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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicentre, Randomised Study to Examine the Effects of Telephone Intervention in Patients With Coronary Heart Disease and Diabetes

Conditions
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Type 2 Diabetes Mellitus, Acute Coronary Syndrome

Intervention / Treatment
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* Behavioral: telephone contact


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lifestyle and compliance counseling via telephone contact with structured set of questions and reinforcements provided | Behavioral: telephone contact<br>* for lifestyle and compliance counseling<br>|
| No Intervention: 2<br>Control arm with usual care as per local hospital practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular endpoints |  | 24 months | 
| Number of hospital admissions, total number of days of hospitalization |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug compliance, lifestyle modification