NCT01071447

Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment

Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Spenshult Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rheumatic Diseases

Interventions

Type	Name	Description
OTHER	Nurse-led clinic vs rheumatologist-led clinic	The subjects are seeing a rheumatology nurse (experimental arm)instead of a rheumatologist (active comparator arm) after six months. Subjects in both arms are seeing a rheumatologist after 12 months and have the possibility to contact the rheumatology nurse.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-10-01
• Completion: 2012-10-01
• First posted: 2010-02-19
• Last updated: 2010-08-18

Locations

1 site across 1 country: Sweden