Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multicentre, Randomised Study to Examine the Effects of Telephone Intervention in Patients With Coronary Heart Disease 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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