Efficacy and Cost Effectiveness of Relaxation and Response to CHF
研究概览
详细说明
Background:
Despite the development of significant pharmaceutical treatments, morbidity and mortality of chronic heart failure (CHF) patients remain high, patients� quality of life is poor, and their health care utilization is heavy. It is therefore important to find a cost effective non-pharmaceutical treatment to help CHF patients manage the disease. The relaxation response has been found to be effective in managing CHF-related conditions. With its favorable physiological changes, the relaxation response is likely to benefit CHF patients.
Objectives:
1. To evaluate the effects of a 15-week relaxation response intervention program on improving functional capacity and health-related quality of life as compared with an ongoing 15-week educational program for cardiac disease management, and a control group of usual cardiac care; 2. To identify the costs of conducting the intervention and the cardiac care education and the costs associated with cardiac care services; and to compare cost among three study groups.
Methods:
This is a single-blind three-armed randomized trial in CHF patients who receive care at the Boston VA Medical Center. Enrolled patients are randomly assigned, with equal numbers, to one of the three study groups. Outcomes include cardiac functional capacity and self-reported health-related quality of life. We also conduct a qualitative study to interview patients by phone about their experience in the study.
Status:
This project has completed the data collection phase and is in the data analysis phase.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Bedford、Massachusetts、美国、01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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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:
CHF diagnosis, NY stage 2 or 3
Exclusion Criteria:
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:手臂 1
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合作者和调查者
调查人员
- 首席研究员:Ann M. Hendricks, PhD、Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
- 首席研究员:Bei-Hung Chang, ScD、Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
出版物和有用的链接
一般刊物
- Chang BH, Jones D, Hendricks A, Boehmer U, Locastro JS, Slawsky M. Relaxation response for Veterans Affairs patients with congestive heart failure: results from a qualitative study within a clinical trial. Prev Cardiol. 2004 Spring;7(2):64-70.
- Chang BH, Hendricks A, Zhao Y, Rothendler JA, LoCastro JS, Slawsky MT. A relaxation response randomized trial on patients with chronic heart failure. J Cardiopulm Rehabil. 2005 May-Jun;25(3):149-57. doi: 10.1097/00008483-200505000-00005.
- Chang BH, Hendricks AM, Slawsky MT, Locastro JS. Patient recruitment to a randomized clinical trial of behavioral therapy for chronic heart failure. BMC Med Res Methodol. 2004 Apr 17;4:8. doi: 10.1186/1471-2288-4-8.
研究记录日期
研究主要日期
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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relaxation technique的临床试验
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Kessler FoundationNational Multiple Sclerosis Society招聘中
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Second Affiliated Hospital, School of Medicine,...The First Affiliated Hospital of Nanchang University; Chinese PLA General Hospital; The Affiliated... 和其他合作者招聘中