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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00816010
• Other study ID #: Telephone intervention
• Status: Terminated
• Phase: N/A
• First received: December 30, 2008
• Last updated: February 20, 2012
• Start date: July 2008
• Est. completion date: November 2010

Study information

• Verified date: February 2012
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 137
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• telephone contact
for lifestyle and compliance counseling

Locations

Country	Name	City	State
Hong Kong	5 public hospitals in Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cardiovascular endpoints		24 months	No
Secondary	Number of hospital admissions, total number of days of hospitalization		24 months	No