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临床试验/NCT00824499
NCT00824499Unknown不适用

Development, Implementation and Evaluation of a Complex Regional Intervention for Type 2 Diabetes.

Universiteit Antwerpen0 个研究点目标入组 375 人开始时间: 2004年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
375
主要终点
HBA1C

研究概览

简要总结

The purpose of this study is to determine whether regional implementation of shared care with respect to type 2 diabetes is feasible, effective and cost-effective.

详细描述

Background Diabetes is an important chronic condition with significant associated morbidity and mortality, which can be reduced by effective care. An interdisciplinary approach, sharing responsibility and involvement and education of patients are of major importance in diabetes care.

In Belgium a research project aimed at creating regional diabetes shared care was set up.

Research questions

  • Is regional implementation of shared care feasible?
  • Does it increases quality of care (evidence based care) and patient satisfaction with care?
  • Does it have a positive effect on health status (emotional distress, overall quality of life, Hba1c)?

Methods Controlled trial (July 2004 - June 2006) with a regional complex intervention comprising introduction of a care-manager and 2 community based diabetes educators, development and implementation of a shared care protocol (with a central role for the GP), regional feedback on the quality of diabetes care and patient education. Practitioners and patients participate on a voluntary basis. In the control region usual care continues.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All type 2 diabetes patients living in the defined intervention region
  • All caregivers involved in type 2 diabetes care in the defined intervention region

排除标准

  • 未提供

结局指标

主要结局

HBA1C

时间窗: Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006

次要结局

  • Total Cholesterol(Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006)
  • LDL-C(Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006)
  • HDL-C(Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006)
  • microalb.(Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006)
  • blood creatinine(Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006)
  • ophthalmist consults(Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006)
  • Statine prescriptions(Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006)
  • Influenza Vaccination Prescriptions(Longitudinal analysis on measurements from 01/01/2004 until 31/12/2006)

研究者

申办方类型
Other

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