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

Spenshult Hospital

Status: Unknown

Conditions: Rheumatic Diseases

Treatments: Other: Nurse-led clinic vs rheumatologist-led clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT01071447

FoUS09001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rheumatologist-led clinic

Active Comparator group

Description:

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

Treatment:

Other: Nurse-led clinic vs rheumatologist-led clinic

Nurse-led clinic

Experimental group

Description:

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.

Treatment:

Other: Nurse-led clinic vs rheumatologist-led clinic