Telephone Intervention in Patients With Acute Coronary Syndrome (ACS) and Diabetes
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|ClinicalTrials.gov Identifier: NCT00816010|
Recruitment Status : Terminated (Due to lack of manpower at the various study sites)
First Posted : December 31, 2008
Last Update Posted : February 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Acute Coronary Syndrome||Behavioral: telephone contact||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
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
- 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 ]
- Cardiovascular endpoints [ Time Frame: 24 months ]
- Number of hospital admissions, total number of days of hospitalization [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816010
|5 public hospitals in Hong Kong|
|Hong Kong, Hong Kong|
|Principal Investigator:||Wing Yee So, MRCP, FRCP||Chinese University of Hong Kong|