NCT01357096

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Last Updated

May 20, 2011

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

May 18, 2011

Last Update Submit

May 19, 2011

Conditions

Keywords

interventionCABG or PTCA

Outcome Measures

Primary Outcomes (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.

    one year

Secondary Outcomes (1)

  • BP, lipid, glucose, EBM drugs and self-care efficacy

    one year

Study Arms (2)

Comparison group

NO INTERVENTION
Other: Traditional group

Integrated health care team

EXPERIMENTAL
Behavioral: Integrated health care team

Interventions

CAD education fryers, drugs counseling, diet intervention, individualized exercise program, body weight control, smoking cessation program, and distant CAD care monitoring

Integrated health care team

CAD education fryers

Comparison group

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung, Taiwan, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Sheng-Hsiung Sheu, MD

CONTACT

Tsung-Hsien Lin, MD. PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 20, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Last Updated

May 20, 2011

Record last verified: 2010-07

Locations