|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | October 31, 2008 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00012818 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Cost Effectiveness of Relaxation and Response to CHF | ||||
| Official Title ICMJE | Efficacy and Cost Effectiveness of Relaxation and Response to CHF | ||||
| 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. |
||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Chronic Heart Failure | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Completion Date | September 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: CHF diagnosis, NY stage 2 or 3 Exclusion Criteria: |
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00012818 | ||||
| Responsible Party | Hendricks, Ann - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | IIR 99-241 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | July 2005 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||