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Improving Cardiac Rehabilitation Participation in Women and Men

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ClinicalTrials.gov Identifier: NCT00336830
Recruitment Status : Completed
First Posted : June 14, 2006
Last Update Posted : March 27, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 2003
Primary Completion Date : June 2007
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: MD endorsed referral to Cardiac Rehabilitation


Outcome Measures

Primary Outcome Measures :
  1. Attendance at initial CR orientation appointment within 2 months of index hospital discharge [ Time Frame: 3 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336830


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
AstraZeneca
Investigators
Principal Investigator: Neville Suskin, MBChB, MSc University of Western Ontario & London Health Sciences Centre
More Information

Responsible Party: Neville Suskin, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00336830     History of Changes
Other Study ID Numbers: R-02-037
CIHR 56926 ( Other Grant/Funding Number: CIHR )
First Posted: June 14, 2006    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014

Keywords provided by Neville Suskin, Lawson Health Research Institute:
Cardiac Rehabilitation
Improving Cardiac Rehabilitation Participation
coronary angioplasty
coronary artery bypass surgery

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms