Improving Cardiac Rehabilitation Participation in Women and Men
March 26, 2014 updated by: Neville Suskin, Lawson Health Research Institute
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5A5
- London Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual Care
Comparator without MD endorsement of Cardiac Rehabilitation
|
Note to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician.
Other Names:
|
|
Experimental: MD Endorsment of CR
Provided with MD endorsement of participation in Cardiac Rehabilitation
|
Note to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician.
Other Names:
|
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
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Impact of MD endorsement on number of patients attending CR program
Time Frame: 3 months
|
3 months
|
|
Number of patients who continue to adhere to the 6-month CR program beyond the initial CR orientation appointment
Time Frame: 8 months
|
8 months
|
|
Impact of other patient variables and how they influence participation in a CR program
Time Frame: 8 months
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neville Suskin, MBChB, MSc, University of Western Ontario & London Health Sciences Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-02-037
- CIHR 56926 (Other Grant/Funding Number: CIHR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.