Development and Efficacy Evaluation of Integrated Chronic Care and Health Promotion Model for Patients With Coronary Artery Disease in Taiwan

Acute Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01357096
• Other study ID #: 990179
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2011
• Last updated: May 19, 2011
• Start date: January 2011

Study information

• Verified date: July 2010
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Sheng-Hsiung Sheu, MD
• Phone: 88673121101
• Email: Sheush[@]kmu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The hypothesis of this project is to examine whether the integrated health care program as the intervention group can reduce the recurrence and mortality of coronary artery-related diseases than the traditional one as the comparison group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

Inclusion Criteria:

• patients who suffered from acute myocardial infarction or stable angina with intervention (CABG or PTCA)

Exclusion Criteria:

1. Age > 85 yrs old.

2. Worse short-term prognosis (e.g.cancer, congestive heart failure NYHA IV)

3. Any systemic disease which will limit the exercise program (e.g. bed-ridden stroke)

4. Unable to participate in the trial due to any logic reasons

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Angina, Stable
• Myocardial Infarction
• Stable Angina

Intervention

Behavioral:
• Integrated health care team
CAD education fryers, drugs counseling, diet intervention, individualized exercise program, body weight control, smoking cessation program, and distant CAD care monitoring

Other:
• Traditional group
CAD education fryers

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death, non-fatal MI, non-fatal stroke, recurrent angina, emergency room (ER) visit due to any CV-related diseases or readmission due to any CV-related diseases confirmed by the physicians.		one year	No
Secondary	BP, lipid, glucose, EBM drugs and self-care efficacy	Blood pressure < 140/90 mmHg (< 130/80 mmHg in the diabetics and patients with chronic kidney disease); Hypercholesterolemia:LDL < 100 mg/dl; Diabetic:HbA1c < 7%; Smoking cessation rate; Adherence rate of EBM medication including anti-platelet agent, beta-blocker, RAS blocker and lipid-lowering agent.; Efficacy of self care	one year	No