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Completed

NCT Number: NCT03274063

Gout Self-Monitoring Aiming to Reach Target

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supported Self-Management

Other

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

Other

Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.

Primary outcomes

  1. Percentage of Participants Achieving Target Urate Levels (24 Weeks)

    Time frame: 24 weeks

    Percentage of participants achieving serum urate level at, or below, 0.3mmol/l

Secondary outcomes

  1. Proportion of Participants Achieving Target Urate Levels (52 Weeks)

    Time frame: 52 weeks

    Proportion of participants achieving serum urate level at, or below, 0.3mmol/l

  2. Flare Frequency

    Time frame: 52 weeks

    Number of self-reported gout flares (months 7 to 12)

  3. Presence of Tophi

    Time frame: 52 weeks

    Percentage of participants with tophi at 52 weeks

  4. EQ-5D-5L Quality of Life Score

    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.

  5. Work Absences

    Time frame: 52 weeks

    Number of days lost at work due to gout flare

  6. Healthcare Utilisation

    Time frame: 52 weeks

    Number of scheduled and unscheduled medical appointments

  7. Self-reported Medication Compliance (24 Weeks)

    Time frame: 24 weeks

    Number of doses of medication omitted in preceding 2 weeks by self-report at 24 weeks.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study 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

Acronym: Gout-SMART

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2017
Registry last updated
May 21, 2024

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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