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IIR 99-241 – HSR&D Study

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IIR 99-241
Efficacy and Cost Effectiveness of Relaxation and Response to CHF
Ann M. Hendricks PhD
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, MA
Funding Period: January 2000 - September 2003

BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
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.

FINDINGS/RESULTS:
The qualitative sub-study on 5 of the 97 enrolled patients has been completed. A manuscript has been written based on the results of the qualitative study and is currently under review. Half of the 20 RR group interviewees reported physician and 13 reported emotional improvements. These improvements went beyond disease management to life style changes and improved family/friends relationships. Five of 16 EDU group interviewees reported physical and 8 reported emotional improvements. These improvements consisted of a better understanding of the disease and resulted in feeling more at ease. None of the UC group interviewees reported any improvement from study participation. Although group support contributed to the benefits reported by RR and EDU groups, the use of the RR techniques seems to be the factor that distinguished the improvements of the two. The results from the quantitative data are not available yet as this time.

IMPACT:
The study has the potential to contribute important clinical knowledge in treating patients with CHF both within and outside VA. If the relaxation response intervention is shown to be effective and/or cost effective, a wide dissemination of this intervention could be implemented to benefit veterans throughout the nation.

PUBLICATIONS:

Journal Articles

  1. Chang BH, Hendricks A, Zhao Y, Rothendler JA, LoCastro JS, Slawsky MT. A relaxation response randomized trial on patients with chronic heart failure. Journal of Cardiopulmonary Rehabilitation. 2005 May 1; 25(3):149-57.
  2. Chang BH, Hendricks AM, Slawsky MT, Locastro JS. Patient recruitment to a randomized clinical trial of behavioral therapy for chronic heart failure. BMC medical research methodology. 2004 Apr 17; 4:8.
  3. 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. Preventive Cardiology. 2004 Mar 1; 7(2):64-70.
Conference Presentations

  1. Chang BH, Hendricks A, Zhao Y, Rothendler JA, Locastro JS, Slawsky MT. A Relaxation Response Randomized Trial on Chronic Heart Failure Patients. Paper presented at: American Public Health Association Annual Meeting and Exposition; 2004 Nov 1; Washington, DC.
  2. Hyman K, Kim E, Locastro J, Chang B, Hendricks A. The Relaxation Response in Congestive Heart Failure: Older Patients Can Adopt New Health Behaviors. Paper presented at: Complementary, Alternative and Integrative Medicine Research International Annual Scientific Conference; 2002 Apr 20; Boston, MA.
  3. Chang B, Zhang S, Hyman K, Hendricks A, Locastro J, Slawsky M, Rothendler J. The Effect of Relaxation Response on Quality of Life in Patients with Chronic Heart Failure. Paper presented at: Complementary, Alternative and Integrative Medicine Research International Annual Scientific Conference; 2002 Apr 1; Boston, MA.


DRA: Health Systems
DRE: Epidemiology, Treatment - Observational, Prevention
Keywords: Chronic heart failure
MeSH Terms: none

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