Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
NCT ID: NCT01071447
Last Updated: 2010-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2009-10-31
2012-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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 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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects with difficulties speaking and/or reading swedish
ALL
No
Sponsors
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The Swedish Rheumatism Ass
OTHER
County Council of Halland, Sweden
OTHER_GOV
Spenshult Hospital
OTHER
Responsible Party
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R&D-centre Spenshult Hospital
Principal Investigators
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Ingrid Larsson, RN, PhD-stud
Role: PRINCIPAL_INVESTIGATOR
R&D-centre Spenshult
Stefan Bergman, MD, PhD
Role: STUDY_DIRECTOR
R&D-centre Spenshult
Barbro Arvidsson, RNT, prof
Role: STUDY_CHAIR
R&D-centre Spenshult
Bengt Fridlund, RNT, prof
Role: STUDY_CHAIR
University of Jönköping, Sweden
Locations
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Spenshult Hospital
Oskarström, Oskarström, Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Related Info
Other Identifiers
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FoUS09001
Identifier Type: -
Identifier Source: org_study_id
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