Rheumatoid Arthritis Clinical Trial
— RAEUSOfficial title:
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | October 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | prevalence-adjusted bias adjusted kappa, PABAK>0.6 | at 6 months | No | |
Secondary | Bland and Altman 95% limits of agreement | swollen joint count agreement | 6 months | No |
Secondary | Level of satisfaction | Likert response, satisfaction survey | 6 months | No |
Secondary | disease activity score in 28 joints (DAS28) | composite score that measures disease activity incorporating tender joint count, swollen joint count, erythrocyte sedimentation rate and patient global assessment | 6 months | No |
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