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临床试验/NCT01274364
NCT01274364已完成不适用

China-JD Program: A Multi-centre Demonstration Project to Evaluate the Effectiveness and Acceptability of the Joint Asia Diabetes Evaluation (JADE) and DIAbetes MONitoring Database (DIAMOND) Programs in Asian Type 2 Diabetic Patients

Asia Diabetes Foundation1 个研究点 分布在 1 个国家目标入组 3,586 人开始时间: 2010年1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
3,586
试验地点
1
主要终点
Percentage of patients who attain 2 or more of the 'ABC' targets

研究概览

简要总结

Quality diabetes care requires a team approach and informed decisions of patients and care providers. Several lines of evidence suggests that a protocol-driven care model delivered by trained staff with focus on periodic assessments, reinforcement of patient compliance and attainment of multiple treatment targets reduces risk of cardio-renal complications and early death in type 2 diabetes.

The investigators hypothesize that the use of state of the art information technology to record, manage and analyze the large amount of clinical information generated during various consultation visits will improve the effectiveness and efficiency in implementing these care protocols through decision support and regular feedback to both patients and care team.

详细描述

Diabetes is now a pandemic disease affecting 5-10% of global population. More than 60% of affected people will come from Asia with the number expected to increase from 85 million in 2005 to 132 million in 2010 in Asia alone. On average, diabetes reduces life expectancy by 10-12 years. While stroke, heart disease and kidney failure account for more than 50% of global deaths, 30-50% of patients with these conditions have diabetes as a major contributing factor. In contrast to the West, the main increase in diabetes prevalence in Asia will occur in the young to middle aged population. On average, 17 million people die from stroke and heart disease on a yearly basis. Of these, 11 million occur in Asia, affecting many young parents and economically active people.

Despite their devastating nature, many diabetic complications can be prevented and managed effectively to preserve health, reduce disabilities and improve quality of life. However, there are multiple barriers in the implementation of quality diabetes care. These include insufficient knowledge base of health care professionals, fragmented nature of health care systems, lack of reimbursement for outpatient procedures including therapeutic patient education, poor compliance to treatment in part due to the silent nature of diabetes and associated complications as well as the complex nature of care protocols. The latter include periodic evaluation of clinical and laboratory parameters and the need for people with diabetes to adhere to long term medications and self care.

While optimal management of risk factors and treatment to targets can substantially reduce the risk of diabetes associated complications, the challenge lies in the effective translation of this evidence to clinical practice. Since mid 1990s, inspired by the benefits of structured care, made possible during the conduct of clinical trials, the CUHK Diabetes Care & Research Group has developed prototypes of structured care protocols including an annual comprehensive assessment using a doctor-nurse-physician assistant team. Consistent with international data, these prototypes substantially improve rates of treatment compliance and attainment of multiple treatment targets resulting in reduced death and cardio-renal complication rates.

The Joint Asia Diabetes Evaluation (JADE) Program is a web-based disease management program conceptualized, developed and tested by the Asia Diabetes Foundation (ADF) since 2007, supported by a MSD educational grant. The objectives of the JADE Program include:

  1. to promote collective learning and sharing of best practices in diabetes based on regionally relevant evidence
  2. to increase regional awareness about the magnitude of diabetes and its preventable nature through education, ongoing data collection and implementation of evidence-based guidelines
  3. to establish a regional diabetes registry
  4. to collect the evidence base to inform relevant stakeholders including public, people with diabetes, health care professionals, policy makers and payors to change policies and practices in order to make quality diabetes care accessible, sustainable and affordable.

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

入选标准

  • Type 2 diabetic patients attending hospitals or affiliated clinics led by PIs of the JADE Program who are living in the area with an intention to have 'regular' follow-up
  • Aged >18 years
  • Patients can have newly diagnosed or established disease, treated with lifestyle or blood glucose lowering drugs including oral agents with or without insulin
  • For newly diagnosed type 2 diabetic patients, their plasma glucose levels should be: a) Fasting plasma glucose (PG) >7.0 mmol/L on 2 or more occasions, and/or b) Random (or post-OGTT 2h) PG >11.1 mmol/L on 2 or more occasions, and/or c) HbA1c >6.5%

排除标准

  • Type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis
  • Patients with reduced life expectancy (e.g. less than 6-months) due to recent diagnosis of advanced cancers (e.g. within last 2 years) and other life threatening conditions
  • Patients with a mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
  • Patients actively enrolled in another intervention study
  • Patients who are unwilling to return for regular follow up

结局指标

主要结局

Percentage of patients who attain 2 or more of the 'ABC' targets

时间窗: 12 months

Percentage of patients who attain 2 or more of the following 3 targets: * HbA1c \<7% * BP \<130/80 mmHg * LDL cholesterol \<2.6 mmol/L

次要结局

  • Default rates at end of study(12 months)
  • Frequency of hypoglycaemia (in the last 3 months)(12 months)
  • Number of hospitalizations, follow up visits by doctors and other care professionals(12 months)
  • Quality of Life(12 months)
  • Behavioral changes (in the last 3 months)(12 months)
  • New onset of all diabetes-related endpoints(12 months)

研究者

发起方
Asia Diabetes Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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