Coronary Artery Disease
Conditions
Keywords
Intervention, Awareness, Cardiac Rehabilitation (CR), Coronary Artery Patients, Coronary Artery Bypass Grafting Surgery (CABG)
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.
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.
Interventions
BEHAVIORALIncreasing 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.
Sponsors
The Gertner Institute
Israel National Institute for Health Policy and Health Services Research
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Medical Service Utilization | 1 year | Visits to the emergency department during the year following CABG surgery |
| Anthropometric Measures | 1 year | Measurements of body mass index (BMI) |
| Lifestyle Habits (i.e. Smoking) | 1 year | — |
| 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). |
| 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) |
| 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 |
| Blood Pressure | 1 year follow up | The pooled mean of 3 blood pressure measurements taken during the interview |
| Employment Status | 1 year | Number of patients fully employed in each arm |
| 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. |
Countries
Israel
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 504 |
| 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. | 520 |
| Total | 1,024 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 16 | 32 |
| Overall Study | Lost to Follow-up | 76 | 43 |
Baseline characteristics
| Characteristic | Education (Intervention) Regarding Cardiac Rehabilitation (CR) | No Education (Control) Regarding Cardiac Rehabilitation (CR) | Total |
|---|---|---|---|
| Age, Continuous | 65.644 years STANDARD_DEVIATION 9.904 | 66.146 years STANDARD_DEVIATION 10.789 | 65.902 years STANDARD_DEVIATION 10.01 |
| Region of Enrollment Israel | 504 participants | 520 participants | 1024 participants |
| Sex: Female, Male Female | 110 Participants | 134 Participants | 244 Participants |
| Sex: Female, Male Male | 394 Participants | 386 Participants | 780 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 504 | 0 / 523 |
| serious Total, serious adverse events | 114 / 504 | 159 / 523 |
Outcome results
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
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups | 156 participants |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups | 86 participants |
Secondary
MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument.
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
Population: The N for this outcome is the number of patients for whom there are follow-up data after one year.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument. | 5.58 Scores on a scale | Standard Deviation 0.94 |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument. | 5.27 Scores on a scale | Standard Deviation 0.89 |
Other Pre-specified
Anthropometric Measures
Measurements of body mass index (BMI)
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Anthropometric Measures | Body Mass Index (BMI) men | 28.0 kg/m^2 | 95% Confidence Interval 4.4 |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Anthropometric Measures | Body Mass Index (BMI) women | 28.9 kg/m^2 | — |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Anthropometric Measures | Body Mass Index (BMI) men | 27.3 kg/m^2 | 95% Confidence Interval 4.4 |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Anthropometric Measures | Body Mass Index (BMI) women | 28.4 kg/m^2 | — |
Other Pre-specified
Biochemical Markers
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Biochemical Markers | Glucose | 120.4 mg/dl | 95% Confidence Interval 58 |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Biochemical Markers | Total Cholesterol | 164.4 mg/dl | 95% Confidence Interval 38.5 |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Biochemical Markers | Triglycerides | 141.7 mg/dl | — |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Biochemical Markers | LDL Cholesterol | 95.3 mg/dl | — |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Biochemical Markers | LDL Cholesterol | 96.8 mg/dl | — |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Biochemical Markers | Glucose | 123.1 mg/dl | 95% Confidence Interval 64.8 |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Biochemical Markers | Triglycerides | 142.1 mg/dl | — |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Biochemical Markers | Total Cholesterol | 170.6 mg/dl | 95% Confidence Interval 43.5 |
Other Pre-specified
Blood Pressure
The pooled mean of 3 blood pressure measurements taken during the interview
Time frame: 1 year follow up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Blood Pressure | Systolic | 131.9 mm Hg |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Blood Pressure | Diastolic | 74.6 mm Hg |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Blood Pressure | Systolic | 130.8 mm Hg |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Blood Pressure | Diastolic | 74.6 mm Hg |
Other Pre-specified
Cardiovascular Morbidity
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Cardiovascular Morbidity | Acute myocardial infarction (MI) | 61 events |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Cardiovascular Morbidity | Acute, but ill-defined cerebrovascular disease (a | 31 events |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Cardiovascular Morbidity | Angina Pectoris | 6 events |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Cardiovascular Morbidity | Acute myocardial infarction (MI) | 84 events |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Cardiovascular Morbidity | Acute, but ill-defined cerebrovascular disease (a | 35 events |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Cardiovascular Morbidity | Angina Pectoris | 8 events |
Other Pre-specified
Depression & Anxiety
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
Population: All patients who completed the Hospital Anxiety and Depression Scale (HADS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Depression & Anxiety | Anxiety (0=low; 21=high) | 4.66 HADS score | Standard Deviation 4.08 |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Depression & Anxiety | Depression (0=low ; 21=high) | 4.49 HADS score | Standard Deviation 4.32 |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Depression & Anxiety | Anxiety (0=low; 21=high) | 5.33 HADS score | Standard Deviation 4.21 |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Depression & Anxiety | Depression (0=low ; 21=high) | 4.66 HADS score | Standard Deviation 4.09 |
Other Pre-specified
Employment Status
Number of patients fully employed in each arm
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Employment Status | 88 patients |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Employment Status | 82 patients |
Other Pre-specified
Lifestyle Habits (i.e. Smoking)
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Lifestyle Habits (i.e. Smoking) | Current smoker | 38 patients |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Lifestyle Habits (i.e. Smoking) | Past smoker | 208 patients |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Lifestyle Habits (i.e. Smoking) | Never smoked | 157 patients |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Lifestyle Habits (i.e. Smoking) | Current smoker | 46 patients |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Lifestyle Habits (i.e. Smoking) | Past smoker | 215 patients |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Lifestyle Habits (i.e. Smoking) | Never smoked | 167 patients |
Other Pre-specified
Medical Service Utilization
Visits to the emergency department during the year following CABG surgery
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Medical Service Utilization | 78 ER visits |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Medical Service Utilization | 74 ER visits |
Other Pre-specified
Physical Activity
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
Population: All patients who were interviewed 1-year after CABG surgery and responded to the physical activity questionnaire
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Education (Intervention) on Cardiac Rehabilitation (CR) | Physical Activity | Physically active in any sports | 190 patients |
| Education (Intervention) on Cardiac Rehabilitation (CR) | Physical Activity | Sedentary (no sports activities) | 223 patients |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Physical Activity | Physically active in any sports | 162 patients |
| No Education (Control) Regarding Cardiac Rehabilitation (CR) | Physical Activity | Sedentary (no sports activities) | 279 patients |