A Multicentre Randomized Program to Compare the Effect of the Joint Asia Diabetes Evaluation (JADE, Structured Care) Versus the DIAbetes MONitoring Database (DIAMOND, Usual Care) Programs in Type 2 Diabetes in the Asia Pacific Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20,834
- 试验地点
- 1
- 主要终点
- Incidence of all diabetes-related clinical endpoints
研究概览
简要总结
In this demonstration project (Asia Pacific JADE and DIAMOND Program, AP-JD in short) supported by the Asia Diabetes Foundation (ADF), patients will be recruited from different sites across Asia, with each site recruiting at least 600 type 2 diabetic patients. After explanation by trained doctors and nurses, and with written informed consent, patients will be randomized to either the JADE (n=300, structured care) or DIAMOND (n=300, usual care) group.
All patients will undergo a comprehensive assessment (CA) at baseline and yearly thereafter. Patients in the JADE group will be further managed by a doctor-nurse-HCA team according to a protocol based on risk stratification with predefined follow up (FU) schedules together with shared information and decision support (i.e. structured collaborative care). The DIAMOND protocol involves only baseline and yearly CA without predefined FU schedules or feedback of information between CA visits (i.e. usual care).
The primary composite endpoint is all-diabetes related clinical endpoints. The secondary composite endpoint is attainment of treatment goals and/or control of risk factors. The tertiary changes are behavioral changes, psychological well being and quality of life.
详细描述
Rationale: Change of practice environment and an interdisciplinary team is needed to implement evidence-based diabetes care which requires risk stratification, periodic assessments, education and treatment to targets.
Hypothesis: The use of a web-based disease management program (Joint Asia Diabetes Evaluation (JADE) Program) delivered by a doctor-nurse-HCA team reduces the incidence of all diabetes-associated clinical endpoint and improves control of risk factors compared to usual care (DIAbetes MONitoring Database (DIAMOND) group) in type 2 diabetes.
Objective: To compare structured care using the JADE portal versus usual care using the DIAMOND portal on incidence of all-diabetes related events, physical and psychological health.
Study design: A multicentre, randomized, integrated disease management program Setting and patients: 600 patients from each site will be randomized to the JADE group (n=300) or the DIAMOND group (n=300) and followed up for at least 24 months.
Intervention: All patients will undergo comprehensive assessment (CA) guided by the templates in the respective portal at baseline, month 12 and 24. The JADE group will be further managed by a doctor-nurse-HCA team guided by the JADE portal with risk stratification program and recommendation to different care protocols with predefined follow up (FU) schedules, information sharing and decision supports.
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
- 否
入选标准
- •Type 2 diabetic patients who are willing or can be persuaded to return for 'regular' follow-up at 3-4 monthly intervals
- •Patients with newly diagnosed or established disease, treated with lifestyle modification 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:
- •Fasting plasma glucose (PG) >7.0 mmol/L on 2 or more occasions, and/or
- •Random or 2-hour PG >11.1 mmol/L (after 75 gram oral glucose tolerance test) on 2 or more occasions, and/or
- •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
Incidence of all diabetes-related clinical endpoints
时间窗: 12 months
1. cardiovascular events (acute myocardial infarction, revascularisation procedures, heart failure, unstable angina, arrhythmia, stroke, transient ischemic attacks requiring hospital admissions) 2. chronic kidney disease (eGFR\<60 ml/min/1.73m2) or end stage renal disease (dialysis and/or eGFR\<15 ml/min/1.73m2) 3. visual impairment (corrected visual acuity of 20/200 or worse) or eye surgery 4. lower extremity amputation or foot ulcers requiring hospitalizations 5. major infections - pulmonary and non-pulmonary requiring hospitalizations 6. all-site cancers 7. death
次要结局
- Proportions of patients with improved control of risk factors(12 months)