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

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ClinicalTrials.gov Identifier: NCT01357096
Recruitment Status : Unknown
Verified July 2010 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : May 20, 2011
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012

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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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



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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sheng-Hsiung Sheu, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01357096     History of Changes
Other Study ID Numbers: 990179
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: May 20, 2011
Last Verified: July 2010

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Angina, Stable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms