Telephone Intervention in Patients With Acute Coronary Syndrome (ACS) and Diabetes

The Chinese University of Hong Kong

Status

Terminated

Conditions

Acute Coronary Syndrome

Type 2 Diabetes Mellitus

Treatments

Behavioral: telephone contact

Study type

Interventional

Funder types

Other

Identifiers

NCT00816010

Telephone intervention

Details and patient eligibility

About

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.

Full 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 (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.

Enrollment

137 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients admitted to the 5 HA hospitals with principle diagnosis of CHD, age 45 years for male and 55 for female
Presence of diabetes according to the 1998 WHO criteria and no history of unprovoked ketosis and not requiring continuous insulin treatment within 1 year of diagnosis

Exclusion criteria

Patients with terminal malignancy or other life-threatening diseases with less than 3-month expected survival
Telephone contact not available
Patients with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Patients who speak non-Cantonese dialect or different language or have conditions that prevent effective communications e.g. patients who are deaf and mute
Patients who live in nursing home with supervised treatment
Patients who have participated in another intervention study during the last 1 month and who are enrolled in any intervention studies.