NCT00569556已完成不适用
Effect of Care Management on Diabetes Outcomes
Minneapolis Veterans Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2006年9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
- 550
- 试验地点
- 2
- 主要终点
- Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals
研究概览
简要总结
The purpose of the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C<8.0%, LDL<100mg/dl, and BP<130/80mmHG) by 10% compared to usual care.
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
- •Enrolled at Minneapolis VAMC
- •Type 1 or 2 diabetes
- •Blood pressure at screening visit > 140mmHg systolic or > 90mmHg diastolic OR HgbA1C at screening visit > 9.0% OR LDL at screening visit > 100mg/dL
排除标准
- •Primary care provider unwilling to have participant included in study
- •Life expectancy < 1 year
- •Unable to give consent
- •Severe mental health condition
- •pregnant or planning on becoming pregnant
结局指标
主要结局
Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals
时间窗: one year
次要结局
- Safety of the intervention (occurence of adverse events over the course of the trial)(one year)
研究者
研究点 (2)
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