Gout Self-Monitoring Aiming to Reach Target (Gout-SMART)

University of Edinburgh

Status: Completed

Conditions: Gout

Treatments: Other: Supported self-management; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03274063

GoutSMART_NHSL_2YCR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Supported self-management

Active Comparator group

Description:

Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing

Treatment:

Other: Supported self-management

Usual care

Sham Comparator group

Description:

Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.

Treatment:

Other: Usual care