title: 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).
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT #01315652.
authors.affiliation: Rhumatologie B, Cochin Hospital, Paris, France; rené Descartes University INSERM (U1153): Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, France.
authors.forename: Maxime
authors.initials: M
authors.lastname: Dougados
authors.affiliation: Department of Rheumatology, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors.forename: Martin
authors.initials: M
authors.lastname: Soubrier
authors.affiliation: Department of Epidemiology, INSERM U738, APHP, Hôtel-Dieu Hospital, Paris, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: Perrodeau
authors.affiliation: Rheumatology Department, UPMC, Univ Paris 06, APHP, Pitié-Salpêtrière Hospital, Paris, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Gossec
authors.affiliation: Department of Rheumatology, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Fayet
authors.affiliation: Department of Rheumatology, CHU Sud Hospital, Grenoble, France.
authors.forename: Mélanie
authors.initials: M
authors.lastname: Gilson
authors.affiliation: Department of Rheumatology, Purpan Hospital, Toulouse, France.
authors.forename: Marie-Hélène
authors.initials: MH
authors.lastname: Cerato
authors.affiliation: Department of Rheumatology, Bois-Guillaume CHU, Rouen, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Pouplin
authors.affiliation: Department of Rheumatology, CHU Roger Salengro Hospital, University of Lille 2, Lille, France.
authors.forename: René-Marc
authors.initials: RM
authors.lastname: Flipo
authors.affiliation: Department of Rheumatology, Marseille, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Chabrefy
authors.affiliation: Department of Rheumatology, Lapeyronie Hospital, Montpellier, France.
authors.forename: Gael
authors.initials: G
authors.lastname: Mouterde
authors.affiliation: Department of Rheumatology, L'Archet Hospital, NICE, France.
authors.forename: Liana
authors.initials: L
authors.lastname: Euller-Ziegler
authors.affiliation: Department of Rheumatology, Pellegrin Hospital, Bordeaux, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Schaeverbeke
authors.affiliation: Department of Rheumatology, APHP, Pitié-Salpêtrière Hospital, Paris, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Fautrel
authors.affiliation: Department of Rheumatology, and EA2216, CHU Brest, Université de Bretagne Occidentale, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Saraux
authors.affiliation: Department of Rheumatology, Nancy Hospital, Nancy, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Chary-Valckenaere
authors.affiliation: Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes, France.
authors.forename: Gérard
authors.initials: G
authors.lastname: Chales
authors.affiliation: Department of Rheumatology, Le Mans Hospital, Le Mans, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Dernis
authors.affiliation: Université Paris Diderot, UFR médicale, Paris , France; APHP Hôpital Lariboisiére, Fédération de Rhumatologie, Paris, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Richette
authors.affiliation: Department of Rheumatology, APHP, Bicêtre Hospital, Le Kremlin-Bicetre, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.affiliation: Department of Rheumatology, Univ Paris 06 and INSERM UMRS_938, DHU i2B, APHP Saint- Antoine Hospital, Paris, France.
authors.forename: Francis
authors.initials: F
authors.lastname: Berenbaum
authors.affiliation: Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Sibilia
authors.affiliation: Department of Epidemiology, APHP, Bichat Hospital, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
mesh_terms: D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000453:epidemiology / Q000628:therapy*; D015897:Comorbidity; D003920:Diabetes Mellitus / Q000453:epidemiology; D019468:Disease Management; D050171:Dyslipidemias / Q000453:epidemiology; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology; D006801:Humans; D006973:Hypertension / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D057184:Practice Patterns, Nurses'; D012648:Self Care / Q000379:methods*; D016353:Self-Examination / Q000379:methods; D012907:Smoking / Q000453:epidemiology
chemical_list: D018501:Antirheumatic Agents
keywords: Cardiovascular Disease; Nursing; Rheumatoid Arthritis