Assessing Pain as a Mediator of Behavior Change in Post-coronary Angioplasty Patients
研究概览
详细说明
This is a secondary data analysis of an existing dataset generated from The Healthy Behavior Trial, an NHLBI-funded randomized controlled trial that enrolled 660 post-coronary angioplasty patients between October 1999 and March 2001. This study employed a behavioral intervention to motivate PCI patients to adopt health behaviors in order to reduce major cardiac and neurologic morbidity and mortality. Patients in the experimental arm were told their estimated biologic age (calculated from the health risk assessment) and risk factors were presented in terms of "biologic age reduction" that could be achieved if a change was made in each health behavior area. Those in the control arm were provided with risk factors (also obtained from the health risk assessment) and told that changing each health behavior could "increase your lifespan."
Specific Aims:
Utilizing 12 month longitudinal data for patients with cardiovascular disease who have undergone coronary angioplasty we will:
Specific aim 1: Determine if pain is a mediator of health behavior change over 12 months.
Specific aim 2: Assess behavior change patterns over 12 months, stratifying for degree of pain, depression and/or stress.
Specific aim 3: Evaluate the effect of pain on quality of life (physical, social, role-physical, role-emotional, vitality, mental health, bodily pain and general health domains), combined major cardiac and neurologic morbidity/mortality and hospitalizations over 12 months.
研究类型
注册 (实际的)
联系人和位置
学习地点
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New York
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New York、New York、美国、10065
- Weill Cornell Medical College
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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
取样方法
研究人群
描述
Inclusion Criteria:
- all patients in the database who had participated in the Healthy Behavior Trial. The Healthy Behavior Trial was a randomized controlled trial of a psychoeducational intervention designed to motivate multi-behavior change (changing 2 or more cardiovascular risk factors) in post-coronary angioplasty patients over the course of 24 months.
Exclusion Criteria:
- Non-participants in the Healthy Behavior Trial
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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successful behavior change over 12 months
大体时间：Baseline, 3, 6, 9 and 12 months
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Health behavior will be examined in five areas: overall physical activity, strength training, aerobic activity, weight loss, and smoking cessation.
Successful health behavior change will be defined as "action" (engaging in the behavior < six months) or "maintenance" (engaging in the behavior ≥ six months to five years), according to the Transtheoretical Model.
We will use self-reported data.
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Baseline, 3, 6, 9 and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of life
大体时间：Within-patient change from baseline to 12 months
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The SF-36 health survey will be the primary measure of quality of life.
Each of the eight individual domain scores will be evaluated (physical, social, role-physical, role-emotional, vitality, mental health, bodily pain and general health) and the within-patient change from baseline to 12 months will be calculated.
The physical and mental component summary measures will also be calculated, as will the within-patient change from baseline to 12 months for the component scores.
We will assess these measures as both continuous and dichotomous measures.
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Within-patient change from baseline to 12 months
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合作者和调查者
调查人员
- 首席研究员：Janey C Peterson, EdD, MS, RN、Weill Medical College of Cornell University
出版物和有用的链接
有用的网址
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
生活质量的临床试验
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Swansea University完全的
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Yale-NUS College完全的
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Scripps Translational Science Institute完全的
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Peking Union Medical College Hospital尚未招聘