Background The current T2T and EULAR recommendations (e.g. measures of disease activity must be obtained and documented regularly . Nurses should promote self-management skills in order that patients might achieve a greater self efficacy and improvement ) are difficult to apply in daily practice
Objectives To evaluate the impact of a nurse led program of patient self-assessment of disease activity on the management of Rheumatoid Arthritis (RA).
Methods Study design: Prospective, randomized, controlled, open, 6-month trial (NCT #0131652).Participants 1/Patients: Consecutive RA attending a clinic of the 20 participating centers were invited .2/ Nurses :all participated at a 1.5 day training session prior the start of the study. 3/Treating rheumatologists: aware of the study but not of its primary objective.
Study treatment: a program including: 1) a video explaining both the interest, calculation and interpretation of the DAS28-ESR, 2) Training of a self joint assessment, 3) A booklet and a calculator permitting the patient to report the results of his/her “auto” DAS28-ESR and to show the results to his/her treating rheumatologist.
Treatment allocation:After written informed consent, the treatment was allocated randomly via en electronic system (e.g. either this above program or an evaluation of potential co-morbidities (not reported here). Outcome variables:Primary: percentage of patients with a change in DMARD therapy during the 6 months follow-up period. Other variables: changes in symptomatic parameters.
Results There was no difference in the baseline characteristics of the 970 recruited patients (488 and 482 in the active and control groups respectively): Age: 58±11 years, female gender: 79%, disease duration: 11[6.2-19.1] years, DAS28-ESR: 3.1±1.3, mHAQ: 0.25[0.00-0.62]; RAID: 2.7[1.3-4.3]. At the month 6 visit, the % patients bringing back a completed booklet was 89%. During the 6 months follow-up period, a DMARD therapy was changed in 17.2% vs. 10.9% in the active vs. control group (p=0.0012) (OR=1.70 [1.17-2.19]). During the time of the study, there was no statistically significant inter-group differences (-0.10 [-0.10;0.3], p=0.41; -0.03 [-0.25; 0.18], p=0.761; -0.01 [-0.05; 0.04], p=0.806, in the DAS28-ESR, HAQ and RAID in the active vs. control group respectively.
Conclusions This study demonstrates the short term impact of a nurse leaded patient self assessment of RA disease activity program. Longer term follow up of patients is required to better evaluate the clinical benefit of this program
Smolen J.S. et al; Ann Rheum Dis 2010; 69, 631-7
Van Eijk-Hustings y. et al. Ann Rheum Dis. 2012; 71, 13-9
Acknowledgements This study was conducted thanks to a grant from the French National Research Program ( PHRC) and thanks to an unrestricted grant from Roche Ltd France
Disclosure of Interest None Declared
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