Improving Cardiac Rehabilitation Participation in Women and Men

Phase 3

Completed

• Conditions: Myocardial Infarction; Unstable Angina; Coronary Disease
• Interventions: Behavioral: Standard Cardiac Rehabilitation referral; Behavioral: MD-endorsed Cardiac Rehabilitation referral

• Registration Number: NCT00336830
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

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 Timeline

• Study Start: 2003-05
• Study First Submitted: 2006-06-13
• Study First Submitted QC: 2006-06-13
• Study First Posted: 2006-06-14
• Primary Completion: 2007-06
• Study Completion: 2009-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-26
• Last Update Posted: 2014-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1035

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Standard Cardiac Rehabilitation referral	Comparator without MD endorsement of Cardiac Rehabilitation
MD Endorsment of CR	MD-endorsed Cardiac Rehabilitation referral	Provided with MD endorsement of participation in Cardiac Rehabilitation

Primary Outcome Measures

Name	Time	Method
Attendance at initial CR orientation appointment within 2 months of index hospital discharge	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada