Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012818
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Efficacy and Cost Effectiveness of Relaxation and Response to CHF
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Efficacy and Cost Effectiveness of Relaxation and Response to CHF
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None