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临床试验/NCT00109720
NCT00109720已完成不适用

Evaluation of Diabetes Self-Management Consultant Care

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)4 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2002年8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
310
试验地点
4
主要终点
Blood glucose level

研究概览

简要总结

The purpose of this study is to find out if Self-Management Consultant (SMC) intervention will be more effective than usual care in improving blood glucose control and diabetes-related quality of life for adults with type 2 diabetes.

详细描述

This study is designed to compare the effectiveness of a diabetes Self-Management Consultant (SMC) intervention for adults with type 2 diabetes with unsatisfactory glucose control (i.e., HbA1c ≥ 8%--the value chosen as "high risk" by the Diabetes Quality Improvement Project which is an initiative of the Health Care Financing Administration, the American Diabetes Association, and the Foundation for Accountability) to a control group selected using the same criteria. The SMC intervention will be implemented and evaluated in two different health care systems serving two distinct populations of patients with diabetes. After signing the Informed Consent document, subjects will be randomized to the SMC intervention or a control group. All subjects in the study will complete a baseline assessment of their diabetes care and health status.

Subjects randomized to the SMC intervention will have an individual meeting with the SMC to review and refine a self-management plan based on the subject's priorities and goals. These subjects will receive individual follow-up and support during the year, through monthly phone calls and an annual meeting with the SMC and their primary care physician. Subjects randomized to the control group will receive usual care following their baseline and their 12-, 24-, and 36-month assessments. Unlike most nurse-manager studies, the SMC's interactions with patient care will use a theory-based behavioral approach with which we have extensive experience. The study is designed to evaluate the effectiveness of the SMC intervention compared to usual care.

All records will be handled confidentially. Lab results and personal data will be linked by a research specific identifier code.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over age 21 diagnosed with type 2 diabetes for at least one year.

排除标准

  • Patients under psychiatric care
  • Currently pregnant
  • Those who have not been diagnosed with type 2 diabetes

结局指标

主要结局

Blood glucose level

时间窗: two years

次要结局

  • Diabetes Related Quality of life(two years)

研究者

研究点 (4)

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