A Structured Nurse Led Patient Management Programme to Improve Outcomes in Gout: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Serum uric acid level at 6 months Follow-up
研究概览
简要总结
This study evaluates the addition of a structured nurse led patient management programme to standard of care in gout patients. Half of the patient will receive the nurse led programme in addition to standard of care and the other half will receive standard of care only.
详细描述
There is evidence from other chronic diseases that nurse led care in addition to standard of care ameliorates outcomes.
In gout the primary target is the serum uric acid level (SUA). We intend to demonstrate the superiority of a structured nurse led patient management programme over standard of care in a randomized controlled study.
The primary endpoint is the percentage of patients reaching the target SUA level at 6 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven diagnosis of gout according to aspiration of Monosodium urate (MSU) crystals or positive dual energy computer tomography (DECT) or American college of rheumatology (ACR) criteria 2015 fulfilled (1)
- •written informed consent
- •age >=18 years
- •ability and willingness to follow a fixed outpatient programme as judged by the investigator
- •indication for urate-lowering therapy (ULT)
- •In case of established disease and intercritical gout a SUA level over 360 umol per liter is mandatory.
排除标准
- •informed consent not obtained
- •age <18 years
- •inability or unwillingness to follow a fixed outpatient programme as judged by the investigator
- •no definite diagnosis of Gout
- •no indication for ULT or contraindications against ULT
- •in case of established disease and intercritical gout a SUA level <360 umol per liter is an exclusion criterion
- •Pregnant or breastfeeding women can´t participate.
结局指标
主要结局
Serum uric acid level at 6 months Follow-up
时间窗: 6 months
percentage of patients who reach the SUA target level of 360 umol/l
次要结局
- Longterm achievement of the target SUA at 12 months(12 months)