Improving Cardiac Rehabilitation Participation in Women and Men

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00336830

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), AstraZeneca (Industry)

1,035

Enrollment

Location

Arms

Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Unstable Angina Coronary Disease	Behavioral: MD-endorsed Cardiac Rehabilitation referral Behavioral: Standard Cardiac Rehabilitation referral	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

1035 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Official Title:

Improving Cardiac Rehabilitation Participation in Women and Men

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Attendance at initial CR orientation appointment within 2 months of index hospital discharge [3 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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