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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treat-to-target | Experimental | All participants will have the GoutSMART application installed on their phones, and be offered a management plan including the use of flare prophylaxis and maximum advised dose of allopurinol based on renal function. All Participants in the treat-to-target group will be provided with a BeneCheck hand-held device and taught to perform urate finger prick self-testing. Participants will be prompted to submit urate readings by the GoutSMART app and if urate levels remain above target their allopurinol will be increased incrementally up to the pre-specified maximum dose of allopurinol. |
|
| Usual care | Active Comparator | All participants will have the GoutSMART application installed on their phones, and be offered a management plan including the use of flare prophylaxis and maximum advised dose of allopurinol based on renal function to achieve urate target. Participants in the usual care arm of the study will have their treatment reviewed and escalated by their GPs in line with usual practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treat-to-target | Other | Treatment to achieve urate target using supported self-management approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants flare free in 2nd year of trial | Proportion of participants flare free in 2nd year of trial | 2nd year of trial |
| Measure | Description | Time Frame |
|---|---|---|
| Number of flares of gout | Number of flares of gout in year 1, year 2 and over whole course of trial | 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip L Riches, FRCP, PhD | Contact | +44 7944625313 | philip.riches@nhs.scot | |
| Jo-Anne Robertson | Contact | 0131 242 3326 | resgov@accord.scot |
| Name | Affiliation | Role |
|---|---|---|
| Philip L Riches, FRCP, PhD | NHS Lothian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Lothian | Recruiting | Edinburgh | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38294032 | Background | Riches PL, Alexander D, Hauser B, Kuske B, Krause A. Evaluation of supported self-management in gout (GoutSMART): a randomised controlled feasibility trial. Lancet Rheumatol. 2022 May;4(5):e320-e328. doi: 10.1016/S2665-9913(22)00062-5. Epub 2022 Mar 24. |
| Label | URL |
|---|---|
| University of Edinburgh trial website | View source |
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Individual participant data that underlie results of specified outcomes will be shared after deidentification.
Deidentified information will be made available immediately following publication of trial results and be kept available for 5 years.
Researchers who provide a methodologically sound proposal.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2025 | Mar 20, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2025 | Mar 20, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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Randomized clinical trial
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| Usual Care | Other | Treatment escalation by GP based on usual clinical practice |
|
| 2 years |
| Presence of tophi | Proportion of participants with tophi at week 52 and 104 | 2 years |
| Societal cost | Number of days lost at work and number of medical appointments or hospital admissions due to gout | 2 years |
| Time to remission | Time to last flare of gout and time to resolution of tophi | 2 years |
| User engagement | User engagement with smartphone app (number of reminders needed for each submission) | 2 years |
| Medication prescriptions | Medication compliance assessed by community prescriptions issued | 2 years |
| Quality of life using SF-36 questionnaire | 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) | 2 years |
| Activity limitation | Functional impact assessed with HAQ-DI questionnaire at week 52 and 104 | 2 years |
| Medication compliance | Medication compliance assessed by patient self-report at week 52 and 104 | 2 years |
| Cost-effectiveness | Cost per flare avoided | 2 years |
| Cost-Utility | Cost per quality adjusted life year gained | 2 years |
| Patient attitudes and understanding | Exploration of patient attitudes and understanding through qualitative interview | 2 years |
| 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 |