NCT00336830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,035

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 27, 2014

Status Verified

March 1, 2014

Enrollment Period

4.1 years

First QC Date

June 13, 2006

Last Update Submit

March 26, 2014

Conditions

Keywords

Cardiac RehabilitationImproving Cardiac Rehabilitation Participationcoronary angioplastycoronary artery bypass surgery

Outcome Measures

Primary Outcomes (1)

  • Attendance at initial CR orientation appointment within 2 months of index hospital discharge

    3 months

Secondary Outcomes (3)

  • Impact of MD endorsement on number of patients attending CR program

    3 months

  • Number of patients who continue to adhere to the 6-month CR program beyond the initial CR orientation appointment

    8 months

  • Impact of other patient variables and how they influence participation in a CR program

    8 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Comparator without MD endorsement of Cardiac Rehabilitation

Behavioral: Standard Cardiac Rehabilitation referral

MD Endorsment of CR

EXPERIMENTAL

Provided with MD endorsement of participation in Cardiac Rehabilitation

Behavioral: MD-endorsed Cardiac Rehabilitation referral

Interventions

Note to patient with general description of the Cardiac Rehabilitation program with signature and strong recommendation from attending physician.

Also known as: MD endorsed referral to Cardiac Rehabilitation
MD Endorsment of CR

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

Also known as: Standard Referral to Cardiac Rehabilitation
Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Myocardial InfarctionAngina, UnstableCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Neville Suskin, MBChB, MSc

    University of Western Ontario & London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2006

First Posted

June 14, 2006

Study Start

May 1, 2003

Primary Completion

June 1, 2007

Study Completion

December 1, 2009

Last Updated

March 27, 2014

Record last verified: 2014-03

Locations