跳至主要内容
临床试验/NCT00536224
NCT00536224已完成不适用

Brief Intervention to Promote Cardiovascular Risk Reduction in Patients Admitted to Chest Pain Observation Units

David A Katz2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2007年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)

研究概览

简要总结

The purpose of this study is to determine whether a brief counseling intervention initiated in the chest pain observation unit has a significant impact upon the health attitudes (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking) of emergency department patients.

详细描述

Increasingly, emergency department patients for whom a non-ischemic etiology of acute coronary syndrome (ACS) symptoms cannot be identified undergo further evaluation to rule out myocardial ischemia and appraisal of cardiovascular risk factors (CRFs) in chest pain observation units (CPOUs). CPOU admission may represent a "teachable moment," but there has been little research on the effectiveness of brief, practical interventions for cardiovascular risk reduction in this population, despite the fact that the vast majority of these patients have at least one modifiable CRF and many do not receive regular primary care follow-up. The purpose of this study is to determine whether a brief counseling intervention initiated in the CPOU has a significant impact upon health attitudes (readiness to change) and cardiovascular risk-related behaviors (diet, exercise, and smoking). Based on the Health Belief Model (HBM), the intervention is designed to provide patients with tailored information on their cardiovascular risk, to negotiate goals for change, and to build problem-solving skills. All participants who are admitted to the CPOU for evaluation of ACS symptoms will be randomized to brief intervention (face-to-face counseling in the CPOU, coupled with telephone counseling at 4 weeks) or to minimal intervention (booklet with general information on CRFs) after a negative initial troponin measurement. We will conduct a baseline survey and follow-up telephone interviews at 2- and 6-month to assess stage of change and CRF-related behaviors. Linear mixed models and logistic regression (with generalized estimating equations) will be used to compare continuous and dichotomous behavioral outcomes across treatment arms, respectively. The proposed trial will evaluate the feasibility and effectiveness of delivering brief interventions for cardiovascular risk reduction in the CPOU setting, will provide insight into mechanisms of behavior change in these patients, and will guide the development of future case management interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least one modifiable cardiovascular risk factor (smoking, hyperlipidemia, hypertension, diabetes mellitus, obesity)

排除标准

  • Patients who "rule-in" for myocardial ischemia at initial testing
  • Terminally ill (expected to survive less than 3 months)
  • Unavailable for 6-month follow-up
  • Cannot be contacted by telephone
  • Institutionalized persons (prisoners, nursing home residents)
  • Unable to provide informed consent (impaired mental status, unable to speak English)

研究组 & 干预措施

2

Active Comparator

Minimal counseling

干预措施: Minimal counseling (Behavioral)

1

Experimental

Full counseling

干预措施: Full counseling (Behavioral)

结局指标

主要结局

Stage of change for cardiovascular risk-related behaviors (diet, exercise, and smoking)

时间窗: 2- and 6-months

Self-reported cardiovascular health behaviors (diet, physical activity, and smoking cessation)

时间窗: 2- and 6-months

次要结局

未报告次要终点

研究者

发起方
David A Katz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David A Katz

Associate Professor of Medicine

University of Iowa

研究点 (2)

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