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

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

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.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Other: Supported self-management; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supported self-management; Escalation of urate lowering therapy will be supervised by clinical research team based on results of participant self-testing	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 .
Sham Comparator: Usual care; Escalation of urate lowering therapy will remain the responsibility of the participants primary care physician.	Other: Usual care; Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	Number of self-reported gout flares (months 7 to 12)	52 weeks
Presence of Tophi	Percentage of participants with tophi at 52 weeks	52 weeks
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
Work Absences	Number of days lost at work due to gout flare	52 weeks
Healthcare Utilisation	Number of scheduled and unscheduled medical appointments	52 weeks
Self-reported Medication Compliance (24 Weeks)	Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks.	24 weeks

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Investigators: Principal Investigator: Philip L Riches, FRCP PhD, University of Edinburgh/NHS Lothian

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Actual): March 19, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: September 3, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
• Other Study ID Numbers: GoutSMART_NHSL_2YCR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available on request.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No