Gout Self-Monitoring Aiming to Reach Target

Study Overview
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Brief Summary
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This study evaluates whether a supported self-management approach to gout is able to achieve target levels of serum urate, and better control of gout flares.

Detailed Description
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Gout is the most common cause of inflammatory arthritis with recurrent gout flares a cause of reduced quality of life, work absence and disability. Effective treatments are widely available and yet many patients never achieve control of their disease. Resolution of gout attacks requires sustained lowering of the levels of serum urate, which in practise is seldom achieved. A supported self-management approach to gout has been developed which incorporates self-testing of urate levels and a smartphone application that will prompt participants to self-test and allow clinical researchers to titrate urate lowering therapies. The feasibility of this approach will be evaluated in patients with gout referred to secondary care. Participants will be randomised 2:1 to the intervention or a control group. The intervention group will be offered supported self-management incorporating self-testing of serum urate. The control group will receive usual care from their primary care physician. The primary outcome will be the proportion of patients achieving levels of serum urate at or below 0.3mmol/l by 6 months. Participants will be followed up for a total of 12 months to assess the broader health and economic impact of the intervention.

Official Title
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Gout Self-Monitoring Aiming to Reach Target Serum Urate (Gout-SMART): Feasibility Study of Supported Self-management of Gout in Secondary Care Patients Requiring Escalation of Urate Lowering Therapy

Conditions
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Gout

Intervention / Treatment
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* Other: Supported self-management
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of gout (as per American College of Rheumatology criteria) Physician recommendation that escalation of urate lowering therapy with allopurinol or febuxostat is appropriate. Serum urate >0.36mm/L. Patient has a mobile phone and is able to install GoutSMART application. Exclusion Criteria: Subject is unable to provide consent Severe renal failure (eGFR <30) or established liver disease Previous adverse reaction to allopurinol or febuxostat

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supported self-management<br>Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing | Other: Supported self-management<br>* Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .<br>|
| Sham Comparator: Usual care<br>Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician. | Other: Usual care<br>* Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving target urate levels (24 weeks) | Proportion of participants achieving serum urate level at, or below, 0.3mmol/l | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants achieving target urate levels (52 weeks) | Proportion of participants achieving serum urate level at, or below, 0.3mmol/l | 52 weeks | 
| Flare frequency | Prospectively gathered number of days of self-reported gout flares | 52 weeks | 
| Size of tophi | The size in mm of the largest tophus at baseline (index tophus) will be measured at 52 weeks | 52 weeks | 
| Presence of tophi | The number of clinically evident tophi will be evaluated at 52 weeks | 52 weeks | 
| Patient reported quality of life using EQ-5D-5L | Prospectively gathered self-reported quality of life during/following gout flare evaluated using the EQ-5D-5L questionnaire. | 52 weeks | 
| Work absences | Prospectively gathered data on days lost at work due to gout flare | 52 weeks | 
| Healthcare utilisation | Prospectively gathered number of scheduled and unscheduled medical appointments/ hospital admissions due to gout | 52 weeks | 
| Self-reported medication compliance (24 weeks) | Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 24 weeks. | 24 weeks | 
| Self-reported medication compliance (52 weeks) | Self report of number of doses of medication omitted in preceding 2 weeks will be collected at 52 weeks | 52 weeks | 
| Medication compliance (24 weeks) | Plasma oxypurinol levels will be measured at 24 weeks. | 24 weeks | 
| Medication compliance (52 weeks) | Plasma oxypurinol levels will be measured at 52 weeks. | 52 weeks |