Readiness for Behavior Change After a Heart Attack (ENROLL)
|ClinicalTrials.gov Identifier: NCT01596036|
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : November 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction Stable Angina Coronary Artery Disease||Behavioral: Early appointment (within 10 days) Other: Routine referral (at 5 weeks)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Early Appointment
Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
Behavioral: Early appointment (within 10 days)
Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
Placebo Comparator: Standard Referral
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.
Other: Routine referral (at 5 weeks)
Standard Referral to Cardiac Rehabilitation
- Attendance at the free orientation session for Cardiac Rehabilitation [ Time Frame: within 5 weeks of randomized apointment date ]
- Completion of at least one exercise session in Cardiac Rehabilitation [ Time Frame: within 1 month of orientation date ]
- Total number of cardiac rehabilitation exercise sessions attended [ Time Frame: within 6 months of actual orientation date ]
- Completion of the cardiac rehabilitation program [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596036
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Quinn R Pack, MD||Henry Ford Hospital|
|Study Director:||Steven J Keteyian, PhD||Henry Ford Hospital|