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临床试验/NCT01596036
NCT01596036已完成不适用

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

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Attendance at the free orientation session for Cardiac Rehabilitation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable Angina
  • Myocardial infarction
  • Percutaneous coronary intervention
  • willingness to participate and consent for medical record review
  • willingness to complete survey's

排除标准

  • 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

结局指标

主要结局

Attendance at the free orientation session for Cardiac Rehabilitation

时间窗: within 5 weeks of randomized apointment date

次要结局

  • Completion of at least one exercise session in Cardiac Rehabilitation(within 1 month of orientation date)
  • Total number of cardiac rehabilitation exercise sessions attended(within 6 months of actual orientation date)
  • Completion of the cardiac rehabilitation program(within 6 months)
  • Change in exercise capacity from the beginning to end of cardiac rehabilitation(within 6 months)
  • Readiness to make positive behavior changes(within 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Quinn R Pack

Cardiology Fellow

Henry Ford Health System

研究点 (2)

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