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Due to lack of manpower at the various study sites
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| Name | Class |
|---|---|
| Hospital Authority, Hong Kong | OTHER_GOV |
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Hypothesis To investigate whether telephone counselling by nurse educator between clinic visits with particular emphasis on adherence to medications and lifestyle modification in patients with coronary heart disease and diabetes will reduce mortality and hospitalisation rates due to cardiovascular events compared to usual clinic-based care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lifestyle and compliance counseling via telephone contact with structured set of questions and reinforcements provided |
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| 2 | No Intervention | Control arm with usual care as per local hospital practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telephone contact | Behavioral | for lifestyle and compliance counseling |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular endpoints | 24 months | |
| Number of hospital admissions, total number of days of hospitalization | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wing Yee So, MRCP, FRCP | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 5 public hospitals in Hong Kong | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D054058 | Acute Coronary Syndrome |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |