Assessing Pain as a Mediator of Behavior Change in Post-coronary Angioplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- successful behavior change over 12 months
研究概览
简要总结
The focus of this secondary data analysis is to determine whether pain due to a combination of both cardiac and non cardiac sources operates as a mediator of behavior change, an area that has not been previously evaluated.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Non-participants in the Healthy Behavior Trial
结局指标
主要结局
successful behavior change over 12 months
时间窗: Baseline, 3, 6, 9 and 12 months
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.
次要结局
- Quality of life(Within-patient change from baseline to 12 months)