Ignite Creation Date:
2024-05-05 @ 9:06 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00816010
Status:
TERMINATED
Last Update Posted:
2012-02-22
First Post:
2008-12-30
Brief Title:
Telephone Intervention in Patients With Acute Coronary Syndrome ACS and Diabetes
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Multicentre Randomised Study to Examine the Effects of Telephone Intervention in Patients With Coronary Heart Disease and Diabetes
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to lack of manpower at the various study sites
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 n608 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 n608 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 andor 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
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 n608 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 n608 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None