Improving Cardiac Rehabilitation Participation in Women and Men

Myocardial Infarction Clinical Trial

Official title:

Improving Cardiac Rehabilitation Participation in Women and Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336830
• Other study ID #: R-02-037
• Secondary ID: CIHR 56926
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2006
• Last updated: March 26, 2014
• Start date: May 2003
• Est. completion date: December 2009

Study information

• Verified date: March 2014
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1035
• Est. completion date: December 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction
• Unstable Angina

Intervention

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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	AstraZeneca, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance at initial CR orientation appointment within 2 months of index hospital discharge		3 months	No
Secondary	Impact of MD endorsement on number of patients attending CR program		3 months	No
Secondary	Number of patients who continue to adhere to the 6-month CR program beyond the initial CR orientation appointment		8 months	No
Secondary	Impact of other patient variables and how they influence participation in a CR program		8 months	No