Clinical trial NCT03274063: Gout Self-Monitoring Aiming to Reach Target
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gout
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised in a ratio of 2:1 to either supported self management or usual care.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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 (Gout Self-monitoring Aiming to Reach Target urate) 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

Primary outcomes:
measure: Percentage of Participants Achieving Target Urate Levels (24 Weeks)
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of Participants Achieving Target Urate Levels (52 Weeks)
timeFrame: 52 weeks
measure: Flare Frequency
timeFrame: 52 weeks
measure: Presence of Tophi
timeFrame: 52 weeks
measure: EQ-5D-5L Quality of Life Score
timeFrame: 52 weeks
measure: Work Absences
timeFrame: 52 weeks
measure: Healthcare Utilisation
timeFrame: 52 weeks
measure: Self-reported Medication Compliance (24 Weeks)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
Study officials:
affiliation: University of Edinburgh/NHS Lothian
name: Philip L Riches, FRCP PhD
role: PRINCIPAL_INVESTIGATOR
References: