chronic joint inflammation Rheumatoid Arthritis
Conditions
Interventions
During the course of one year, various patient reported measures, such as the
Patient-based Disease Activity Score (P-DASII), the modified Rheumatoid
Arthritis Disease Activity Index (RADAI-5), the
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis RA according to the ACR criteria 2. Patients starting on either their first DMARD or biological therapy
Exclusion criteria
Exclusion criteria: Patients who are unable to complete the questionnaires/PDASII
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary focus of this study is the effect of training on the concurrent criterion validity of the PDASII. Primary outcome of the study will be the mean difference between the PDASII and DAS28 at 6, 9 and 12 months after baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be other clinimetric aspects of the PDASII: Validity - face/content; percentage found to be comprehensive and percentage missing elements - construct; convergent correlation analysis with other measures of disease activity and related components of health assessment questionnaires, discriminant correlation analysis with non-related components of health assessment questionnaires measures of disease activity and health state measures - criterion; with joint damage progression over the course of one year Reliability - intraobserver intra-class correlation coefficient Sensitivity to change - standardised response mean - effect size - minimal important difference (ROC + 75th percentile) Feasibility - average time to complete - average cost to complete - percentage positive interpretability - percentage full-completion Acceptance - percentage physicians and patients willing to use patient reported measure for monitoring | — |
Countries
Netherlands
Outcome results
None listed