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

NCT00816010 | Terminated

• 1 other identifier: Telephone intervention
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Acute Coronary Syndrome

Keywords

drug compliance; lifestyle modification

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (2)

• Cardiovascular endpoints

  24 months

• Number of hospital admissions, total number of days of hospitalization

  24 months

Study Arms (2)

1

EXPERIMENTAL

Lifestyle and compliance counseling via telephone contact with structured set of questions and reinforcements provided

Behavioral: telephone contact

2

NO INTERVENTION

Control arm with usual care as per local hospital practice

Interventions

telephone contact BEHAVIORAL

for lifestyle and compliance counseling

1

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

5 public hospitals in Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Acute Coronary Syndrome; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Wing Yee So, MRCP, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: December 30, 2008
• First Posted: December 31, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

HK (1)