Cleanweb electronic messaging ePro
OtherPatient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached
NCT Number: NCT04733079
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Rhumathology department, Paris, Île-de-France Region, France
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:
The study ends after the M12 consultation. The total duration of participation in the study is 12 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Patient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached
Adaptation and follow-up of ULT according to referring physician's habits
Time frame: Month 12
Time frame: Month 12
Assistance Publique - Hôpitaux de Paris
Other
Acronym: GOUTEmail
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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