A randomized study comparing regular care with a nurse‐led clinic based on tight disease activity control and person‐centred care in patients with rheumatoid arthritis with moderate/high disease activity: A 6‐month evaluation

INTRODUCTION: A recent survey showed that 27% of rheumatoid arthritis (RA) patients had inadequately controlled disease activity. Hence, there is a need for new strategies aiming at improving patient outcomes. The aim of the present study was to evaluate the effect of a nurse‐led clinic with frequent visits, treat‐to‐target and person‐centred care of patients with established RA and moderate‐to‐high disease activity compared with patients receiving regular care. METHODS: The study was a randomized, controlled trial over 26 weeks, with a nonrandomized extension to week 50. Patients were randomized to an intervention group (IG; nurse‐led clinic) based on person‐centred care, frequent visits and “treat to target”, or to a control group (CG) which visited the clinic according to care as usual. The primary outcome was the difference in the DAS28 change between the IG and the CG groups. RESULTS: A total of 332 patients were screened for eligibility, of which 70 were randomly assigned to either the IG (n = 36) or the CG (n = 34) group. The primary outcome was not met, although patients in the IG group tended to improve more than those in the CG group (difference: 0.43 (95% confidence interval [CI] –0.27, 1.13). In both the IG and CG groups, delta‐DAS28 improved significantly. The European League Against Rheumatology moderate or good response was achieved by 76% (95% CI 58, 89) in the IG and 49% (95% CI 32, 65) in the CG group. CONCLUSIONS: Disease activity tended to improve more with the nurse‐led intervention compared with regular care, although the difference was not significant, probably partly due to the lack of statistical power.