Readiness for Behavior Change After a Heart Attack (ENROLL)
Primary Purpose
Myocardial Infarction, Stable Angina, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early appointment (within 10 days)
Routine referral (at 5 weeks)
Sponsored by
About this trial
This is an interventional health services research trial for Myocardial Infarction focused on measuring cardiac rehabilitation, referral, enrollment, timing
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
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Early Appointment
Standard Referral
Arm Description
Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
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.
Outcomes
Primary Outcome Measures
Attendance at the free orientation session for Cardiac Rehabilitation
Secondary Outcome Measures
Completion of at least one exercise session in Cardiac Rehabilitation
Total number of cardiac rehabilitation exercise sessions attended
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.
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
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.
Full Information
NCT ID
NCT01596036
First Posted
May 9, 2012
Last Updated
November 13, 2012
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT01596036
Brief Title
Readiness for Behavior Change After a Heart Attack
Acronym
ENROLL
Official Title
Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Stable Angina, Coronary Artery Disease
Keywords
cardiac rehabilitation, referral, enrollment, timing
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Appointment
Arm Type
Experimental
Arm Description
Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
Arm Title
Standard Referral
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early appointment (within 10 days)
Intervention Description
Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
Intervention Type
Other
Intervention Name(s)
Routine referral (at 5 weeks)
Intervention Description
Standard Referral to Cardiac Rehabilitation
Primary Outcome Measure Information:
Title
Attendance at the free orientation session for Cardiac Rehabilitation
Time Frame
within 5 weeks of randomized apointment date
Secondary Outcome Measure Information:
Title
Completion of at least one exercise session in Cardiac Rehabilitation
Time Frame
within 1 month of orientation date
Title
Total number of cardiac rehabilitation exercise sessions attended
Time Frame
within 6 months of actual orientation date
Title
Completion of the cardiac rehabilitation program
Description
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.
Time Frame
within 6 months
Title
Change in exercise capacity from the beginning to end of cardiac rehabilitation
Description
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
Time Frame
within 6 months
Title
Readiness to make positive behavior changes
Description
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.
Time Frame
within 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quinn R Pack, MD
Organizational Affiliation
Henry Ford Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven J Keteyian, PhD
Organizational Affiliation
Henry Ford Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22082676
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.
Results Reference
background
PubMed Identifier
21826016
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.
Results Reference
background
PubMed Identifier
23250992
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.
Results Reference
derived
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Readiness for Behavior Change After a Heart Attack
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