About this trial
Gout is caused by a reaction to urate crystals that results in attacks of severe joint pain. Medicines that lower urate levels can prevent gout flares, however it takes time for this benefit to be felt, and paradoxically starting treatment with large doses of urate lowering treatment risks provoking attacks of gout. Medical guidelines disagree on the best way to overcome these challenges with many recommending medicine dose adjustment based on regular urate testing but a general practice guideline suggesting more simply increasing the medicine dose in those patients that continue to suffer flares. In reality most patients are not treated at all, and many of those that are treated never receive an effective dose of treatment. We have developed a supported self-management approach to gout in which patients monitor their own urate levels using a finger prick test, and then receive advice on adjusting their treatment dose to achieve target urate levels through a smartphone app (Gout SMART). A trial of this approach has shown that it results in much better control of urate levels after 6 months than usual care, and suggests that it also leads to fewer flares. We would now like to confirm that this approach is effective in reducing flares of gout over 2 years by randomising patients to either treatment-to-target urate using our self-monitoring approach, or to usual care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of informed consent.
Age ≥18 years.
Patient has sustained at least one flare of gout in the previous 12 months.
Confirmed clinical diagnosis of gout as per ACR/EULAR criteria
Disqualifiers
Subject unable to provide consent
Patient on maximum urate lowering therapy or where therapy cannot be escalated further due to intolerance/adverse reaction to either allopurinol or febuxostat.
End stage renal failure/transplant
Current prescription of medication known to interact with xanthine oxidase inhibitors such as azathioprine or mercapto-purine.
Trial design
Parallel
Treatments tested in this trial
Treat-to-target
Other interventionTreatment to achieve urate target using supported self-management approach
Usual Care
Other interventionTreatment escalation by GP based on usual clinical practice
Treatment groups
Trial outcomes
Primary outcomes
Proportion of participants flare free in 2nd year of trial
Proportion of participants flare free in 2nd year of trial
Secondary outcomes
Number of flares of gout
Number of flares of gout in year 1, year 2 and over whole course of trial
Urate targets of ≤0.3mmol/L or ≤0.36mmol/L
Proportion of participants achieving urate levels of ≤0.3mmol/L or ≤0.36mmol/L at 52 and 104wks
Presence of tophi
Proportion of participants with tophi at week 52 and 104
Societal cost
Number of days lost at work and number of medical appointments or hospital admissions due to gout
Sponsors and contacts
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