NHS Lothian
Edinburgh, United Kingdom
Location status: Recruiting
Location contact
Philip Riches
CONTACT
NCT Number: NCT05507723
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Edinburgh, United Kingdom
Location status: Recruiting
Philip Riches
CONTACT
A total of approximately 125 participants will be recruited. We anticipate that most participants will be identified following referral to rheumatology outpatient or on-call services in National Health Service (NHS) Lothian, or through NHS Lothian's gout liaison service. Additional patients may indicate their willingness to participate directly in response to study advertisements.
Based on baseline renal function and flare frequency, an individual treatment plan will be drawn up for all participants which will set a ceiling on the maximum dose of allopurinol to be used within the trial and determine the need for flare prophylaxis with colchicine. Participants will be randomized to the intervention group in a 1:1 ratio, with stratification by the need for use of flare prophylaxis.
All participants will have a smart phone application (GoutSMART) uploaded to their smart phones. Usual care participants will have a limited version of the GoutSMART application installed which includes background information about gout and provides a means for participants to maintain diaries of gout flares. Subjects in the usual care arm of the study will have treatment escalation decisions made by their GPs. Subjects in the treat-to-target arm will be taught to self-test serum urate using a BeneCheck Plus hand held device and provided with test strips. A full version of the GoutSMART application will be installed with the features mentioned above but also the facility to record a urate diary. Participants will be prompted to check their serum urate and enter the results into the GoutSMART application. Participants reporting a urate level >0.3mmol/l will be advised to increase the dose of allopurinol incrementally as specified in their treatment plan. No change will be advised in those whose urate levels are already at target. If the patient needs to increase allopurinol there will be an automatic reminder after two weeks prompting the patients to submit updated self-test results which will be handled in the same way as described above. Conversely for participants achieving target levels this will be acknowledged and a request to resubmit readings will be sent on a monthly basis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment to achieve urate target using supported self-management approach
Treatment escalation by GP based on usual clinical practice
Time frame: 2nd year of trial
Proportion of participants flare free in 2nd year of trial
Time frame: 2 years
Number of flares of gout in year 1, year 2 and over whole course of trial
Time frame: 2 years
Proportion of participants achieving urate levels of ≤0.3mmol/L or ≤0.36mmol/L at 52 and 104wks
Time frame: 2 years
Proportion of participants with tophi at week 52 and 104
Time frame: 2 years
Number of days lost at work and number of medical appointments or hospital admissions due to gout
Time frame: 2 years
Time to last flare of gout and time to resolution of tophi
Time frame: 2 years
User engagement with smartphone app (number of reminders needed for each submission)
Time frame: 2 years
Medication compliance assessed by community prescriptions issued
Time frame: 2 years
Self-reported quality of life at week 52 and week 104 using SF 36 questionnaire. Global health score (0 to 100 score with 100 representing best possible health)
Time frame: 2 years
Functional impact assessed with HAQ-DI questionnaire at week 52 and 104
Time frame: 2 years
Medication compliance assessed by patient self-report at week 52 and 104
Time frame: 2 years
Cost per flare avoided
Time frame: 2 years
Cost per quality adjusted life year gained
Time frame: 2 years
Exploration of patient attitudes and understanding through qualitative interview
Contact information is provided by the study sponsor or research team.
Jo-Anne Robertson
CONTACT
Philip L Riches, FRCP, PhD
CONTACT
University of Edinburgh
Other
Effect of Tight Urate Control in Gouty Arthritis Compared to Usual Care (TICOGA), a Randomised Clinical Trial
Acronym: TICOGA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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