Efficacy and Cost Effectiveness of Relaxation and Response to CHF
- Conditions
- Chronic Heart Failure
- Interventions
- Behavioral: relaxation techniqueBehavioral: educational program
- Registration Number
- NCT00012818
- Lead Sponsor
- US Department of Veterans Affairs
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
CHF diagnosis, NY stage 2 or 3
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 educational program - Arm 1 relaxation technique -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
🇺🇸Bedford, Massachusetts, United States