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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00356863
Recruitment Status : Completed
First Posted : July 26, 2006
Results First Posted : March 26, 2012
Last Update Posted : November 20, 2017
The Gertner Institute
Israel National Institute for Health Policy and Health Services Research
Information provided by (Responsible Party):
Dr. Rachel Dankner, Sheba Medical Center

Brief Summary:
The main aim of the study is to determine the effectiveness of an educational intervention designed to increase attendance of coronary artery bypass grafting (CABG) patients at Cardiac Rehabilitation Programs (CRPs) on actual CRP participation rate and; examine patient-related factors (demographic, health, psychosocial, awareness) influencing patients' attendance at CRPs. We hypothesized that the proportion of CABG patients participating in CRPs will increase significantly to 20-30% following the educational intervention employed.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Behavioral: Increasing awareness to cardiac rehabilitation programs Not Applicable

Detailed Description:

Coronary heart disease (CHD) is a major cause of disability and economic burden in western societies. Ample evidence exists to suggest that participation of these patients in structured Cardiac Rehabilitation Programs (CRPs) is beneficial in terms of improved prognosis and quality of life. Despite inclusion of cardiac rehabilitation (CR) in the Medical Insurance Basket (MIB) as a treatment for patients after an acute myocardial infarction (MI), for those after coronary artery bypass grafting (CABG), and more recently for patients suffering from congestive heart failure, only a small proportion (5%-7.5%) of patients take part in CRPs in Israel. Several factors have been identified as barriers to CRP in Israel, two of which are lack of patients motivation to participate in CRPs stemming, in part, from lack of awareness regarding the importance of CR and its availability and; Lack of motivation of medical staff to refer patients to CR resulting from a unawareness of the importance of CR and its availability across Israel, to name a few. The present study accords with such recommendations, by proposing a simple intervention designed to improve patients' and medical staff's awareness to the importance of CR participation. It is expected that CRP participation will significantly increase to 20-30% following the educational intervention employed.

This intervention will provide the basis for the implementation of an intervention to increase CRP participation in cardiac patients at a national level.

In addition to increasing the proportion of CABG patients attending at CRPs, the study aims to measure the effect of CRP participation on subsequent 1-year health and behavior related outcomes, and 3-year mortality. We expect to find differences in outcome measures between participating patients and those who do not.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1024 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Influence of Increasing Awareness of Cardiac Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery to Cardiac Rehabilitation (CR) on Actual Participation Rates and; Patients' Related Barriers to CR Programs Participation
Study Start Date : February 2004
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Explanation on cardiac rehabilitation
Intervention: Increasing awareness to cardiac rehabilitation programs: Patients received a written and oral short explanation on the importance and benefits of cardiac rehabilitation (CR) participation, and information on available programs. They were telephoned 2 weeks after hospital discharge to encourage them to enroll at a cardiac rehabilitation program (CRP). In addition, physicians and nurses at the cardiothoracic units participated in a 1-hour seminar on CR. A recommendation to the general physician to refer the patient to CRP was added to the letter of discharge from hospital.
Behavioral: Increasing awareness to cardiac rehabilitation programs
Increasing awareness to cardiac rehabilitation programs: Before coronary artery bypass grafting (CABG) surgery patients received a face-to-face explanation on their right to participate in cardiac rehabilitation programs (CRPs) under the Israeli Basket of Health Services; they were also provided with a brochure on the benefits of CRP participation and the availability of CRPs throughout the country.
Other Name: Improving participation at cardiac rehabilitation programs

No Intervention: Usual care with no intervention
Patients recruited to the study received the usual care without any additional explanation on cardiac rehabilitation, and no effort to increase their awareness or the ward's awareness to cardiac rehabilitation was done.

Primary Outcome Measures :
  1. 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 ]
    The number of cardiac patients who participated in cardiac rehabilitation programs during the year following coronary artery bypass grafting surgery in the control and the intervention groups.

Secondary Outcome Measures :
  1. 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 ]
    MacNew questionnaire (MACNEW). A self-administered heart disease-specific health-related quality of life (HRQL) instrument. The MacNew is a modification of the original interviewer-administered Quality of Life after Myocardial Infarction [QLMI] instrument. It addresses three major HRQL domains, the Emotional, Physical, and Social domains which can be combined to give a Global HRQL score. The MacNew consists of 27 items. The total mean score ranges between 1 and 7, where higher score means better HRQL.

Other Outcome Measures:
  1. Cardiovascular Morbidity [ Time Frame: 1 year ]
    All hospitalizations which occured during the 1 year follow-up and were due to acute myocardial infarction (International Classification of Disease 9th version (ICD-9) codes 410.), angina pectoris (ICD-9 codes 413.9), stroke/ transient ischemic attack (TIA) (ICD-9 codes 436.), and all surgical procedures which occured during the 1 year follow-up: CABG or coronary catheterizations (ICD-9 codes 36.), endarterectomies (ICD-9 codes 38.0 and 39.0).

  2. Biochemical Markers [ Time Frame: 1 year ]
    glucose, total cholesterol, triglycerides, low density lipoprotein (LDL) cholesterol. Data regarding these biochemical markers was collected from medical available documents at the homes of the patients. In many cases this data was unavailable. Reported values are only available for a subpopulation.

  3. Medical Service Utilization [ Time Frame: 1 year ]
    Visits to the emergency department during the year following CABG surgery

  4. Anthropometric Measures [ Time Frame: 1 year ]
    Measurements of body mass index (BMI)

  5. Lifestyle Habits (i.e. Smoking) [ Time Frame: 1 year ]
  6. Employment Status [ Time Frame: 1 year ]
    Number of patients fully employed in each arm

  7. Depression & Anxiety [ Time Frame: 1 year ]
    Score in the HADS (hospital Anxiety and Depression Scale) screening for anxiety and depression. This is a 14 item scale, 7 items for anxiety and 7 items for depression. Each item can score 0-3 (0=good, 3=bad) and the total score for each scale varies between 0 (no depression/anxiety) to 21 (clinical depression/anxiety requiring medical intervention)

  8. Physical Activity [ Time Frame: 1 year ]
    Self-reported physical activity using a physical activity questionnaire validated in Hebrew. Details of the study validating the instrument: "Development of a Hebrew questionnaire to be used in epidemiological studies to assess physical fitness--validation against sub maximal stress test and predicted VO2max". Ken-Dror G, Lerman Y, Segev S, Dankner R. Harefuah. 2004 Aug;143(8):566-72, 623. Hebrew. PMID: 15523807 VO2max=maximal oxygen uptake

  9. Blood Pressure [ Time Frame: 1 year follow up ]
    The pooled mean of 3 blood pressure measurements taken during the interview

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing Coronary Artery Bypass Grafting with or without valve replacement

Exclusion Criteria:

  • Institutionalized patients
  • Patients with severe co-morbidities for whom cardiac rehabilitation (CR) is contra-indicated
  • Patients who sustained a severe surgical complication preventing them from participating in CR (general stroke with severe disability)
  • Patients residing farther than 30 km from a rehabilitation center

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 identifier (NCT number): NCT00356863

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Sheba Medical Center, the Gertner institute for epidemiology and health service research
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
The Gertner Institute
Israel National Institute for Health Policy and Health Services Research
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Principal Investigator: Rachel Dankner, MD MPH The Gertner Institute for Epidemiology and Health Service Research, Sheba Medical Center

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Rachel Dankner, Senior investigator, Sheba Medical Center Identifier: NCT00356863     History of Changes
Other Study ID Numbers: SHEBA-05-2374-RD-CTIL
First Posted: July 26, 2006    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: November 20, 2017
Last Verified: October 2017

Keywords provided by Dr. Rachel Dankner, Sheba Medical Center:
Cardiac Rehabilitation (CR)
Coronary Artery Patients
Coronary Artery Bypass Grafting Surgery (CABG)

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases