Telephone Intervention in Patients With Acute Coronary Syndrome (ACS) and Diabetes
A Multicentre, Randomised Study to Examine the Effects of Telephone Intervention in Patients With Coronary Heart Disease and Diabetes
研究概览
详细说明
Study-design A 2-year multicentre, randomised controlled open study involving 5 HA hospitals in Hong Kong.
Subjects and method One thousand two hundred and sixteen patients admitted to hospital with principle diagnosis of coronary heart disease and known or newly confirmed diabetes on oral glucose tolerance test will be enrolled. Patients in the intervention arm (n=608) will receive telephone intervention between clinic visits by diabetes nurse educator using structured counselling tools with particular emphasis on adherence to lifestyle modification and medications as well as self-monitoring of blood glucose, blood pressure and body weight. Patients in control group (n=608) will not receive telephone intervention. Both groups will be followed up by their usual medical teams in their hospitals upon discharge.
Clinical endpoints Primary endpoint is the composite of death and/or cardiovascular related hospitalisations. Secondary endpoints include hospitalisations due to cardiovascular events, number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Hong Kong、香港
- 5 public hospitals in Hong Kong
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients admitted to the 5 HA hospitals with principle diagnosis of CHD, age 45 years for male and 55 for female
- Presence of diabetes according to the 1998 WHO criteria and no history of unprovoked ketosis and not requiring continuous insulin treatment within 1 year of diagnosis
Exclusion Criteria:
- Patients with terminal malignancy or other life-threatening diseases with less than 3-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
- Patients who speak non-Cantonese dialect or different language or have conditions that prevent effective communications e.g. patients who are deaf and mute
- Patients who live in nursing home with supervised treatment
- Patients who have participated in another intervention study during the last 1 month and who are enrolled in any intervention studies.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
Lifestyle and compliance counseling via telephone contact with structured set of questions and reinforcements provided
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for lifestyle and compliance counseling
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无干预：2
Control arm with usual care as per local hospital practice
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Composite endpoint of death and/or CVD related hospitalisations (acute myocardial infarction, revascularisation procedures, heart failure or unstable angina or arrhythmia requiring hospital admissions, lower extremity amputation and stroke) by 24 months.
大体时间：24 months
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24 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Cardiovascular endpoints
大体时间：24 months
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24 months
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Number of hospital admissions, total number of days of hospitalization
大体时间：24 months
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24 months
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合作者和调查者
调查人员
- 首席研究员：Wing Yee So, MRCP, FRCP、Chinese University of Hong Kong
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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