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Gout is secondary to urate crystal deposition after chronic elevation of serum urate level (SUL). Long-term lowering SUL below 360 µmol/L allows dissolution of deposited crystals and disease cure. There is currently a paradoxical observation: while urate-lowering therapy (ULT) is available and efficient there is an increase of gout prevalence and severity. The apparent failure of ULT in gout management is due to several causes including unadjusted dosage, no SUL verification, irregular follow-up and low treatment compliance.
In contrast, a nurse-led treat-to-target (T2T) strategy with regular adaptations of ULT until reaching SUL target allows gout cure in more than 90% of patients. We hypothesize that an electronic messaging-led T2T strategy will allow obtaining similar results.
The aim of this study is to demonstrate that email-led T2T strategy during ULT is superior to usual care.
The study will include 204 gouty patients without ULT or with ineffective ULT. This is a multicenter and randomized study (e-mail follow-up vs usual follow-up groups).
This study will include the following visits:
Selection/inclusion visit (V0):
Follow-up visits: consultations will be carried out according to the usual care of the referring physician.
Visit M12 end of research: clinical evaluation of gout, demographic characteristics, medication, type and dose of ULT, blood analysis (serum creatinine level, eGFR, SUL).
The study ends after the M12 consultation. The total duration of participation in the study is 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-mail follow-up group | Experimental | Email-led treat-to-target strategy with regular adaptation of ULT via electronic messaging |
|
| Usual follow-up group | Active Comparator | Adaptation and follow-up of ULT according to referring physician's habits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cleanweb electronic messaging ePro | Other | Patient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout) | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Average dose of ULT (allopurinol and febuxostat) | Month 12 |
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Inclusion Criteria:
Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL > 360 μmol/l during the crisis (3.5 pts)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital LARIBOISIERE - Rhumatologie | Paris | 75010 | France | |||
| Rhumathology department |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D012213 | Rheumatic Fever |
| D033461 | Hyperuricemia |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| Usual follow-up | Other | Adaptation and follow-up of ULT according to referring physician's habits |
|
| Paris |
| Île-de-France Region |
| 75010 |
| France |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |