Clinical trial NCT00356863: Effect of an Educational Intervention on Cardiac Patients' Participation Rate in Cardiac Rehabilitation Programs
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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Intervention
Awareness
Cardiac Rehabilitation (CR)
Coronary Artery Patients
Coronary Artery Bypass Grafting Surgery (CABG)
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: The Gertner Institute
name: Israel National Institute for Health Policy and Health Services Research
First posted: 2006-07-26
Enrollment: 1024
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Patients Participating in Cardiac Rehabilitation Programs (CRPs)1-year Post Coronary Artery Bypass Grafting (CABG)Surgery in the Intervention and Control Groups
timeFrame: 1 year
Secondary outcomes:
measure: MacNew Heart Disease Health Related Quality of Life (HRQL) Scale. A Self-administered Heart Disease-specific Health-related Quality of Life (HRQL) Instrument.
timeFrame: 1 year
Other outcomes:
measure: Cardiovascular Morbidity
timeFrame: 1 year
measure: Biochemical Markers
timeFrame: 1 year
measure: Medical Service Utilization
timeFrame: 1 year
measure: Anthropometric Measures
timeFrame: 1 year
measure: Lifestyle Habits (i.e. Smoking)
timeFrame: 1 year
measure: Employment Status
timeFrame: 1 year
measure: Depression & Anxiety
timeFrame: 1 year
measure: Physical Activity
timeFrame: 1 year
measure: Blood Pressure
timeFrame: 1 year follow up
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center, the Gertner institute for epidemiology and health service research
Study officials:
affiliation: The Gertner Institute for Epidemiology and Health Service Research, Sheba Medical Center
name: Rachel Dankner, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.