Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
NCT Number: NCT03274063
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Edinburgh, EH4 2XU, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 .
Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
Time frame: 24 weeks
Percentage of participants achieving serum urate level at, or below, 0.3mmol/l
Time frame: 52 weeks
Proportion of participants achieving serum urate level at, or below, 0.3mmol/l
Time frame: 52 weeks
Number of self-reported gout flares (months 7 to 12)
Time frame: 52 weeks
Percentage of participants with tophi at 52 weeks
Time frame: 52 weeks
EQ-5D-5L (EuroqQol-5 level-5 dimension) self-reported quality of life score. Maximum score of 100 represents best possible health, minimum score of 0 represents worst possible health.
Time frame: 52 weeks
Number of days lost at work due to gout flare
Time frame: 52 weeks
Number of scheduled and unscheduled medical appointments
Time frame: 24 weeks
Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks.
University of Edinburgh
Other
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
Acronym: Gout-SMART
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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