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This study evaluates the addition of a structured nurse led patient management programme to standard of care in gout patients. Half of the patient will receive the nurse led programme in addition to standard of care and the other half will receive standard of care only.
There is evidence from other chronic diseases that nurse led care in addition to standard of care ameliorates outcomes.
In gout the primary target is the serum uric acid level (SUA). We intend to demonstrate the superiority of a structured nurse led patient management programme over standard of care in a randomized controlled study.
The primary endpoint is the percentage of patients reaching the target SUA level at 6 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse led plus standard of care | Experimental | Nurse Led Patient Management Programme to Improve Outcomes in Gout and Standard of care for gout patients, including nurse delivered patient education and follow up |
|
| Standard of care | No Intervention | Standard of care for gout patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nurse led plus standard of care | Other | structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum uric acid level at 6 months Follow-up | percentage of patients who reach the SUA target level of 360 umol/l | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Longterm achievement of the target SUA at 12 months | percentage of patients who reach the SUA target level of 360 umol/l | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Daikeler, Prof. Dr. med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Basel | Canton of Basel-City | 4030 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26352873 | Result | Neogi T, Jansen TL, Dalbeth N, Fransen J, Schumacher HR, Berendsen D, Brown M, Choi H, Edwards NL, Janssens HJ, Liote F, Naden RP, Nuki G, Ogdie A, Perez-Ruiz F, Saag K, Singh JA, Sundy JS, Tausche AK, Vazquez-Mellado J, Yarows SA, Taylor WJ. 2015 Gout Classification Criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheumatol. 2015 Oct;67(10):2557-68. doi: 10.1002/art.39254. |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D001168 | Arthritis |
| D000070657 | Crystal Arthropathies |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Interventional group: structured nurse led patient management programm & sc Control group standard of care (sc) alone
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| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |