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临床试验/NCT03274063
NCT03274063已完成不适用

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

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Percentage of Participants Achieving Target Urate Levels (24 Weeks)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Laboratory staff measuring biochemical traits will be blind to treatment allocation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Subject is unable to provide consent
  • Severe renal failure (eGFR <30) or established liver disease
  • Previous adverse reaction to allopurinol or febuxostat

结局指标

主要结局

Percentage of Participants Achieving Target Urate Levels (24 Weeks)

时间窗: 24 weeks

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

次要结局

  • Flare Frequency(52 weeks)
  • Proportion of Participants Achieving Target Urate Levels (52 Weeks)(52 weeks)
  • Presence of Tophi(52 weeks)
  • EQ-5D-5L Quality of Life Score(52 weeks)
  • Healthcare Utilisation(52 weeks)
  • Work Absences(52 weeks)
  • Self-reported Medication Compliance (24 Weeks)(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philip Riches

Consultant Rheumatologist & Honorary Senior Lecturer

University of Edinburgh

研究点 (2)

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