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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01357096
First received: May 18, 2011
Last updated: May 19, 2011
Last verified: July 2010
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Stable Angina
Behavioral: Integrated health care team
Other: Traditional group

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

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BP, lipid, glucose, EBM drugs and self-care efficacy [ Time Frame: one year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 400
Study Start Date: January 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357096

Contacts
Contact: Sheng-Hsiung Sheu, MD 88673121101 ext 7741 Sheush@kmu.edu.tw
Contact: Tsung-Hsien Lin, MD. PHD 88673121101 ext 7741 lth@kmu.edu.tw

Locations
Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Tsung-Hsien Lin, MD, PHD    88673121101 ext 7741    lth@kmu.edu.tw   
Principal Investigator: Sheng-Hsiung Sheu, MD         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
  More Information

No publications provided

Responsible Party: Sheng-Hsiung Sheu, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01357096     History of Changes
Other Study ID Numbers: 990179
Study First Received: May 18, 2011
Last Updated: May 19, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
intervention
CABG or PTCA

Additional relevant MeSH terms:
Angina, Stable
Coronary Artery Disease
Infarction
Myocardial Infarction
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Coronary Disease
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014