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Readiness for Behavior Change After a Heart Attack

Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01596036
Acronym
ENROLL
Enrollment
150
Registered
2012-05-10
Start date
2011-02-28
Completion date
2012-11-30
Last updated
2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Infarction, Stable Angina

Keywords

cardiac rehabilitation, referral, enrollment, timing

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.

Interventions

BEHAVIORALEarly appointment (within 10 days)

Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.

OTHERRoutine referral (at 5 weeks)

Standard Referral to Cardiac Rehabilitation

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Attendance at the free orientation session for Cardiac Rehabilitationwithin 5 weeks of randomized apointment date

Secondary

MeasureTime frameDescription
Completion of at least one exercise session in Cardiac Rehabilitationwithin 1 month of orientation date
Total number of cardiac rehabilitation exercise sessions attendedwithin 6 months of actual orientation date
Completion of the cardiac rehabilitation programwithin 6 monthsCompletion 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.
Readiness to make positive behavior changeswithin 3 monthsBased 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.
Change in exercise capacity from the beginning to end of cardiac rehabilitationwithin 6 monthsexercise capacity will be calculated from treadmill workloads using standardized formulas published in the 8th edition of ACSM's Guidelines for exercise testing and prescription

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026