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临床试验/NCT00950963
NCT00950963已完成不适用

Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics

Denver Health and Hospital Authority2 个研究点 分布在 1 个国家目标入组 762 人开始时间: 2005年9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
762
试验地点
2
主要终点
Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL

研究概览

简要总结

The current project is evaluating the effect of a nurse-administered phone care in diabetes to improve access to care and healthcare delivery. The setting is a federally qualified community health center serving over 1600 diabetic patients, 80% of whom are Latino. Using our diabetes registry, we have randomly assigned 762 patients to either participate in a telephone-based, nurse-run outreach program (N=381) or to continue with usual care(N=381). Three of our registered nurses learned algorithms addressing management of cholesterol, blood pressure, kidney disease, aspirin use, eye screening, and pneumovax and influenza vaccines. The program began recruitment in September 2005 and has finished follow up in May 2007. The program initially focused only on cholesterol management utilizing national guidelines and algorithms on patients with elevated cholesterol (LDL) levels but has expanded to include glycemic and blood pressure control. We found that Registered Nurses were able and willing to provide telephone care to diabetic patients according to moderately complex algorithms and to track patient data electronically with overall job satisfaction. Overall, the nurses have expressed enthusiasm but have also experience frustrations with maintaining contact and improving motivation in patients. The impact of this program on diabetes outcomes and its cost-effectiveness is currently being analyzed with the goal of implementing this program in our institution.

详细描述

This randomized, controlled trial tested the effectiveness of a nurse-run, telephone-based intervention to improve lipid control in patients with diabetes. Our patient population is predominantly low-income and Latino. Using our diabetes registry, we randomly assigned 381 patients to continue with their usual care and 381 to participate in our nurse run program. Three registered nurses learned algorithms for diabetes care. These algorithms address management of lipids, glycemic control, blood pressure, nephropathy, aspirin use, eye screening, pneumovax and influenza vaccines, obesity, and cigarette smoking. The nurses were also trained in motivational interviewing techniques and facilitation of patient self-management. The primary goal was to improve lipid control in our diabetic population. Secondary outcomes address blood pressure control, glycemic control, renal function, and medication adherence. In addition, a cost-effective analysis is being performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients included in Denver Health diabetes registry.
  • Type I and Type II diabetic patients
  • Age >17 years old
  • Actively utilizing Westside Clinic for their primary care (at least two visits in the past year)
  • Speak either English or Spanish.

排除标准

  • We sought to maximize the generalizability of the study and therefore had only minimal exclusion criteria:
  • Pregnant or lactating women
  • Patients with end-stage renal disease (creatinine > 3.0 mg/dl)
  • Patients with a co-morbid illness with life expectancy less than 12 months, (e.g. terminal cancer or Child's Class C hepatic cirrhosis).

结局指标

主要结局

Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL

时间窗: 18 months

Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study

次要结局

  • Number of CVD Patients With LDL Less Than 70 mg/dL.(18 months)
  • Number of Patients With BP Less Than 130/80 mm Hg(18 months)
  • Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study(18 months)

研究者

申办方类型
Other

研究点 (2)

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