Rheumatoid Arthritis Through Education and US Study (RAEUS)

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: Education using ultrasonography as feedback tool

• Registration Number: NCT02351401
• Lead Sponsor: National University Hospital, Singapore

Brief 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. 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 Timeline

• Study Start: 2011-11
• Primary Completion: 2012-11
• Study Completion: 2013-10
• Status Verified: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-27
• Last Update Submitted: 2015-01-27
• Study First Posted: 2015-01-30
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education with ultrasonography	Education using ultrasonography as feedback tool	Intervention includes education of self-assessment of synovitis using ultrasonography as a feedback training tool

Primary Outcome Measures

Name	Time	Method
prevalence-adjusted bias adjusted kappa, PABAK>0.6	at 6 months

Secondary Outcome Measures

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