Improving Cardiac Rehabilitation Participation in Women and Men

The purpose of this study is to determine the effect of a pre-discharge written personal endorsement to the patient by the patient's attending cardiologist or cardiac surgeon (MD endorsement) to take part in the Cardiac Rehabilitation and Secondary Prevention (CR) program, in addition to the standard CR referral, compared to the standard CR referral alone, on CR program enrollment within 2 months of index hospital discharge following admission for myocardial infarction, unstable angina, coronary angioplasty, or coronary artery bypass.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Disease; Unstable Angina
• Intervention / Treatment: Behavioral: Standard Cardiac Rehabilitation referral; Behavioral: MD-endorsed Cardiac Rehabilitation referral

Detailed Description

There is compelling evidence that a comprehensive CR program comprising the delivery of lifestyle modifying education will reduce mortality, morbidity and improve quality of life in patients following myocardial infarction, angioplasty or, coronary artery bypass. However, less than 20% of eligible patients participate in CR programs. This study will look at a method of potentially improving enrollment and adherence to a CR program. It is expected that patients who receive the MD-endorsed referral will be more likely to attend the initial Orientation appointment and more closely adhere to the 6-month comprehensive CR program, as compared to the patients who receive a standard CR referral alone.

• Study Type: Interventional
• Enrollment (Actual): 1035
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is admitted to hospital for myocardial infarction (MI), unstable angina (UA), percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass surgery (CABS)
• Patient resides within 1 hour driving time from London

Exclusion Criteria:

• Inability to provide written informed consent or complete survey due to language or cognitive difficulties
• Previous cardiac rehabilitation participation
• Patient scheduled to undergo PTCA or CABS within two months following the index hospital discharge
• Inability to exercise due to musculoskeletal problems or previous or current stroke

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Comparator without MD endorsement of Cardiac Rehabilitation	Behavioral: Standard Cardiac Rehabilitation referral; Note to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician.; Other Names: Standard Referral to Cardiac Rehabilitation
Experimental: MD Endorsment of CR; Provided with MD endorsement of participation in Cardiac Rehabilitation	Behavioral: MD-endorsed Cardiac Rehabilitation referral; Note to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician.; Other Names: MD endorsed referral to Cardiac Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Attendance at initial CR orientation appointment within 2 months of index hospital discharge	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Impact of MD endorsement on number of patients attending CR program	3 months
Number of patients who continue to adhere to the 6-month CR program beyond the initial CR orientation appointment	8 months
Impact of other patient variables and how they influence participation in a CR program	8 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); AstraZeneca
• Investigators: Principal Investigator: Neville Suskin, MBChB, MSc, University of Western Ontario & London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 13, 2006
• First Submitted That Met QC Criteria: June 13, 2006
• First Posted (Estimate): June 14, 2006

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 26, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: coronary artery bypass surgery; Cardiac Rehabilitation; Improving Cardiac Rehabilitation Participation; coronary angioplasty
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Coronary Disease; Angina, Unstable
• Other Study ID Numbers: R-02-037; CIHR 56926 (Other Grant/Funding Number: CIHR)