Rheumatoid Arthritis
Conditions
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.
Interventions
BEHAVIORALEducation using ultrasonography as feedback tool
Education using ultrasonography as feedback tool
Sponsors
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prevalence-adjusted bias adjusted kappa, PABAK>0.6 | at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed