Rheumatoid Arthritis Through Education and US Study (RAEUS)

National University Health System (NUHS)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Behavioral: Education using ultrasonography as feedback tool

Study type: Interventional

Funder types: Other

Identifiers

NCT02351401

2011/01611

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Education with ultrasonography

Experimental group

Description:

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

Treatment:

Behavioral: Education using ultrasonography as feedback tool

Standard Care

No Intervention group

Description:

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