Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients in Gout (Pharm-UP) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 310
- 试验地点
- 5
- 主要终点
- serum urate at goal
研究概览
简要总结
This study will compare two different approaches to manage medications that lower uric acid levels. This study will be conducted at five VA medical centers across the United States and will take 4-5 years to complete. Individual participation will last up to two years.
详细描述
This project will quantify and compare the effects of a pharmacist-led telehealth-delivered intervention versus usual care on arthritis flare burden and serum urate goal achievement in 310 U.S. Veterans with gout enrolled from five VA medical centers. The project will quantify the effects of the intervention on patient-reported outcomes (improvements in health-related quality of life, pain interference, and participant global assessment).
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
- None
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
- •US Veterans over the age of 18 years with physician-diagnosed
- •Documented hyperuricemia (SU >6.8 mg/dL)
- •Satisfy ACR/EULAR gout classification criteria
- •Report 1 or more flares in the prior 6 months
- •Receipt of a new ULT prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare/SU criteria
排除标准
- •Any patient intolerant or unable to take ULTs (allopurinol or febuxostat)
- •Patients with a rheumatology encounter within the prior 3 months
研究组 & 干预措施
Pharmacist-Led
Veterans will participate in regular telehealth visits with study pharmacists. Serum urate lab tests will be ordered during dose escalation phase of gout treatment.
干预措施: Pharmacist-Led (Other)
Usual care
Veterans will receive standard care from their primary care provider for the management of their gout.
结局指标
主要结局
serum urate at goal
时间窗: at end of year one
Achievement of serum urate \<6 mg/dL at end of year one.
flare occurrence
时间窗: during year two
The occurrence of two or more flares during year 2.
次要结局
- Veterans RAND 12 (VR-12)(Baseline visit, Months 6, 12, 18, and 24)
- Patient Reported Outcomes Measurement Information System (PROMIS)(Baseline visit, Months 6, 12, 18, and 24)
- Gout-related patient global assessment(Baseline visit, Months 6, 12, 18, and 24)