Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
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.
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 Design
Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Conditions
Rheumatic Diseases
Intervention
Nurse-led clinic vs rheumatologist-led clinic
Location
Spenshult Hospital
Oskarström
Sweden
S-31392
Status
Recruiting
Source
Spenshult Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01071447
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Outpatients
Persons who receive ambulatory care at an outpatient department or clinic without room and board being provided.
Dental Waste
Any waste product generated by a dental office, surgery, clinic, or laboratory including amalgams, saliva, and rinse water.
Advanced Practice Nursing
Evidence-based nursing, midwifery and healthcare grounded in research and scholarship. Practitioners include nurse practitioners, clinical nurse specialists, nurse anesthetists, and nurse midwives.
Rheumatic Heart Disease
Cardiac manifestation of systemic rheumatological conditions, such as RHEUMATIC FEVER. Rheumatic heart disease can involve any part the heart, most often the HEART VALVES and the ENDOCARDIUM.
Nursing, Team
Coordination of nursing services by various nursing care personnel under the leadership of a professional nurse. The team may consist of a professional nurse, nurses' aides, and the practical nurse.
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