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| Name | Class |
|---|---|
| The Swedish Rheumatism Ass | OTHER |
| County Council of Halland, Sweden | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatologist-led clinic | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-led clinic vs rheumatologist-led clinic | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| DAS28 and costs for the clinics respectively. | Baseline at 0 months, 6 months, 12 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Bergman, MD, PhD | Contact | +46-35 2635250 | stefan.bergman@spenshult.se | |
| Ingrid Larsson, RN, PhD-stud | Contact | +46-35 2635253 | ingrid.larsson@spenshult.se |
| Name | Affiliation | Role |
|---|---|---|
| Ingrid Larsson, RN, PhD-stud | R&D-centre Spenshult | Principal Investigator |
| Stefan Bergman, MD, PhD | R&D-centre Spenshult | Study Director |
| Barbro Arvidsson, RNT, prof |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spenshult Hospital | Recruiting | Oskarström | Oskarström | S-31392 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26573936 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D057184 | Practice Patterns, Nurses' |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| R&D-centre Spenshult |
| Study Chair |
| Bengt Fridlund, RNT, prof | University of Jönköping, Sweden | Study Chair |