跳至主要内容
临床试验/NCT01568879
NCT01568879已完成不适用

Evaluating the Effectiveness of a Chronic Disease Management Program for Gout

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
Serum Uric Acid Level

研究概览

简要总结

The aim of this study is to test the effectiveness of a pharmacist-staffed, protocol-based chronic disease management program compared to patients receiving usual care in achieving a target serum uric acid level in patients with recurrent gout.

详细描述

Gout is a chronic condition with intermittent symptoms and should be managed through an outcome-based disease management approach. Unlike other common chronic conditions, strategies for population management in gout patients have not been tested. The study will identify adult members of Kaiser Permanente (KP) Northern California with a diagnosis of gout and 3 or more outpatient or Emergency Department visits for gout over a 1-year period preceding study enrollment. These patients will be randomized to either an active management group, or to usual care. The participants will be enrolled and followed over a period of 26 weeks. The primary outcome to be measured will be the attainment and maintenance of a uric acid lowering regimen targeted to achieve serum uric acid level of 6.0 mg/dl or less. The treatment protocol will use standard treatment guidelines to lower and maintain uric acid levels to less than or equal to 6.0 mg/dl (or maximum doses of uric acid lowering medications) and provide patient education and dietary counseling. Monitoring and medication management will be carried out by a licensed clinical pharmacist under the supervision of an experienced rheumatologist. Control subjects will have regular monitoring of serum uric acid levels and will be provided with educational material and dietary counseling, but otherwise receive usual care. The demonstration that a chronic disease management approach to gout care can improve the health and reduce morbidity in patients with gout may illuminate a simple path towards improved quality of life and reduced morbidity in this growing population of patients.

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
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Three or more outpatient/ED visits in a 24-month period prior to selection for study with one of these primary visit diagnoses:
  • Gouty arthropathy
  • Gout, unspecified
  • Gout with other specified manifestations
  • Tophaceous gout of ear (274.81) or other sites
  • Gouty nephropathy
  • At least 2 years of continuous Kaiser Foundation Hospital Plan membership
  • Baseline uric acid level above 7.0mg/dl

排除标准

  • Current cancer diagnosis with active treatment
  • End stage renal disease
  • Pregnant or lactating
  • Patients with a diagnosis of dementia
  • Terminally ill patients

结局指标

主要结局

Serum Uric Acid Level

时间窗: change from baseline at 6 months follow up

attainment and maintenance of a serum uric acid level of 6.0 mg/dl or less. The outcome will be considered positive if that level is attained and the 6 month follow up value remains at the target level.

次要结局

  • Serum Creatinine(0, 12, and 26 weeks)
  • Serum Alanine Aminotransferase (ALT)(0, 12, and 26 weeks)
  • Gout flares(0, 12, and 26 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验