Rheumatic Diseases Clinical Trial
Official title:
Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic
Randomized controlled trial including 100 subjects with rheumatic diseases and biological treatment with a 28 point-Disease Activity Score(DAS28)3.2 or less. The subjects will be randomized to either nurse-led clinic or rheumatologist-led clinic. The hypothesis is that there will be no difference in DAS28 between the two groups after 1 year follow-up.
Aim To compare nurse-led clinic and rheumatologist-led clinic regarding results of
treatment, and health economic costs.
Intervention Rheumatologist-led clinic: The subjects are seeing a rheumatologist after six
months and after 12-months of intervention and have the possibility to contact the
rheumatology clinic.
Nurse-led clinic: The subjects are seeing a rheumatology nurse after six months and a
rheumatologist after 12 months of intervention and have the possibility to contact the
rheumatology nurse during the intervention.
Outcome measures:
Main outcome: DAS28 and costs for the clinics respectively.
Secondary outcome: HAQ (Health Assessment Questionnaire), VAS-pain (Visual Analog Scale),
VAS-global health, VAS-satisfaction, VAS-security/trust, Tender joints, swollen joints,
Quality of life-EQ5D, Effective consumer survey 17, Inflammatory parameters in blood.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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