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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)
  1. Maxime Dougados1,
  2. Martin Soubrier2,
  3. Elodie Perrodeau3,
  4. Laure Gossec4,
  5. Françoise Fayet2,
  6. Mélanie Gilson5,
  7. Marie-Hélène Cerato6,
  8. Sophie Pouplin7,
  9. René-Marc Flipo8,
  10. Laurent Chabrefy9,
  11. Gael Mouterde10,
  12. Liana Euller-Ziegler11,
  13. Thierry Schaeverbeke12,
  14. Bruno Fautrel13,
  15. Alain Saraux14,
  16. Isabelle Chary-Valckenaere15,
  17. Gérard Chales16,
  18. Emmanuelle Dernis17,
  19. Pascal Richette18,
  20. Xavier Mariette19,
  21. Francis Berenbaum20,
  22. Jean Sibilia21,
  23. Philippe Ravaud22
  1. 1Rhumatologie B, Cochin Hospital, Paris, France; rené Descartes University INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, France
  2. 2Department of Rheumatology, CHU Clermont-Ferrand, Clermont-Ferrand, France
  3. 3Department of Epidemiology, INSERM U738, APHP, Hôtel-Dieu Hospital, Paris, France
  4. 4Rheumatology Department, UPMC, Univ Paris 06, APHP, Pitié-Salpêtrière Hospital, Paris, France
  5. 5Department of Rheumatology, CHU Sud Hospital, Grenoble, France
  6. 6Department of Rheumatology, Purpan Hospital, Toulouse, France
  7. 7Department of Rheumatology, Bois-Guillaume CHU, Rouen, France
  8. 8Department of Rheumatology, CHU Roger Salengro Hospital, University of Lille 2, Lille, France
  9. 9Department of Rheumatology, Marseille, France
  10. 10Department of Rheumatology, Lapeyronie Hospital, Montpellier, France
  11. 11Department of Rheumatology, L'Archet Hospital, NICE, France
  12. 12Department of Rheumatology, Pellegrin Hospital, Bordeaux, France
  13. 13Department of Rheumatology, APHP, Pitié-Salpêtrière Hospital, Paris, France
  14. 14Department of Rheumatology, and EA2216, CHU Brest, Université de Bretagne Occidentale, France
  15. 15Department of Rheumatology, Nancy Hospital, Nancy, France
  16. 16Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes, France
  17. 17Department of Rheumatology, Le Mans Hospital, Le Mans, France
  18. 18Université Paris Diderot, UFR médicale, Paris , France; APHP Hôpital Lariboisiére, Fédération de Rhumatologie, Paris, France
  19. 19Department of Rheumatology, APHP, Bicêtre Hospital, Le Kremlin-Bicetre, France
  20. 20Department of Rheumatology, Univ Paris 06 and INSERM UMRS_938, DHU i2B, APHP Saint- Antoine Hospital, Paris, France
  21. 21Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg, France
  22. 22Department of Epidemiology, APHP, Bichat Hospital, Paris, France
  1. Correspondence to Professor Maxime Dougados, Rhumatologie B, Cochin Hospital, 27 rue du Fbg Saint-Jacques, Paris 75014, France; maxime.dougados{at}


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.

  • Cardiovascular Disease
  • Rheumatoid Arthritis
  • Nursing

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