Chronic heart failure (CHF) is a prevalent and costly disease. Because the incidence is higher among the elderly, the number of CHF patients is expected to rise as the population ages. Despite the development of significant pharmaceutical treatments, morbidity and mortality of CHF patients remain high, patients? quality of life is poor, and their health care utilization is heavy. Exercise training and biobehavioral interventions have been suggested as adjuvant therapy to drug protocols. Among biobehavioral interventions, the relaxation response has been found to be effective in managing CHF-related conditions such as hypertension and coronary artery disease.

The relaxation response is a state in which individuals evoke a bodily calm that has the opposite effect of the fight-or-flight response, with concomitant favorable physiological changes that are likely to reduce symptoms and improve the quality of life of CHF patients. Hence, it may lead to lower health care utilization and reduce costs. The study?s objectives are: 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 on-going 15-week educational program for cardiac disease management, and a control group of usual cardiac care; 2. To identify the costs of conducting the relaxation response intervention and the program of cardiac care education, as well as the costs associated with utilization of cardiac care services for patients in each of the three study groups; and to compare cost among three study groups adjusting for patient characteristics. We propose to conduct a single-blind three-armed randomized trial to evaluate the efficacy and cost of the relaxation response in CHF patients at the VA. Two types of control groups will be used in this trial: an educational program and a usual care group. The trial will be conducted in 120 ambulatory CHF patients who receive health care at the Boston and West Roxbury VA medical centers. Patients will be randomly assigned, with equal numbers, to one of the three study groups. Outcomes include cardiac functional capacity and health-related quality of life to be reported by the patients. These measures will be administered to all 120 patients at baseline, at the end of the 15-week intervention, and at 6 and 12-month follow-up. We will collect information on costs associated with the intervention and control programs, estimate costs for health services utilization by patients, and conduct cost analyses.

Condition	Treatment or Intervention
Heart Failure, Congestive	Behavior: Evaluate the efficacy and cost of the relaxation response in CHF patients at the VA.

Genders Eligible for Study:  Both

Criteria

Ambulatory CHF patients who receive health care at the Boston and West Roxbury VA medical centers.

Massachusetts
      Edith Nourse Rogers Memoral Veterans Hospital, Bedford,  Massachusetts,  01730,  United States; Recruiting
      Edith Nourse Rogers Memoral Veterans Hospital, Bedford,  Massachusetts,  01730,  United States; Recruiting

Study ID Numbers:  IIR 99-241
Record last reviewed:  October 2000
Record first received:  March 14, 2001
ClinicalTrials.gov Identifier:  NCT00012818
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09