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Rheumatoid Arthritis Through Education and US Study (RAEUS)

NCT ID: NCT02351401

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Education with ultrasonography

Intervention includes education of self-assessment of synovitis using ultrasonography as a feedback training tool

Group Type EXPERIMENTAL

Education using ultrasonography as feedback tool

Intervention Type BEHAVIORAL

Education using ultrasonography as feedback tool

Standard Care

Normal standard care where patients are not taught how to self-assess for synovitis, without ultrasonography a training tool

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education using ultrasonography as feedback tool

Education using ultrasonography as feedback tool

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* RA patients fulfilling ACR1987 criteria
* adults between age 21 and 80 years

Exclusion Criteria

* pregnant
* no mental health illness
* fit to perform informed consent
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Medicine

Dr Peter Cheung

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Cheung

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Rheumatology

References

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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.

Reference Type DERIVED
PMID: 25477057 (View on PubMed)

Other Identifiers

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2011/01611

Identifier Type: -

Identifier Source: org_study_id