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)

Ann Rheum Dis. 2015 Sep;74(9):1725-33. doi: 10.1136/annrheumdis-2013-204733. Epub 2014 May 28.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / epidemiology
  • Arthritis, Rheumatoid / therapy*
  • Comorbidity
  • Diabetes Mellitus / epidemiology
  • Disease Management
  • Dyslipidemias / epidemiology
  • Female
  • Fractures, Bone / epidemiology
  • Humans
  • Hypertension / epidemiology
  • Male
  • Middle Aged
  • Patient Outcome Assessment
  • Practice Patterns, Nurses'
  • Self Care / methods*
  • Self-Examination / methods
  • Smoking / epidemiology

Substances

  • Antirheumatic Agents

Associated data

  • ClinicalTrials.gov/NCT01315652