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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Increasing awareness to cardiac rehabilitation programs
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Intervention, Awareness, Cardiac Rehabilitation (CR), Coronary Artery Patients, Coronary Artery Bypass Grafting Surgery (CABG)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheba Medical Center, the Gertner institute for epidemiology and health service research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Explanation on cardiac rehabilitation

Usual care with no intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 25, 2006
Last Updated
October 17, 2017
Sponsor
Sheba Medical Center
Collaborators
The Gertner Institute, Israel National Institute for Health Policy and Health Services Research
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1. Study Identification

Unique Protocol Identification Number
NCT00356863
Brief Title
Effect of an Educational Intervention on Cardiac Patients' Participation Rate in Cardiac Rehabilitation Programs
Acronym
MECRIS
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 Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
The Gertner Institute, Israel National Institute for Health Policy and Health Services Research

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Intervention, Awareness, Cardiac Rehabilitation (CR), Coronary Artery Patients, Coronary Artery Bypass Grafting Surgery (CABG)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1024 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Explanation on cardiac rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care with no intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Increasing awareness to cardiac rehabilitation programs
Other Intervention Name(s)
Improving participation at cardiac rehabilitation programs
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
Other Pre-specified Outcome Measures:
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
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
Title
Medical Service Utilization
Description
Visits to the emergency department during the year following CABG surgery
Time Frame
1 year
Title
Anthropometric Measures
Description
Measurements of body mass index (BMI)
Time Frame
1 year
Title
Lifestyle Habits (i.e. Smoking)
Time Frame
1 year
Title
Employment Status
Description
Number of patients fully employed in each arm
Time Frame
1 year
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
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
Title
Blood Pressure
Description
The pooled mean of 3 blood pressure measurements taken during the interview
Time Frame
1 year follow up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Dankner, MD MPH
Organizational Affiliation
The Gertner Institute for Epidemiology and Health Service Research, Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center, the Gertner institute for epidemiology and health service research
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
25183694
Citation
Dankner R, Drory Y, Geulayov G, Ziv A, Novikov I, Zlotnick AY, Moshkovitz Y, Elami A, Schwammenthal E, Goldbourt U. A controlled intervention to increase participation in cardiac rehabilitation. Eur J Prev Cardiol. 2015 Sep;22(9):1121-8. doi: 10.1177/2047487314548815. Epub 2014 Sep 2.
Results Reference
background
PubMed Identifier
23367742
Citation
Gendler Y, Geulayov G, Ziv A, Novikov I, Dankner R; Multi-Center Cardiac Rehabilitation Israeli Working Group. [A multicenter intervention study on referral to cardiac rehabilitation after coronary artery bypass graft surgery: a 1-year follow-up of rehabilitation rates among USSR-born and veteran Israeli patients]. Harefuah. 2012 Sep;151(9):511-7, 558, 557. Hebrew.
Results Reference
result
PubMed Identifier
21982052
Citation
Dankner R, Geulayov G, Ziv A, Novikov I, Goldbourt U, Drory Y. The effect of an educational intervention on coronary artery bypass graft surgery patients' participation rate in cardiac rehabilitation programs: a controlled health care trial. BMC Cardiovasc Disord. 2011 Oct 8;11:60. doi: 10.1186/1471-2261-11-60.
Results Reference
result
PubMed Identifier
29332626
Citation
Geulayov G, Novikov I, Dankner D, Dankner R. Symptoms of depression and anxiety and 11-year all-cause mortality in men and women undergoing coronary artery bypass graft (CABG) surgery. J Psychosom Res. 2018 Feb;105:106-114. doi: 10.1016/j.jpsychores.2017.11.017. Epub 2017 Dec 1.
Results Reference
derived
Links:
URL
http://bjll.org/index.php/ejpch/article/view/684
Description
THE PSYCHOMETRIC PROPERTIES OF THE RUSSIAN VERSION OF THE MACNEW HEART DISEASE HEALTH-RELATED QUALITY OF LIFE SCALE IN PATIENTS UNDERGOING CORONARY ARTERY BYPASS GRAFTING SURGERY
URL
https://www.omicsonline.org/validation-of-the-hebrew-version-of-the-macnew-heart-disease-healthrelated-quality-of-life-questionnaire-in-patients-undergoing-coronary-artery-bypass-surgery-2155-9880.1000279.php?aid=21660
Description
Validation of the Hebrew Version of the MacNew Heart Disease Healthrelated Quality of Life Questionnaire in Patients Undergoing Coronary Artery Bypass Surgery

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

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