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Home > "E" Clinical Trials Conditions > Efficacy and Cost Effectiveness of Relaxation and Response to CHF  Efficacy and Cost Effectiveness of Relaxation and Response to CHF
Efficacy and Cost Effectiveness of Relaxation and Response to CHF
For Condition: Heart Failure, Congestive
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Health Services Research and Development Service
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Ambulatory CHF patients who receive health care at the Boston and West Roxbury VA medical centers.
Total Enrollment: 120
Location and Contact Information:
Edith Nourse Rogers Memoral Veterans Hospital *Recruiting*
Bedford, Massachusetts, 01730
United States
Recruiting Bei-Hung Chang 781-275-7500
Edith Nourse Rogers Memoral Veterans Hospital *Recruiting*
Bedford, Massachusetts, 01730
United States
Recruiting Ann Hendricks 781-687-2963
Additional Information:
Study ID Numbers: IIR 99-241;
Study Start Date: January 2000
Record last reviewed: October 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012818
Other Heart Failure, Congestive Studies:
1. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH)
2. The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure
3. Management of Patients with Congestive Heart Failure After Hospitalization
4. Enoximone Plus Extended-Release Metoprolol Succinate in Subjects with Advanced Chronic Heart Failure
5. Beta-Blocker Evaluation in Survival Trial (BEST)
Related Studies:
Other Heart Failure, Congestive Clinical Trials
Other Massachusetts Clinical Trials
Other Bedford Clinical Trials
Efficacy and Cost Effectiveness of Relaxation and Response to CHF
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