Readiness for Behavior Change After a Heart Attack

Coronary Artery Disease Clinical Trial

— ENROLL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596036
• Other study ID #: HFHS 6649
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: November 13, 2012
• Start date: February 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction
• Myocardial Ischemia
• Stable Angina

Intervention

Behavioral:
• Early appointment (within 10 days)
Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.

Other:
• Routine referral (at 5 weeks)
Standard Referral to Cardiac Rehabilitation

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance at the free orientation session for Cardiac Rehabilitation		within 5 weeks of randomized apointment date	No
Secondary	Completion of at least one exercise session in Cardiac Rehabilitation		within 1 month of orientation date	No
Secondary	Total number of cardiac rehabilitation exercise sessions attended		within 6 months of actual orientation date	No
Secondary	Completion of the cardiac rehabilitation program	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.	within 6 months	No
Secondary	Change in exercise capacity from the beginning to end of cardiac rehabilitation	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	within 6 months	No
Secondary	Readiness to make positive behavior changes	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.	within 3 months	No