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Efficacy and Cost Effectiveness of Relaxation and Response to CHF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012818
First received: March 14, 2001
Last updated: August 1, 2012
Last verified: February 2007

March 14, 2001
August 1, 2012
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Complete list of historical versions of study NCT00012818 on ClinicalTrials.gov Archive Site
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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
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Chronic Heart Failure
  • Behavioral: relaxation technique
  • Behavioral: educational program
Arm 1
Interventions:
  • Behavioral: relaxation technique
  • Behavioral: educational program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 2003
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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
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NCT00012818
IIR 99-241
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Ann M. Hendricks, PhD VA Boston Health Care System, Jamaica Plain
Principal Investigator: Bei-Hung Chang, ScD VA Boston Healthcare System
Department of Veterans Affairs
February 2007

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