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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356863
• Other study ID #: SHEBA-05-2374-RD-CTIL
• Status: Completed
• Phase: N/A
• First received: July 25, 2006
• Last updated: October 17, 2017
• Start date: February 2004
• Est. completion date: December 2009

Study information

• Verified date: October 2017
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1024
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center, the Gertner institute for epidemiology and health service research	Ramat Gan

Sponsors (3)

Lead Sponsor	Collaborator
Sheba Medical Center	Israel National Institute for Health Policy and Health Services Research, The Gertner Institute

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View 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 Cardiovas — View 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 rehabi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	1 year
Other	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.	1 year
Other	Medical Service Utilization	Visits to the emergency department during the year following CABG surgery	1 year
Other	Anthropometric Measures	Measurements of body mass index (BMI)	1 year
Other	Lifestyle Habits (i.e. Smoking)		1 year
Other	Employment Status	Number of patients fully employed in each arm	1 year
Other	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)	1 year
Other	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	1 year
Other	Blood Pressure	The pooled mean of 3 blood pressure measurements taken during the interview	1 year follow up
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.	1 year
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.	1 year

External Links

•   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
•   Validation of the Hebrew Version of the MacNew Heart Disease Healthrelated Quality of Life Questionnaire in Patients Undergoing Coronary Artery Bypass Surgery