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

This study has been completed.
Sponsor:
Collaborators:
The Gertner Institute for Epidemiology and Health Policy Research
Israel National Institute for Health Policy and Health Services Research
Information provided by (Responsible Party):
Dr. Rachel Dankner, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00356863
First received: July 25, 2006
Last updated: February 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Behavioral: Increasing awareness to cardiac rehabilitation programs

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 1024
Study Start Date: February 2004
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Explanation on cardiac rehabilitation
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.
Behavioral: 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.
Other Name: Improving participation at cardiac rehabilitation programs
No Intervention: Usual care with no intervention
Patients recruited to the study received the usual care without any additional effort to increase their awareness or the ward's awareness to cardiac rehabilitation.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356863

Locations
Israel
Sheba Medical Center, the Gertner institute for epidemiology and health service research
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
The Gertner Institute for Epidemiology and Health Policy Research
Israel National Institute for Health Policy and Health Services Research
Investigators
Principal Investigator: Rachel Dankner, MD MPH The Gertner Institute for Epidemiology and Health Service Research, Sheba Medical Center
  More Information

Additional Information:
No publications provided by Sheba Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Rachel Dankner, Senior investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00356863     History of Changes
Other Study ID Numbers: SHEBA-05-2374-RD-CTIL
Study First Received: July 25, 2006
Results First Received: June 8, 2010
Last Updated: February 26, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Intervention
Awareness
Cardiac Rehabilitation (CR)
Coronary Artery Patients
Coronary Artery Bypass Grafting Surgery (CABG)

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014