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临床试验/NCT00394875
NCT00394875已完成不适用

The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes in a Secondary Care Setting: a Randomized Controlled Trial.

Medical Research Foundation, The Netherlands1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2002年3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
81
试验地点
1
主要终点
mean decrease in:

研究概览

简要总结

To determine whether the management of type 2 diabetes mellitus (DM2) can be transferred from an internist to a supervised nurse specialized in diabetes (NSD) with a comparable quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.

详细描述

Diabetes mellitus type 2 (DM2) is a chronic, progressive illness which causes considerable morbidity and premature mortality.1-2 The worldwide prevalence of DM2 is high and is increasing steadily, also in The Netherlands.3-4 The burden of DM2 on health care has also increased because of the intensified cardiovascular risk management being practiced to prevent macrovascular morbidity and mortality in these patients.5 In the treatment of DM2, tight guidelines are increasingly recommended for optimizing glycaemia, blood pressure and lipid profile.6 Therefore, the burden of treatment has increased and will further increase per patient as well as per population with DM2. In order to meet this problem, we tested, in the current study, the hypothesis that well defined routine aspects in diabetes care, previously handled only by medical doctors in secondary care setting, may be safely transferred to supervised nurses specialized in diabetes (NSD), including the prescription of medication, resulting in at least the same quality of clinical care, health care costs, health related quality of life (HRQOL), and patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •patients with DM2 who were referred by GPs to the diabetes outpatient clinics

排除标准

  • •macroalbuminuria
  • •serum creatinine level > 135 mol/l,
  • •Cockcroft < 50 ml/min
  • •alanine aminotransferase (ALT) > 120 U/l
  • •pregnant woman

结局指标

主要结局

mean decrease in:

HbA1c

blood pressure

total cholesterol

LDL cholesterol

cholesterol/HDL-ratio

proportion of patients achieving ranges of:

glycaemic control

lipid profile

次要结局

  • health related quality of life (HRQOL)
  • diabetes related symptoms
  • patients' satisfaction
  • health care consumption and costs

研究者

发起方
Medical Research Foundation, The Netherlands
申办方类型
Other

研究点 (1)

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