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Improving Cardiac Rehabilitation Participation in Women and Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Lawson Health Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
AstraZeneca
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00336830
First received: June 13, 2006
Last updated: July 7, 2009
Last verified: July 2009
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Improving Cardiac Rehabilitation Participation in Women and Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Attendance at initial CR orientation appointment within 2 months of index hospital discharge [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of MD endorsement on number of patients attending CR program [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of patients who continue to adhere to the 6-month CR program beyond the initial CR orientation appointment [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Impact of other patient variables and how they influence participation in a CR program [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1035
Study Start Date: May 2003
Estimated Study Completion Date: December 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Behavioral: Standard Cardiac Rehabilitation referral
    Note to patient with general description of the Cardiac Rehabilitation program without signature or recommendation from attending physician.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Neville Suskin, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00336830     History of Changes
Other Study ID Numbers: R-02-037, CIHR 56926
Study First Received: June 13, 2006
Last Updated: July 7, 2009
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on June 17, 2013