Effect of an Educational Intervention on Cardiac Patients' Participation Rate in Cardiac Rehabilitation Programs (MECRIS)

This study has been completed.
Sponsor:
Collaborators:
The Gertner Institute for Epidemiology and Health Policy Research
Israel National Institute for Health Policy and Health Services Research
Information provided by (Responsible Party):
Dr. Rachel Dankner, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00356863
First received: July 25, 2006
Last updated: February 26, 2012
Last verified: January 2012
Results First Received: June 8, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Coronary Artery Disease
Intervention: Behavioral: Increasing awareness to cardiac rehabilitation programs

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All cardiac patients hospitalized in 5 cardiothoracic clinics for coronary artery bypass grafting (CABG) surgery (with or without valve replacement) were offered to participate in the study based on inclusion criteria. Recruitment started on January 2004 and ended on November 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All first 520 recruited participants from the 5 cardiothoracic units belonged to the control arm of the study and received usual care. The following 504 patients recruited in the 5 cardiothoracic units belonged to the intervention arm and received the educational intervention materials of the study regarding cardiac rehabilitation treatment.

Reporting Groups
  Description
Education (Intervention) Regarding Cardiac Rehabilitation (CR) Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
No Education (Control) Regarding Cardiac Rehabilitation (CR) Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.

Participant Flow:   Overall Study
    Education (Intervention) Regarding Cardiac Rehabilitation (CR)     No Education (Control) Regarding Cardiac Rehabilitation (CR)  
STARTED     504     520  
COMPLETED     412     445  
NOT COMPLETED     92     75  
Death                 16                 32  
Lost to Follow-up                 76                 43  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Education (Intervention) Regarding Cardiac Rehabilitation (CR) Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
No Education (Control) Regarding Cardiac Rehabilitation (CR) Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
Total Total of all reporting groups

Baseline Measures
    Education (Intervention) Regarding Cardiac Rehabilitation (CR)     No Education (Control) Regarding Cardiac Rehabilitation (CR)     Total  
Number of Participants  
[units: participants]
  504     520     1024  
Age  
[units: years]
Mean ± Standard Deviation
  65.644  ± 9.904     66.146  ± 10.789     65.902  ± 10.01  
Gender  
[units: participants]
     
Female     110     134     244  
Male     394     386     780  
Region of Enrollment  
[units: participants]
     
Israel     504     520     1024  



  Outcome Measures
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1.  Primary:   Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups   [ Time Frame: 1 year ]

2.  Secondary:   MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument.   [ Time Frame: 1 year ]

3.  Other Pre-specified:   Cardiovascular Morbidity   [ Time Frame: 1 year ]

4.  Other Pre-specified:   Biochemical Markers   [ Time Frame: 1 year ]

5.  Other Pre-specified:   Medical Service Utilization   [ Time Frame: 1 year ]

6.  Other Pre-specified:   Anthropometric Measures   [ Time Frame: 1 year ]

7.  Other Pre-specified:   Lifestyle Habits (i.e. Smoking)   [ Time Frame: 1 year ]

8.  Other Pre-specified:   Employment Status   [ Time Frame: 1 year ]

9.  Other Pre-specified:   Depression & Anxiety   [ Time Frame: 1 year ]

10.  Other Pre-specified:   Physical Activity   [ Time Frame: 1 year ]

11.  Other Pre-specified:   Blood Pressure   [ Time Frame: 1 year follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  1. Lack of randomization
  2. No biochemical tests were performed by the study and information regarding biochemical parameters was drawn from the medical records during baseline and from medical documents during follow up.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rachel S Dankner, MD, MPH
Organization: The Gertner Institute for Epidemiology and Health Service Research
phone: 972-3-5305390
e-mail: RachelD@gertner.health.gov.il


No publications provided by Sheba Medical Center

Publications automatically indexed to this study:

Responsible Party: Dr. Rachel Dankner, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00356863     History of Changes
Other Study ID Numbers: SHEBA-05-2374-RD-CTIL
Study First Received: July 25, 2006
Results First Received: June 8, 2010
Last Updated: February 26, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration