Readiness for Behavior Change After a Heart Attack (ENROLL)
Stages of Change Through the Cardiac Rehabilitation Experience After a Recent Hospitalization
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Early Appointment
Patients will receive an early appointment (within 10 days) from the time of their anticipated hospital discharge
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Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
|
|
安慰剂比较: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.
|
Standard Referral to Cardiac Rehabilitation
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Attendance at the free orientation session for Cardiac Rehabilitation
大体时间:within 5 weeks of randomized apointment date
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within 5 weeks of randomized apointment date
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Completion of at least one exercise session in Cardiac Rehabilitation
大体时间:within 1 month of orientation date
|
within 1 month of orientation date
|
|
|
Total number of cardiac rehabilitation exercise sessions attended
大体时间:within 6 months of actual orientation date
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within 6 months of actual orientation date
|
|
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Completion of the cardiac rehabilitation program
大体时间:within 6 months
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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.
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within 6 months
|
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Change in exercise capacity from the beginning to end of cardiac rehabilitation
大体时间:within 6 months
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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
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within 6 months
|
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Readiness to make positive behavior changes
大体时间:within 3 months
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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.
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within 3 months
|
合作者和调查者
调查人员
- 首席研究员:Quinn R Pack, MD、Henry Ford Hospital
- 研究主任:Steven J Keteyian, PhD、Henry Ford Hospital
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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