Telephone Intervention in Patients With Acute Coronary Syndrome (ACS) and Diabetes
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.
Type 2 Diabetes Mellitus
Acute Coronary Syndrome
Behavioral: telephone contact
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Multicentre, Randomised Study to Examine the Effects of Telephone Intervention in Patients With Coronary Heart Disease and Diabetes|
- 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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Cardiovascular endpoints [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Number of hospital admissions, total number of days of hospitalization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Lifestyle and compliance counseling via telephone contact with structured set of questions and reinforcements provided
Behavioral: telephone contact
for lifestyle and compliance counseling
No Intervention: 2
Control arm with usual care as per local hospital practice
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.
|5 public hospitals in Hong Kong|
|Hong Kong, Hong Kong|
|Principal Investigator:||Wing Yee So, MRCP, FRCP||Chinese University of Hong Kong|