using ultrasonography as feedback toolBehavioural
Education using ultrasonography as feedback tool
| Study group | Role | What they receive |
|---|---|---|
| Education with ultrasonography | Experimental | Intervention includes education of self-assessment of synovitis using ultrasonography as a feedback training tool Receives: Behavioral: Education using ultrasonography as feedback tool |
| Standard Care | No intervention | Normal standard care where patients are not taught how to self-assess for synovitis, without ultrasonography a training tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence-adjusted bias adjusted kappa, PABAK>0.6
Measured: at 6 months
Secondary outcomes (3)
Bland and Altman 95% limits of agreement
swollen joint count agreement
Measured: 6 months
Level of satisfaction
Likert response, satisfaction survey
Measured: 6 months
disease activity score in 28 joints (DAS28)
composite score that measures disease activity incorporating tender joint count, swollen joint count, erythrocyte sedimentation rate and patient global assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
- Investigators
- Peter Cheung, Principal investigator, National University Hospital, Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351401
- Sponsor's protocol ID
- 2011/01611
- Acronym
- RAEUS
- Status last verified
- Jan 2015
- First submitted
- 12 Jan 2015
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheung PP, Lahiri M, Teng GG, Lim AY, Lau TC, Lateef A, Mak A, Gossec L, March L. A randomized controlled trial for improving patient self-assessment of synovitis in rheumatoid arthritis with education by ultrasonography: the RAEUS Study. Rheumatology (Oxford). 2015 Jul;54(7):1161-9. doi: 10.1093/rheumatology/keu447. Epub 2014 Dec 3.
PubMed 25477057
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Patient Awareness and Ability to Assess Disease in Rheumatoid Arthritis: Rheumatoid Arthritis Through Education and US Study (RAEUS)
- ClinicalTrials.gov ID
- NCT02351401
- Acronym / sponsor ID
- RAEUS / 2011/01611
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Jan 2015 (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.
Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint swelling is poor. The objective is to evaluate the use of education by ultrasound feedback on the ability of patients to assess for clinical synovitis swollen joints in RA.
Detailed description
Design: 6-month single centre randomized controlled trial. Patients: established RA. Intervention: education on self-assessment of joints that included initial brief patient training on tender (TJC) and swollen (SJC) joint counts, followed by US feedback every 3 months versus standard care without education. Patient and physician independently performed 28-joint counts at each visit. Outcome variables: (Primary) Percentage of patients with good agreement with physician derived swollen joints (prevalence-adjusted bias adjusted kappa, PABAK>0.6). Other variables: Agreement in SJC (Bland and Altman 95% limits of agreement), feasibility/patient satisfaction survey and disease activity score (DAS28) at 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education with ultrasonography | Experimental | Behavioral: Education using ultrasonography as feedback toolIntervention includes education of self-assessment of synovitis using ultrasonography as a feedback training tool |
| Standard Care | No intervention | –Normal standard care where patients are not taught how to self-assess for synovitis, without ultrasonography a training tool |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- RA patients fulfilling ACR1987 criteria
- adults between age 21 and 80 years
Key exclusion criteria (3 listed)
- pregnant
- no mental health illness
- fit to perform informed consent
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 |
|---|---|---|
| Education using ultrasonography as feedback toolEducation using ultrasonography as feedback tool | Behavioural | Education with ultrasonography |
Primary outcome
prevalence-adjusted bias adjusted kappa, PABAK>0.6
Time frame: at 6 months
3 secondary outcomes
Bland and Altman 95% limits of agreement
Time frame: 6 months
Level of satisfaction
Time frame: 6 months
disease activity score in 28 joints (DAS28)
Time frame: 6 months
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 30 Jan 2015.
- Derived from this study: PubMed 25477057Cheung PP, Lahiri M, Teng GG, Lim AY, Lau TC, Lateef A, Mak A, Gossec L, March L. A randomized controlled trial for improving patient self-assessment of synovitis in rheumatoid arthritis with education by ultrasonography: the RAEUS Study. Rheumatology (Oxford). 2015 Jul;54(7):1161-9. doi: 10.1093/rheumatology/keu447. Epub 2014 Dec 3.
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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.
Peter Cheung principal investigator
National University Hospital, Rheumatology
Questions about this trial
What is this clinical trial studying?
A study testing Education using ultrasonography as feedback tool in people with Rheumatoid Arthritis, run by National University Hospital, Singapore.
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 2 inclusion and 3 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 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
prevalence-adjusted bias adjusted kappa, PABAK>0.6 (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351401, which also lists 1 linked publication.
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 30 Jan 2015.