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

Not Applicable

• Conditions: Rheumatic Diseases
• Interventions: Other: Nurse-led clinic vs rheumatologist-led clinic

• Registration Number: NCT01071447
• Lead Sponsor: Spenshult Hospital

Brief 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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-17
• Last Update Posted: 2010-08-18
• Primary Completion: 2011-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Subjects with rheumatologic diseases and biological treatment with a DAS28 of 3.2 or less

Exclusion Criteria

• The subjects should not have problems with infections due to treatment
• Subjects with difficulties speaking and/or reading swedish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rheumatologist-led clinic	Nurse-led clinic vs rheumatologist-led clinic	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	Nurse-led clinic vs rheumatologist-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.

Primary Outcome Measures

Name	Time	Method
DAS28 and costs for the clinics respectively.	Baseline at 0 months, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
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.	Baseline at 0 months, 6 months, 12 months

Trial Locations

Locations (1)

Spenshult Hospital; 🇸🇪 Oskarström, Sweden