Impact of a nurse-led programme on comorbidity management and impact of a patient self-assessment of disease activity on the management of rheumatoid arthritis: results of a prospective, multicentre, randomised, controlled trial (COMEDRA)

Maxime Dougados, Martin Soubrier, Elodie Perrodeau, Laure Gossec, Françoise Fayet, Mélanie Gilson, Marie-Hélène Cerato, Sophie Pouplin, René-Marc Flipo, Laurent Chabrefy, Gael Mouterde, Liana Euller-Ziegler, Thierry Schaeverbeke, Bruno Fautrel, Alain Saraux, Isabelle Chary-Valckenaere, Gérard Chales, Emmanuelle Dernis, Pascal Richette, Xavier Mariette, Francis Berenbaum, Jean Sibilia, Philippe Ravaud, Maxime Dougados, Martin Soubrier, Elodie Perrodeau, Laure Gossec, Françoise Fayet, Mélanie Gilson, Marie-Hélène Cerato, Sophie Pouplin, René-Marc Flipo, Laurent Chabrefy, Gael Mouterde, Liana Euller-Ziegler, Thierry Schaeverbeke, Bruno Fautrel, Alain Saraux, Isabelle Chary-Valckenaere, Gérard Chales, Emmanuelle Dernis, Pascal Richette, Xavier Mariette, Francis Berenbaum, Jean Sibilia, Philippe Ravaud

Abstract

Objectives: Rheumatoid arthritis (RA) patients are at an increased risk of developing comorbid conditions. A close monitoring of the disease targeting a status of low disease activity is associated with a better outcome. The aim of this trial was to evaluate the impact of a nurse-led programme on comorbidities and the impact of patient self-assessment of disease activity on the management of RA.

Methods: We enrolled 970 patients (mean age 58 years, 79% women) in a prospective, randomised, controlled, open-label, 6-month trial. In the comorbidity group (n=482), the nurse checked comorbidities and sent the programme results to the attending physicians. In the self-assessment group (n=488), the nurse taught the patient how to calculate his/her Disease Activity Score which had to be reported on a booklet to be shared with the treating rheumatologist. The number of measures taken for comorbidities and the percentage of patients recording a change (initiation, switch or increased dose) in disease-modifying antirheumatic drugs (DMARDs) in the 6 months follow-up period of the study defined the outcomes of the trial.

Results: The number of measures taken per patient was statistically higher in the comorbidity group: 4.54±2.08 versus 2.65±1.57 (p<0.001); incidence rate ratio: 1.78 (1.61-1.96) and DMARD therapy was changed more frequently in the self-assessment group: 17.2% versus 10.9% (OR=1.70 (1.17; 2.49), p=0.006).

Conclusions: This study demonstrates the short-term benefit of a nurse-led programme on RA comorbidity management and the impact of patient self-assessment of disease activity on RA treatment intensification.

Trial registration number: NCT #01315652.

Trial registration: ClinicalTrials.gov NCT01315652.

Keywords: Cardiovascular Disease; Nursing; Rheumatoid Arthritis.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Figures

Figure 1
Figure 1
Study of flowchart.
Figure 2
Figure 2
Number of measures against comorbidities.
Figure 3
Figure 3
Percentage of patients with an intensification of their disease-modifying antirheumatic drug (DMARD) therapy during the 6 months of the COmorbidities, EDucation in Rheumatoid Arthritis (COMEDRA) trial.

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Source: PubMed

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