Trial Outcomes & Findings for Effect of an Educational Intervention on Cardiac Patients' Participation Rate in Cardiac Rehabilitation Programs (NCT NCT00356863)
NCT ID: NCT00356863
Last Updated: 2017-11-20
Results Overview
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.
COMPLETED
NA
1024 participants
1 year
2017-11-20
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
504
|
520
|
|
Overall Study
COMPLETED
|
412
|
445
|
|
Overall Study
NOT COMPLETED
|
92
|
75
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
16
|
32
|
|
Overall Study
Lost to Follow-up
|
76
|
43
|
Baseline Characteristics
Effect of an Educational Intervention on Cardiac Patients' Participation Rate in Cardiac Rehabilitation Programs
Baseline characteristics by cohort
| Measure |
Education (Intervention) Regarding Cardiac Rehabilitation (CR)
n=504 Participants
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)
n=520 Participants
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
n=1024 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.644 years
STANDARD_DEVIATION 9.904 • n=5 Participants
|
66.146 years
STANDARD_DEVIATION 10.789 • n=7 Participants
|
65.902 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
394 Participants
n=5 Participants
|
386 Participants
n=7 Participants
|
780 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
504 participants
n=5 Participants
|
520 participants
n=7 Participants
|
1024 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=450 Participants
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)
n=454 Participants
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.
|
|---|---|---|
|
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
|
86 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The N for this outcome is the number of patients for whom there are follow-up data after one 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.
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=413 Participants
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)
n=441 Participants
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.
|
|---|---|---|
|
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
|
5.27 Scores on a scale
Standard Deviation 0.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: 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.
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).
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=221 hospitalizations
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)
n=292 hospitalizations
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.
|
|---|---|---|
|
Cardiovascular Morbidity
Acute myocardial infarction (MI)
|
61 events
|
84 events
|
|
Cardiovascular Morbidity
Acute, but ill-defined cerebrovascular disease (a
|
31 events
|
35 events
|
|
Cardiovascular Morbidity
Angina Pectoris
|
6 events
|
8 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearglucose, 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.
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=413 Participants
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)
n=441 Participants
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.
|
|---|---|---|
|
Biochemical Markers
Glucose
|
120.4 mg/dl
95% Confidence Interval 58.0 • Interval 115.9 to 124.8
|
123.1 mg/dl
95% Confidence Interval 64.8 • Interval 118.3 to 128.0
|
|
Biochemical Markers
Total Cholesterol
|
164.4 mg/dl
95% Confidence Interval 38.5 • Interval 160.0 to 168.7
|
170.6 mg/dl
95% Confidence Interval 43.5 • Interval 165.8 to 175.4
|
|
Biochemical Markers
Triglycerides
|
141.7 mg/dl
Interval 134.0 to 149.4
|
142.1 mg/dl
Interval 133.6 to 150.6
|
|
Biochemical Markers
LDL Cholesterol
|
95.3 mg/dl
Interval 91.5 to 99.1
|
96.8 mg/dl
Interval 92.8 to 100.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearVisits to the emergency department during the year following CABG surgery
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=413 Participants
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)
n=441 Participants
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.
|
|---|---|---|
|
Medical Service Utilization
|
78 ER visits
|
74 ER visits
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearMeasurements of body mass index (BMI)
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=413 Participants
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)
n=441 Participants
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.
|
|---|---|---|
|
Anthropometric Measures
Body Mass Index (BMI) men
|
28.0 kg/m^2
95% Confidence Interval 4.4 • Interval 27.6 to 28.4
|
27.3 kg/m^2
95% Confidence Interval 4.4 • Interval 26.9 to 27.7
|
|
Anthropometric Measures
Body Mass Index (BMI) women
|
28.9 kg/m^2
Interval 27.9 to 30.0
|
28.4 kg/m^2
Interval 27.6 to 29.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=413 Participants
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)
n=441 Participants
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.
|
|---|---|---|
|
Lifestyle Habits (i.e. Smoking)
Current smoker
|
38 patients
|
46 patients
|
|
Lifestyle Habits (i.e. Smoking)
Past smoker
|
208 patients
|
215 patients
|
|
Lifestyle Habits (i.e. Smoking)
Never smoked
|
157 patients
|
167 patients
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearNumber of patients fully employed in each arm
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=413 Participants
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)
n=441 Participants
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.
|
|---|---|---|
|
Employment Status
|
88 patients
|
82 patients
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: All patients who completed the Hospital Anxiety and Depression Scale (HADS)
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)
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=413 Participants
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)
n=441 Participants
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.
|
|---|---|---|
|
Depression & Anxiety
Anxiety (0=low; 21=high)
|
4.66 HADS score
Standard Deviation 4.08
|
5.33 HADS score
Standard Deviation 4.21
|
|
Depression & Anxiety
Depression (0=low ; 21=high)
|
4.49 HADS score
Standard Deviation 4.32
|
4.66 HADS score
Standard Deviation 4.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: All patients who were interviewed 1-year after CABG surgery and responded to the physical activity questionnaire
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
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=413 Participants
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)
n=441 Participants
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.
|
|---|---|---|
|
Physical Activity
Physically active in any sports
|
190 patients
|
162 patients
|
|
Physical Activity
Sedentary (no sports activities)
|
223 patients
|
279 patients
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 year follow upThe pooled mean of 3 blood pressure measurements taken during the interview
Outcome measures
| Measure |
Education (Intervention) on Cardiac Rehabilitation (CR)
n=450 Participants
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)
n=454 Participants
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.
|
|---|---|---|
|
Blood Pressure
Systolic
|
131.9 mm Hg
Interval 130.1 to 133.7
|
130.8 mm Hg
Interval 129.1 to 132.5
|
|
Blood Pressure
Diastolic
|
74.6 mm Hg
Interval 73.8 to 75.5
|
74.6 mm Hg
Interval 73.8 to 75.4
|
Adverse Events
Education (Intervention) Regarding Cardiac Rehabilitation (CR)
No Education (Control) Regarding Cardiac Rehabilitation (CR)
Serious adverse events
| Measure |
Education (Intervention) Regarding Cardiac Rehabilitation (CR)
n=504 participants at risk
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)
n=523 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Death
|
3.2%
16/504 • Number of events 16 • 1-year follow up after baseline interview.
Baseline interview was conducted during hospitalization period before CABG surgery.
|
6.1%
32/523 • Number of events 32 • 1-year follow up after baseline interview.
Baseline interview was conducted during hospitalization period before CABG surgery.
|
|
Cardiac disorders
acute myocardial infarction, unspecified site
|
12.1%
61/504 • Number of events 61 • 1-year follow up after baseline interview.
Baseline interview was conducted during hospitalization period before CABG surgery.
|
16.1%
84/523 • Number of events 84 • 1-year follow up after baseline interview.
Baseline interview was conducted during hospitalization period before CABG surgery.
|
|
Vascular disorders
acute, but ill-defined cerebrovascular disease (apoplexy, n.o.s)/transient cerebral ischemia
|
6.2%
31/504 • Number of events 31 • 1-year follow up after baseline interview.
Baseline interview was conducted during hospitalization period before CABG surgery.
|
6.7%
35/523 • Number of events 35 • 1-year follow up after baseline interview.
Baseline interview was conducted during hospitalization period before CABG surgery.
|
|
Cardiac disorders
other and unspecified angina pectoris
|
1.2%
6/504 • Number of events 6 • 1-year follow up after baseline interview.
Baseline interview was conducted during hospitalization period before CABG surgery.
|
1.5%
8/523 • Number of events 8 • 1-year follow up after baseline interview.
Baseline interview was conducted during hospitalization period before CABG surgery.
|
Other adverse events
Adverse event data not reported
Additional Information
Rachel S Dankner, MD, MPH
The Gertner Institute for Epidemiology and Health Service Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place