Rheumatoid Arthritis Through Education and US Study (RAEUS) (RAEUS)

January 27, 2015 updated by: Medicine, National University Hospital, Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education with ultrasonography
Intervention includes education of self-assessment of synovitis using ultrasonography as a feedback training tool
Behavioral: Education using ultrasonography as feedback tool
Education using ultrasonography as feedback tool
No Intervention: Standard Care
Normal standard care where patients are not taught how to self-assess for synovitis, without ultrasonography a training tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence-adjusted bias adjusted kappa, PABAK>0.6
Time Frame: at 6 months
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bland and Altman 95% limits of agreement
Time Frame: 6 months
swollen joint count agreement
6 months
Level of satisfaction
Time Frame: 6 months
Likert response, satisfaction survey
6 months
disease activity score in 28 joints (DAS28)
Time Frame: 6 months
composite score that measures disease activity incorporating tender joint count, swollen joint count, erythrocyte sedimentation rate and patient global assessment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Peter Cheung, National University Hospital, Rheumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/01611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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