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| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00012818 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Heart Failure |
Behavioral: relaxation technique Behavioral: educational program |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy and Cost Effectiveness of Relaxation and Response to CHF |
| Estimated Enrollment: | 90 |
| Study Completion Date: | September 2003 |
| Arms | Assigned Interventions |
|---|---|
| 1 | Behavioral: relaxation technique Behavioral: educational program |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: CHF diagnosis, NY stage 2 or 3 Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| VA Boston Health Care System, Jamaica Plain | |
| Boston, Massachusetts, United States, 02130 | |
| VA New England Health Care System | |
| Bedford, Massachusetts, United States, 01730 | |
| Principal Investigator: | Ann M. Hendricks, PhD | VA Boston Health Care System, Jamaica Plain |
More Information
| Responsible Party: | Department of Veterans Affairs ( Hendricks, Ann - Principal Investigator ) |
| Study ID Numbers: | IIR 99-241 |
| Study First Received: | March 14, 2001 |
| Last Updated: | October 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00012818 History of Changes |
| Health Authority: | United States: Federal Government |
|
Heart Failure Heart Diseases |
|
Heart Failure Heart Diseases Cardiovascular Diseases |