Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Controlled Study Evaluating the Efficacy of Person-centered, Tight Control Nurse-led Clinic of Patients With Established Rheumatoid Arthritis and Moderate to High Disease Activity Compared to Patients Receiving Regular Care
Purpose: To compare a nurse-led clinic including person-centered care and tight control with
"care as usual" in patients with rheumatoid arthritis (RA) and moderate/ high disease
activity.
Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high
Disease Activity Score of 28 joints (DAS28 > 3.8) and disease duration > 2 yrs in a 6-month
randomized controlled study with a 6 month open follow-up. Intervention group (N=60):
Nurse-led visits every 6th week, with structured person-centered care and evaluation of
disease activity. If disease remission is not reached, pharmacological treatment including
both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and
biologics) is modified according to a predefined algorithm. The control group (N=60) is
treated according to "care as usual" with visits to physician every 6th month. Outcome
measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary
outcomes are quality of life, self-efficacy, disability, emotional well-being, pain,
fatigue, sleep and satisfaction.
n/a
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