Clinical trial NCT01071447: Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
Official title: Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment:a Randomized Controlled Trial Comparing Nurse-led Clinic Versus Rheumatologist Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatic Diseases
Keywords: Rheumatic diseases
Biologic treatment
Nurse-led
Lead sponsor: Spenshult Hospital
Sponsor class: OTHER
Collaborators: name: The Swedish Rheumatism Ass
name: County Council of Halland, Sweden
First posted: 2010-02-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: DAS28 and costs for the clinics respectively.
timeFrame: Baseline at 0 months, 6 months, 12 months
Secondary outcomes:
measure: 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.
timeFrame: Baseline at 0 months, 6 months, 12 months
Other outcomes:
Locations:
city: Oskarström
country: Sweden
facility: Spenshult Hospital
Study officials:
affiliation: R&D-centre Spenshult
name: Ingrid Larsson, RN, PhD-stud
role: PRINCIPAL_INVESTIGATOR
affiliation: R&D-centre Spenshult
name: Stefan Bergman, MD, PhD
role: STUDY_DIRECTOR
affiliation: R&D-centre Spenshult
name: Barbro Arvidsson, RNT, prof
role: STUDY_CHAIR
affiliation: University of Jönköping, Sweden
name: Bengt Fridlund, RNT, prof
role: STUDY_CHAIR
References:
citation: Larsson I, Fridlund B, Arvidsson B, Teleman A, Svedberg P, Bergman S. A nurse-led rheumatology clinic versus rheumatologist-led clinic in monitoring of patients with chronic inflammatory arthritis undergoing biological therapy: a cost comparison study in a randomised controlled trial. BMC Musculoskelet Disord. 2015 Nov 16;16:354. doi: 10.1186/s12891-015-0817-6.