Clinical trial NCT01596036: Readiness for Behavior Change After a Heart Attack
Official title: Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Stable Angina
Coronary Artery Disease
Keywords: cardiac rehabilitation
referral
enrollment
timing
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance at the free orientation session for Cardiac Rehabilitation
timeFrame: within 5 weeks of randomized apointment date
Secondary outcomes:
measure: Completion of at least one exercise session in Cardiac Rehabilitation
timeFrame: within 1 month of orientation date
measure: Total number of cardiac rehabilitation exercise sessions attended
timeFrame: within 6 months of actual orientation date
measure: Completion of the cardiac rehabilitation program
timeFrame: within 6 months
measure: Change in exercise capacity from the beginning to end of cardiac rehabilitation
timeFrame: within 6 months
measure: Readiness to make positive behavior changes
timeFrame: within 3 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Quinn R Pack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Hospital
name: Steven J Keteyian, PhD
role: STUDY_DIRECTOR
References:
citation: Balady GJ, Ades PA, Bittner VA, Franklin BA, Gordon NF, Thomas RJ, Tomaselli GF, Yancy CW; American Heart Association Science Advisory and Coordinating Committee. Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association. Circulation. 2011 Dec 20;124(25):2951-60. doi: 10.1161/CIR.0b013e31823b21e2. Epub 2011 Nov 14. No abstract available.
citation: Russell KL, Holloway TM, Brum M, Caruso V, Chessex C, Grace SL. Cardiac rehabilitation wait times: effect on enrollment. J Cardiopulm Rehabil Prev. 2011 Nov-Dec;31(6):373-7. doi: 10.1097/HCR.0b013e318228a32f.
citation: Pack QR, Mansour M, Barboza JS, Hibner BA, Mahan MG, Ehrman JK, Vanzant MA, Schairer JR, Keteyian SJ. An early appointment to outpatient cardiac rehabilitation at hospital discharge improves attendance at orientation: a randomized, single-blind, controlled trial. Circulation. 2013 Jan 22;127(3):349-55. doi: 10.1161/CIRCULATIONAHA.112.121996. Epub 2012 Dec 18.