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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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Purpose: To compare a nurse-led clinic including person-centered care and tight control with "care as usual" in patients with rheumatoid arthritis (RA) and moderate/ high disease activity.
Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high Disease Activity Score of 28 joints (DAS28 > 3.8) and disease duration > 2 yrs in a 6-month randomized controlled study with a 6 month open follow-up. Intervention group (N=60): Nurse-led visits every 6th week, with structured person-centered care and evaluation of disease activity. If disease remission is not reached, pharmacological treatment including both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and biologics) is modified according to a predefined algorithm. The control group (N=60) is treated according to "care as usual" with visits to physician every 6th month. Outcome measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary outcomes are quality of life, self-efficacy, disability, emotional well-being, pain, fatigue, sleep and satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular care | No Intervention | The control-group is treated according to "care as usual" with visits to physician every 6th month. | |
| Nurse-led clinic | Experimental | Nurse-led visits every 6th week, with structured person-centered care and evaluation of disease activity. If disease remission is not reached, pharmacological treatment including both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and biologics) is modified according to a predefined algorithm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-led clinic | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease activity score (DAS28) | The primary outcome constitute of DAS28, an index comprising the number of tender and swollen joints, patients global health assessment and erythrocyte sedimentation rate | Baseline, week 26 and 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with low Disease activity score (DAS28) | Baseline, week 26 and 50 | |
| Proportion of patients with remisson according to Disease activity score (DAS28) | Baseline, week 26 and 50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lennart Jacobsson, Professor | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31219668 | Derived | Bergsten U, Almehed K, Baigi A, Jacobsson LTH. A randomized study comparing regular care with a nurse-led clinic based on tight disease activity control and person-centred care in patients with rheumatoid arthritis with moderate/high disease activity: A 6-month evaluation. Musculoskeletal Care. 2019 Sep;17(3):215-225. doi: 10.1002/msc.1403. Epub 2019 Jun 20. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic 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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| Health assessment questionnaire (HAQ) | Measures functional status | Baseline, week 26 and 50 |
| EuroQol (EQ-5D) | Measures health status, allowing computation of cost-effectiveness | Baseline, week 26 and 50 |
| Visual analogue scale for pain (VAS-pain) | Measures the patient's pain | Baseline, week 26 and 50 |
| Visual analogue scale fatigue (VAS-Fatigue) | Measures the patient's fatigue. | Baseline, week 26 and 50 |
| Visual analogue scale general health (VAS-general health) | Measures the patient's general health. | Baseline, week 26 and 50 |
| Effective Consumer Survey 17 (EC17) | Measures patients' perception of their knowledge, attitudes and behaviors about self-management skills | Baseline, week 26 and 50 |
| Rheumatoid Arthritis Impact of Disease (RAID) score, | A patient-derived composite measure of the impact of the disease | Baseline, week 26 and 50 |
| The beliefs about medicines questionnaire (BMQ) | Assessing patients' perceptions and expectation about medicines | Baseline,week 26 and 50 |
| Numerical Rating Scale (NRS) about satisfaction with care | Measures satisfaction with rheumatology care | Baseline, week 26 and 50 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |