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

May 19, 2011 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Hospital
        • Contact:
          • Tsung-Hsien Lin, MD, PHD
          • Phone Number: 7741 88673121101
          • Email: lth@kmu.edu.tw
        • Principal Investigator:
          • Sheng-Hsiung Sheu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Comparison group
Other: Traditional group
CAD education fryers
Experimental: Integrated health care team
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BP, lipid, glucose, EBM drugs and self-care efficacy
Time Frame: one year
  1. Blood pressure < 140/90 mmHg (< 130/80 mmHg in the diabetics and patients with chronic kidney disease)
  2. Hypercholesterolemia：LDL < 100 mg/dl
  3. Diabetic：HbA1c < 7%
  4. Smoking cessation rate
  5. Adherence rate of EBM medication including anti-platelet agent, beta-blocker, RAS blocker and lipid-lowering agent.
  6. Efficacy of self care
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 990179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stable Angina

Clinical Trials on Traditional group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe