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临床试验/NCT00935441
NCT00935441已完成不适用

Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes

Minneapolis Veterans Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2009年6月1日最近更新:
适应症

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

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

发起方
Minneapolis Veterans Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Nacide Ercan-Fang

Principal Investigator

Minneapolis Veterans Affairs Medical Center

研究点 (2)

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