Improving Cardiac Rehabilitation Participation in Women and Men

NCT ID: NCT00336830

Last Updated: 2014-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1035 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction Unstable Angina Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual Care

Comparator without MD endorsement of Cardiac Rehabilitation

Group Type ACTIVE_COMPARATOR

Standard Cardiac Rehabilitation referral

Intervention Type BEHAVIORAL

Note to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician.

MD Endorsment of CR

Provided with MD endorsement of participation in Cardiac Rehabilitation

Group Type EXPERIMENTAL

MD-endorsed Cardiac Rehabilitation referral

Intervention Type BEHAVIORAL

Note to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician.

Interventions

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MD-endorsed Cardiac Rehabilitation referral

Note to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician.

Intervention Type BEHAVIORAL

Standard Cardiac Rehabilitation referral

Note to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician.

Intervention Type BEHAVIORAL

Other Intervention Names

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MD endorsed referral to Cardiac Rehabilitation Standard Referral to Cardiac Rehabilitation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Neville Suskin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neville Suskin, MBChB, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario & London Health Sciences Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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CIHR 56926

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R-02-037

Identifier Type: -

Identifier Source: org_study_id

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