Gout Self-Monitoring Aiming to Reach Target

Gout Clinical Trial

— Gout-SMART  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274063
• Other study ID #: GoutSMART_NHSL_2YCR
• Status: Completed
• Phase: N/A
• Start date: April 5, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

Other:
• Supported self-management
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 .
• Usual care
Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.

Locations

Country	Name	City	State
United Kingdom	Western General Hospital	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Target Urate Levels (24 Weeks)	Percentage of participants achieving serum urate level at, or below, 0.3mmol/l	24 weeks
Secondary	Proportion of Participants Achieving Target Urate Levels (52 Weeks)	Proportion of participants achieving serum urate level at, or below, 0.3mmol/l	52 weeks
Secondary	Flare Frequency	Number of self-reported gout flares (months 7 to 12)	52 weeks
Secondary	Presence of Tophi	Percentage of participants with tophi at 52 weeks	52 weeks
Secondary	EQ-5D-5L Quality of Life Score	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.	52 weeks
Secondary	Work Absences	Number of days lost at work due to gout flare	52 weeks
Secondary	Healthcare Utilisation	Number of scheduled and unscheduled medical appointments	52 weeks
Secondary	Self-reported Medication Compliance (24 Weeks)	Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks.	24 weeks