Clinical Trials Directory

Trials / Completed

CompletedNCT02351401

Rheumatoid Arthritis Through Education and US Study (RAEUS)

Improvement in Patient Awareness and Ability to Assess Disease in Rheumatoid Arthritis: Rheumatoid Arthritis Through Education and US Study (RAEUS)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
101 (actual)
Sponsor
National University Hospital, Singapore · Academic / Other
Sex
All
Age
21 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEducation using ultrasonography as feedback toolEducation using ultrasonography as feedback tool

Timeline

Start date
2011-11-01
Primary completion
2012-11-01
Completion
2013-10-01
First posted
2015-01-30
Last updated
2015-01-30

Source: ClinicalTrials.gov record NCT02351401. Inclusion in this directory is not an endorsement.