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

Ulrika Bergsten, Katarina Almehed, Amir Baigi, Lennart T H Jacobsson, Ulrika Bergsten, Katarina Almehed, Amir Baigi, Lennart T H Jacobsson

Abstract

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.

Trial registration: ClinicalTrials.gov NCT02019901.

Keywords: nursing; rheumatoid arthritis; self-management.

Conflict of interest statement

The authors declare that there are no conflicts of interest.

© 2019 The Authors Musculoskeletal Care published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Flow chart for enrolment. DAS28: Disease Activity Score in 28 joints; IG: intervention group [Colour figure can be viewed at http://wileyonlinelibrary.com]
Figure 2
Figure 2
Description of the contents of the visits in the intervention group. bDMARD: biologic disease‐modifying anti‐rheumatic drug; CRP: c‐reactive protein; csDMARD: conventional synthetic disease‐modifying anti‐rheumatic drug; DAS28: Disease Activity Score in 28 joints; ESR: erythrocyte sedimentation rate [Colour figure can be viewed at http://wileyonlinelibrary.com]
Figure 3
Figure 3
Trial profile. DAS28: Disease Activity Score in 28 joints; SRQ: Swedish Rheumatology Quality Register

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