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

This study has been terminated.
(Due to lack of manpower at the various study sites)
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Wing-Yee So, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00816010
First received: December 30, 2008
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Acute Coronary Syndrome
 Behavioral: telephone contact

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular endpoints [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of hospital admissions, total number of days of hospitalization [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816010

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

No publications provided

Responsible Party: Wing-Yee So, Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00816010     History of Changes
Other Study ID Numbers: Telephone intervention
Study First Received: December 30, 2008
Last Updated: February 20, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
drug compliance
lifestyle modification

Additional relevant MeSH terms:
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013