Rheumatic Diseases
Conditions
Keywords
Rheumatic diseases, Biologic treatment, Nurse-led
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.
Interventions
OTHERNurse-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.
Sponsors
The Swedish Rheumatism Ass
County Council of Halland, Sweden
Spenshult Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28 and costs for the clinics respectively. | Baseline at 0 months, 6 months, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Sweden
Contacts
Primary ContactStefan Bergman, MD, PhD
Backup ContactIngrid Larsson, RN, PhD-stud
Outcome results
None listed