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

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ClinicalTrials.gov Identifier: NCT00356863
Recruitment Status : Completed
First Posted : July 26, 2006
Results First Posted : March 26, 2012
Last Update Posted : November 20, 2017
Sponsor:
Collaborators:
The Gertner Institute
Israel National Institute for Health Policy and Health Services Research
Information provided by (Responsible Party):
Dr. Rachel Dankner, Sheba Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Coronary Artery Disease
Intervention Behavioral: Increasing awareness to cardiac rehabilitation programs
Enrollment 1024
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.
Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
Hide 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
Reason Not Completed
Death             16             32
Lost to Follow-up             76             43
Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR) Total
Hide 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 Number of Baseline Participants 504 520 1024
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 504 participants 520 participants 1024 participants
65.644  (9.904) 66.146  (10.789) 65.902  (10.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 504 participants 520 participants 1024 participants
Female
110
  21.8%
134
  25.8%
244
  23.8%
Male
394
  78.2%
386
  74.2%
780
  76.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 504 participants 520 participants 1024 participants
504 520 1024
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 450 454
Measure Type: Number
Unit of Measure: participants
156 86
2.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.
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 413 441
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
5.58  (0.94) 5.27  (0.89)
3.Other Pre-specified Outcome
Title Cardiovascular Morbidity
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 413 441
Overall Number of Units Analyzed
Type of Units Analyzed: Hospitalizations
221 292
Measure Type: Number
Unit of Measure: events
Acute myocardial infarction (MI) 61 84
Acute, but ill-defined cerebrovascular disease (a 31 35
Angina Pectoris 6 8
4.Other Pre-specified Outcome
Title Biochemical Markers
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
Hide 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.
Overall Number of Participants Analyzed 413 441
Mean (95% Confidence Interval)
Unit of Measure: mg/dl
Glucose
120.4
(115.9 to 124.8)
123.1
(118.3 to 128.0)
Total Cholesterol
164.4
(160.0 to 168.7)
170.6
(165.8 to 175.4)
Triglycerides
141.7
(134.0 to 149.4)
142.1
(133.6 to 150.6)
LDL Cholesterol
95.3
(91.5 to 99.1)
96.8
(92.8 to 100.8)
5.Other Pre-specified Outcome
Title Medical Service Utilization
Hide Description Visits to the emergency department during the year following CABG surgery
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
Hide 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.
Overall Number of Participants Analyzed 413 441
Measure Type: Number
Unit of Measure: ER visits
78 74
6.Other Pre-specified Outcome
Title Anthropometric Measures
Hide Description Measurements of body mass index (BMI)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
Hide 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.
Overall Number of Participants Analyzed 413 441
Mean (95% Confidence Interval)
Unit of Measure: kg/m^2
Body Mass Index (BMI) men
28.0
(27.6 to 28.4)
27.3
(26.9 to 27.7)
Body Mass Index (BMI) women
28.9
(27.9 to 30.0)
28.4
(27.6 to 29.3)
7.Other Pre-specified Outcome
Title Lifestyle Habits (i.e. Smoking)
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
Hide 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.
Overall Number of Participants Analyzed 413 441
Measure Type: Number
Unit of Measure: patients
Current smoker 38 46
Past smoker 208 215
Never smoked 157 167
8.Other Pre-specified Outcome
Title Employment Status
Hide Description Number of patients fully employed in each arm
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
Hide 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.
Overall Number of Participants Analyzed 413 441
Measure Type: Number
Unit of Measure: patients
88 82
9.Other Pre-specified Outcome
Title Depression & Anxiety
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 413 441
Mean (Standard Deviation)
Unit of Measure: HADS score
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)
10.Other Pre-specified Outcome
Title Physical Activity
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 413 441
Measure Type: Number
Unit of Measure: patients
Physically active in any sports 190 162
Sedentary (no sports activities) 223 279
11.Other Pre-specified Outcome
Title Blood Pressure
Hide Description The pooled mean of 3 blood pressure measurements taken during the interview
Time Frame 1 year follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
Hide 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.
Overall Number of Participants Analyzed 450 454
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
Systolic
131.9
(130.1 to 133.7)
130.8
(129.1 to 132.5)
Diastolic
74.6
(73.8 to 75.5)
74.6
(73.8 to 75.4)
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)
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide 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 (22.62%)      159/523 (30.40%)    
Cardiac disorders     
Death  1 [1]  16/504 (3.17%)  16 32/523 (6.12%)  32
acute myocardial infarction, unspecified site  2  61/504 (12.10%)  61 84/523 (16.06%)  84
other and unspecified angina pectoris  4  6/504 (1.19%)  6 8/523 (1.53%)  8
Vascular disorders     
acute, but ill-defined cerebrovascular disease (apoplexy, n.o.s)/transient cerebral ischemia  3  31/504 (6.15%)  31 35/523 (6.69%)  35
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD-9
2
Term from vocabulary, 410.9
3
Term from vocabulary, 436, 435
4
Term from vocabulary, 413.9
[1]
Total mortality
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Education (Intervention) Regarding Cardiac Rehabilitation (CR) No Education (Control) Regarding Cardiac Rehabilitation (CR)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/504 (0.00%)      0/523 (0.00%)    
  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.
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
Responsible Party: Dr. Rachel Dankner, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00356863     History of Changes
Other Study ID Numbers: SHEBA-05-2374-RD-CTIL
First Submitted: July 25, 2006
First Posted: July 26, 2006
Results First Submitted: June 8, 2010
Results First Posted: March 26, 2012
Last Update Posted: November 20, 2017