Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Glycemic control (HbA1c)
研究概览
简要总结
This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled at Minneapolis VAMC,
- •Type 1 or 2 Diabetes,
- •HbA1c >8.5%,
- •active land-line telephone connection
排除标准
- •Age >75 years,
- •primary care provider unwilling to have patient enrolled,
- •active dialysis,
- •resident of assisted living facility,
- •research participant in previous diabetes case management study,
- •life expectancy <1 year,
- •severe mental health condition,
- •active substance abuse,
- •pregnant or planning on becoming pregnant
结局指标
主要结局
Glycemic control (HbA1c)
时间窗: 9 months after enrollment
次要结局
- Systolic blood pressure control in patients with elevated blood pressure at baseline(9 months after enrollment)
研究者
Nacide Ercan-Fang
Principal Investigator
Minneapolis Veterans Affairs Medical Center
