Clinical trial NCT00336830: Improving Cardiac Rehabilitation Participation in Women and Men
Official title: Improving Cardiac Rehabilitation Participation in Women and Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Unstable Angina
Coronary Disease
Keywords: Cardiac Rehabilitation
Improving Cardiac Rehabilitation Participation
coronary angioplasty
coronary artery bypass surgery
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: AstraZeneca
First posted: 2006-06-14
Enrollment: 1035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Attendance at initial CR orientation appointment within 2 months of index hospital discharge
timeFrame: 3 months
Secondary outcomes:
measure: Impact of MD endorsement on number of patients attending CR program
timeFrame: 3 months
measure: Number of patients who continue to adhere to the 6-month CR program beyond the initial CR orientation appointment
timeFrame: 8 months
measure: Impact of other patient variables and how they influence participation in a CR program
timeFrame: 8 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Western Ontario & London Health Sciences Centre
name: Neville Suskin, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
References: