Rheumatoid Arthritis Through Education and US Study (RAEUS)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: Education using ultrasonography as feedback tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bland and Altman 95% limits of agreement | swollen joint count agreement | 6 months | 
| Level of satisfaction | Likert response, satisfaction survey | 6 months | 
| 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 |