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临床试验/NCT00711152
NCT00711152已完成4 期

Inclusion Of a Community Health Worker in a Collaborative Diabetes Care Program Reduces Health Care Utilization (JADE)

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 661 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
661
试验地点
1
主要终点
Change in glycated hemoglobin level

研究概览

简要总结

  1. To recruit 600 type 2 diabetic patients managed in a community setting.
  2. To enrol into the Joint Asia Diabetes Evaluation (JADE) Program.
  3. All patients will undergo annual comprehensive assessment (CA) at a diabetes centre with personalized JADE report (JADE) at basline. Half of the randomized patients will be managed with additional support by a trained community health worker (CHW) (JADE+CHW).
  4. All patients will undergo annual comprehensive assessments for comparison of attainment of treatment targets for 3 years

详细描述

Several lines of evidence support protocol-driven care using a multidisciplinary approach with special focus on periodic assessments, reinforcement of compliance and attainment of treatment targets improves risk factor control and reduces morbidity and mortality in people with diabetes mellitus The Joint Asia Diabetes Evaluation (JADE) Program is an innovative project using state of the art information technology with internet on-line system to enable doctors, nurses and other medical personnel to manage people with diabetes. It provides a virtual platform to facilitate implementation of evidence-based clinical protocols and to collect, manage and analyse data to track performance for quality assurance and improvement purposes. The JADE Program incorporates validated risk equations developed by the CUHK Diabetes Care & Research Group to stratify patients into various risk clusters for recommendation into different care protocols. This information can be relayed to people with diabetes in an interactive manner, in the form of charts and time trends, to motivate changes in behaviour and to attain treatment targets.

In this implementation project, we aim to recruit 600 type 2 diabetic patients managed in a community setting. With written informed consent, these patients will be invited to enrol into the JADE Program. All patients will undergo annual comprehensive assessment (CA) at a diabetes centre with personalized JADE report (JADE) for 3 years. Half of the patients will be managed according to the JADE protocol implemented with additional support by a trained CHW (JADE+CHW). Guided by the personalized report with embedded decision support, the CHW will reinforce treatment adherence and self care after each clinic visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Patients with confirmed diagnosis of type 2 diabetes, aged 18 years or above, attending the Hospital Authority Ma On Shan Family Medicine Clinic in New Territory East Cluster
  • Type 2 diabetes is defined as follows:
  • Known history of type 2 diabetes with treatment such as lifestyle modification and/or anti-diabetic drugs for 6 months or more.
  • WHO diagnostic criteria (2 abnormal results in asymptomatic subjects or 1 abnormal result in subjects with symptoms or diabetic complications:
  • Fasting plasma glucose (PG) 7.0 mmol/L or above
  • Random PG 11.1 mmol/L or above
  • Post 75 g oral glucose tolerance test (OGTT) 2-hour PG 11.1 mmol/L or above

排除标准

  • Type 1 diabetes defined as history of ketosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or heavy ketonuria (>3+) or continuous requirement of insulin treatment within one year of diagnosis and thereafter.
  • Patients with terminal malignancy or other life-threatening diseases with less than 6-month expected survival
  • Telephone contact not available
  • Patients with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

结局指标

主要结局

Change in glycated hemoglobin level

时间窗: 3 years

次要结局

  • Cardio-metabolic control(3 years)
  • Number of emergency visits(3 years)
  • Hospitalizations with total length of stay(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juliana Chan

Chair Professor of Medicine and Therapeutics

Chinese University of Hong Kong

研究点 (1)

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