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

Primary Purpose

Acute Myocardial Infarction, Stable Angina

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Integrated health care team
Traditional group
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Myocardial Infarction focused on measuring intervention, CABG or PTCA

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Comparison group

Integrated health care team

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2011
Last Updated
May 19, 2011
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01357096
Brief Title
Development and Efficacy Evaluation of Integrated Chronic Care and Health Promotion Model for Patients With Coronary Artery Disease in Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Stable Angina
Keywords
intervention, CABG or PTCA

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparison group
Arm Type
No Intervention
Arm Title
Integrated health care team
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Integrated health care team
Intervention Description
CAD education fryers, drugs counseling, diet intervention, individualized exercise program, body weight control, smoking cessation program, and distant CAD care monitoring
Intervention Type
Other
Intervention Name(s)
Traditional group
Intervention Description
CAD education fryers
Primary Outcome Measure Information:
Title
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
BP, lipid, glucose, EBM drugs and self-care efficacy
Description
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
Time Frame
one year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who suffered from acute myocardial infarction or stable angina with intervention (CABG or PTCA) Exclusion Criteria: Age > 85 yrs old. Worse short-term prognosis (e.g.cancer, congestive heart failure NYHA IV) Any systemic disease which will limit the exercise program (e.g. bed-ridden stroke) Unable to participate in the trial due to any logic reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Hsiung Sheu, MD
Phone
88673121101
Ext
7741
Email
Sheush@kmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Tsung-Hsien Lin, MD. PHD
Phone
88673121101
Ext
7741
Email
lth@kmu.edu.tw
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsung-Hsien Lin, MD, PHD
Phone
88673121101
Ext
7741
Email
lth@kmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Sheng-Hsiung Sheu, MD

12. IPD Sharing Statement

Learn more about this trial

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

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