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

July 25, 2006
February 26, 2012
February 2004
June 2009   (final data collection date for primary outcome 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 [ 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.
Proportion of CRP participation 1-year post surgery in the intervention versus control groups
Complete list of historical versions of study NCT00356863 on ClinicalTrials.gov Archive Site
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.
  • One-year follow-up:
  • Cardiovascular and other morbidity
  • Biochemical markers
  • Left ventricular ejection fraction
  • Medication use
  • Medical service utilization
  • anthropometric measures
  • lifestyle habits (i.e. physical activity, smoking, diet)
  • employment status
  • functional capacity
  • depression & anxiety
  • quality of life
Not Provided
Not Provided
 
Effect of an Educational Intervention on Cardiac Patients' Participation Rate in Cardiac Rehabilitation Programs
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Coronary Artery Disease
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
  • 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.
    Intervention: Behavioral: Increasing awareness to 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1024
December 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00356863
SHEBA-05-2374-RD-CTIL
No
Dr. Rachel Dankner, Sheba Medical Center
Sheba Medical Center
  • The Gertner Institute for Epidemiology and Health Policy Research
  • Israel National Institute for Health Policy and Health Services Research
Principal Investigator: Rachel Dankner, MD MPH The Gertner Institute for Epidemiology and Health Service Research, Sheba Medical Center
Sheba Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP