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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Wing-Yee So, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Acute Coronary Syndrome Behavioral: telephone contact Not Applicable

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 (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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Cardiovascular endpoints [ Time Frame: 24 months ]
  2. Number of hospital admissions, total number of days of hospitalization [ Time Frame: 24 months ]

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00816010

Hong Kong
5 public hospitals in Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Hospital Authority, Hong Kong
Principal Investigator: Wing Yee So, MRCP, FRCP Chinese University of Hong Kong

Responsible Party: Wing-Yee So, Consultant, Chinese University of Hong Kong Identifier: NCT00816010     History of Changes
Other Study ID Numbers: Telephone intervention
First Posted: December 31, 2008    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Wing-Yee So, Chinese University of Hong Kong:
drug compliance
lifestyle modification

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Acute Coronary Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases