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Efficacy and Cost Effectiveness of Relaxation and Response to CHF
This study has been completed.
Study NCT00012818   Information provided by Department of Veterans Affairs
First Received: March 14, 2001   Last Updated: October 31, 2008   History of Changes

March 14, 2001
October 31, 2008
 
 
 
 
Complete list of historical versions of study NCT00012818 on ClinicalTrials.gov Archive Site
 
 
 
Efficacy and Cost Effectiveness of Relaxation and Response to CHF
Efficacy and Cost Effectiveness of Relaxation and Response to CHF

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.

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.

 
Interventional
Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Chronic Heart Failure
  • Behavioral: relaxation technique
  • Behavioral: educational program
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
90
September 2003
 

Inclusion Criteria:

CHF diagnosis, NY stage 2 or 3

Exclusion Criteria:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012818
Hendricks, Ann - Principal Investigator, Department of Veterans Affairs
IIR 99-241
Department of Veterans Affairs
 
Principal Investigator: Ann M. Hendricks, PhD VA Boston Health Care System, Jamaica Plain
Department of Veterans Affairs
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP