Readiness for Behavior Change After a Heart Attack

Not Applicable

Completed

• Conditions: Myocardial Infarction; Stable Angina; Coronary Artery Disease
• Interventions: Behavioral: Early appointment (within 10 days); Other: Routine referral (at 5 weeks)

• Registration Number: NCT01596036
• Lead Sponsor: Henry Ford Health System

Brief Summary

The purpose of this study is to test if an early appointment (within 10 days) when compared to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation orientation and subsequent enrollment into cardiac rehabilitation.

Detailed Description

Cardiac Rehabilitation is central to full recovery after a myocardial infarction or a cardiac stenting procedure. Yet, this therapy is underutilized across the nation. Henry Ford currently enrolls about 42% of eligible patients. In addition, it currently takes, on average, 42 +/-26 days from hospital discharge to enrollment in rehabilitation. During this delay, there is strong tendency to return to prior habits (sedentary lifestyle, smoking, poor nutrition, etc.) that led to the myocardial infarction in the first place. This delay is both 1) unnecessary and 2) probably harmful to the patients' readiness to make changes.

The investigators seek to perform a randomized controlled trial of early (7-10 days) vs standard referral (5-6 weeks) to cardiac rehabilitation. In addition, the investigators will examine the patients' readiness to change through the first 3 months of the post-hospitalization period and correlate that to their behavior and enrollment in cardiac rehabilitation. Assessment of readiness to change will be accomplished by serial survey's, which will be administered at discharge, 2 weeks, 5 weeks, and 13 weeks after discharge.

Patients will consent to take the survey and be observed in a clinical study. However, in order to avoid the Hawthorne Effect, patients they will not initially be aware of the primary hypothesis, as the investigators strongly believe this will affect the main behavior they are trying to measure. Full patient disclosure will occur at the end of the trial.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Primary Completion: 2012-06
• Status Verified: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Stable Angina
• Myocardial infarction
• Percutaneous coronary intervention
• willingness to participate and consent for medical record review
• willingness to complete survey's

Exclusion Criteria

• Recent illicit drug use
• Unstable psychiatric condition
• Moderate or severe dementia
• Inability to follow-up
• Leaving system with plans to enroll in cardiac rehabilitation out-of-system
• Inability to exercise (amputee, severe claudication)
• Unstable medical condition that would prevent regular exercise training
• Uncorrected severe aortic stenosis or severe mitral stenosis
• Referring physician feels that exercise is contra-indicated due to safety or other patient specific factors
• CABG, LVAD, or Heart Transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Appointment	Early appointment (within 10 days)	Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
Standard Referral	Routine referral (at 5 weeks)	Patients will receive an appointment to cardiac rehabilitation at 5 weeks from the date of their anticipated hospital discharge. A routine referral to cardiac rehabilitation will also occur in parallel. Consequently, it is possible that some patients will attend cardiac rehabilitation earlier than their assigned 5 week appointment.

Primary Outcome Measures

Name	Time	Method
Attendance at the free orientation session for Cardiac Rehabilitation	within 5 weeks of randomized apointment date

Secondary Outcome Measures

Name	Time	Method
Completion of at least one exercise session in Cardiac Rehabilitation	within 1 month of orientation date
Total number of cardiac rehabilitation exercise sessions attended	within 6 months of actual orientation date
Completion of the cardiac rehabilitation program	within 6 months	Completion is defined at attending the number of sessions agreed to at the onset of cardiac rehabilitation (e.g. agreeing to 3 session and attending 3) or attending 12 or more sessions.
Change in exercise capacity from the beginning to end of cardiac rehabilitation	within 6 months	exercise capacity will be calculated from treadmill workloads using standardized formulas published in the 8th edition of ACSM's Guidelines for exercise testing and prescription
Readiness to make positive behavior changes	within 3 months	Based on a 10 question survey, each patient will have a summary score to collapse across these questions. This summary score will be compared at 0, 5, and 13 weeks.

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States