Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 601
- 试验地点
- 2
- 主要终点
- composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)
研究概览
简要总结
The purpose of this study is to determine if the adoption of a chronic care model in conjunction with tele monitoring and case management can reduce the risk of death, hospitalization, emergency room visits, or admission to a skilled nursing facility in patients with chronic kidney disease compared to usual care.
详细描述
Chronic kidney disease (CKD) is a major public health issue. Approximately, 11% of the US population has CKD with an increased prevalence among individuals great than 65years. Many individuals with CKD go unrecognized because they are typically asymptomatic. Individuals with CKD have been demonstrated to have a greater risk for mortality, hospitalization and development of end stage kidney disease. Also, individuals with CKD consume a significantly greater proportion of health care expenditures compared to other patients. This study aims to determine if the adoption of a chronic care model in conjunction with telemonitoring and case management can reduce risk of death, hospitalization, ER visits or admission to a skilled nursing facility in patients with CKD compared to usual care. This study will use a randomized controlled trial. Few interventions have been demonstrated to improve clinical outcomes in patients with CKD. If successful, this study will enable the VA to provide high quality care to patients with CKD while potentially reducing the cost of providing care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled at Minneapolis or St. Cloud Veterans Affairs Health Care System (VAHCS) or affiliated Community Based Outcomes Clinic(CBOC); Late eGFR within the VA system <60 ml/min/1.73m2 -
排除标准
- •Primary care provider unwilling to have participant included in study; unable to give consent; severe mental health condition; living in a nursing home
结局指标
主要结局
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)
时间窗: one year
次要结局
- reduction of cost(one year)
- incidence of end stage kidney disease(one year)
- hospital re-admission(one year)
- Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin(one year)
研究者
Areef Ishani
Chief, Section of Nephrology; Associate Professor of Medicine
Minneapolis Veterans Affairs Medical Center