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

Sponsor
Sheba Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00356863
Collaborator
The Gertner Institute (Other), Israel National Institute for Health Policy and Health Services Research (Other)
1,024
1
2
70
14.6

Study Details

Study Description

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
  • Behavioral: Increasing awareness to cardiac rehabilitation programs
N/A

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.

Study Design

Study Type:
Interventional
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 :
Feb 1, 2004
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    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 [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. [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 [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 [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 [1 year]

      Visits to the emergency department during the year following CABG surgery

    4. Anthropometric Measures [1 year]

      Measurements of body mass index (BMI)

    5. Lifestyle Habits (i.e. Smoking) [1 year]

    6. Employment Status [1 year]

      Number of patients fully employed in each arm

    7. Depression & Anxiety [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 [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 [1 year follow up]

      The pooled mean of 3 blood pressure measurements taken during the interview

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Investigators

    • Principal Investigator: Rachel Dankner, MD MPH, The Gertner Institute for Epidemiology and Health Service Research, Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Dr. Rachel Dankner, Senior investigator, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT00356863
    Other Study ID Numbers:
    • SHEBA-05-2374-RD-CTIL
    First Posted:
    Jul 26, 2006
    Last Update Posted:
    Nov 20, 2017
    Last Verified:
    Oct 1, 2017
    Keywords provided by Dr. Rachel Dankner, Senior investigator, Sheba Medical Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details 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 Detail 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.
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Period Title: Overall Study
    STARTED 504 520
    COMPLETED 412 445
    NOT COMPLETED 92 75

    Baseline Characteristics

    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR) Total
    Arm/Group Description 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. 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 of all reporting groups
    Overall Participants 504 520 1024
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65.644
    (9.904)
    66.146
    (10.789)
    65.902
    (10.01)
    Sex: Female, Male (Count of Participants)
    Female
    110
    21.8%
    134
    25.8%
    244
    23.8%
    Male
    394
    78.2%
    386
    74.2%
    780
    76.2%
    Region of Enrollment (participants) [Number]
    Israel
    504
    100%
    520
    100%
    1024
    100%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    All patients alive at 1-year follow up who gave information on participation in cardiac rehabilitation programs (CRPs) at any time during the year following surgery (and before follow up assessment). This information was obtained via a face-to-face interview or by telephone interview.
    Arm/Group Title Education (Intervention) on Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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 CR and were giving the usual care.
    Measure Participants 450 454
    Number [participants]
    156
    31%
    86
    16.5%
    2. Other Pre-specified Outcome
    Title Cardiovascular Morbidity
    Description 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).
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    All patients who were exposed to the educational intervention at baseline and who were contacted a year later and gave information regarding participation in cardiac rehabilitation during the follow up year.
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 413 441
    Measure hospitalizations 221 292
    Acute myocardial infarction (MI)
    61
    84
    Acute, but ill-defined cerebrovascular disease (a
    31
    35
    Angina Pectoris
    6
    8
    3. Other Pre-specified Outcome
    Title Biochemical Markers
    Description 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.
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 413 441
    Glucose
    120.4
    (58.0)
    123.1
    (64.8)
    Total Cholesterol
    164.4
    (38.5)
    170.6
    (43.5)
    Triglycerides
    141.7
    142.1
    LDL Cholesterol
    95.3
    96.8
    4. Other Pre-specified Outcome
    Title Medical Service Utilization
    Description Visits to the emergency department during the year following CABG surgery
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 413 441
    Number [ER visits]
    78
    74
    5. Other Pre-specified Outcome
    Title Anthropometric Measures
    Description Measurements of body mass index (BMI)
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 413 441
    Body Mass Index (BMI) men
    28.0
    (4.4)
    27.3
    (4.4)
    Body Mass Index (BMI) women
    28.9
    28.4
    6. Other Pre-specified Outcome
    Title Lifestyle Habits (i.e. Smoking)
    Description
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 413 441
    Current smoker
    38
    46
    Past smoker
    208
    215
    Never smoked
    157
    167
    7. Other Pre-specified Outcome
    Title Employment Status
    Description Number of patients fully employed in each arm
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 413 441
    Number [patients]
    88
    82
    8. Other Pre-specified Outcome
    Title Depression & Anxiety
    Description 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)
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    All patients who completed the Hospital Anxiety and Depression Scale (HADS)
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 413 441
    Anxiety (0=low; 21=high)
    4.66
    (4.08)
    5.33
    (4.21)
    Depression (0=low ; 21=high)
    4.49
    (4.32)
    4.66
    (4.09)
    9. Other Pre-specified Outcome
    Title Physical Activity
    Description 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
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    All patients who were interviewed 1-year after CABG surgery and responded to the physical activity questionnaire
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 413 441
    Physically active in any sports
    190
    162
    Sedentary (no sports activities)
    223
    279
    10. Secondary Outcome
    Title MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument.
    Description 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.
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    The N for this outcome is the number of patients for whom there are follow-up data after one year.
    Arm/Group Title Educational (Intervention) on Cardiac Rehabilitation (CR) No Education (Control) About Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 413 441
    Mean (Standard Deviation) [Scores on a scale]
    5.58
    (0.94)
    5.27
    (0.89)
    11. Other Pre-specified Outcome
    Title Blood Pressure
    Description The pooled mean of 3 blood pressure measurements taken during the interview
    Time Frame 1 year follow up

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    Measure Participants 450 454
    Systolic
    131.9
    130.8
    Diastolic
    74.6
    74.6

    Adverse Events

    Time Frame 1-year follow up after baseline interview.
    Adverse Event Reporting Description Baseline interview was conducted during hospitalization period before CABG surgery.
    Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Arm/Group Description 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. 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.
    All Cause Mortality
    Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 114/504 (22.6%) 159/523 (30.4%)
    Cardiac disorders
    Death 16/504 (3.2%) 16 32/523 (6.1%) 32
    acute myocardial infarction, unspecified site 61/504 (12.1%) 61 84/523 (16.1%) 84
    other and unspecified angina pectoris 6/504 (1.2%) 6 8/523 (1.5%) 8
    Vascular disorders
    acute, but ill-defined cerebrovascular disease (apoplexy, n.o.s)/transient cerebral ischemia 31/504 (6.2%) 31 35/523 (6.7%) 35
    Other (Not Including Serious) Adverse Events
    Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/504 (0%) 0/523 (0%)

    Limitations/Caveats

    Lack of randomization 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

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    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
    Email RachelD@gertner.health.gov.il
    Responsible Party:
    Dr. Rachel Dankner, Senior investigator, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT00356863
    Other Study ID Numbers:
    • SHEBA-05-2374-RD-CTIL
    First Posted:
    Jul 26, 2006
    Last Update Posted:
    Nov 20, 2017
    Last Verified:
    Oct 1, 2017