Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | March 14, 2001 | ||||
Last Updated Date | January 30, 2009 | ||||
Start Date † | |||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00013026 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Trial of a Tailored Message Program to Implement CHF Guidelines | ||||
Official Title † | Trial of a Tailored Message Program to Implement CHF Guidelines | ||||
Brief Summary | Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial. |
||||
Detailed Description | Background: Congestive heart failure is a serious health problem in the United States and is associated with excessive morbidity and mortality. Several classes of medications have been shown to improve mortality in patients with CHF. Despite this these medications are widely under prescribed. Guidelines have been shown to improve patient outcomes and several guidelines on the management of CHF have been published. Implementation of guidelines is challenging and most strategies have focused on changing physician behavior. Patient-based interventions have been shown to be effective in implementing guidelines on CHF but they have been very labor intensive. A computer based intervention to implement CHF guidelines, if effective, would be beneficial. Objectives: Patients with CHF consume a significant proportion of healthcare resources, with exacerbations of CHF being the second most common reason for medical admission to VA medical centers. Therefore, the main objective is to understand the impact of a tailored education message program designed for direct use by patients on medical resource use. Other objectives include understanding the tools impact on patient compliance and quality of life. Methods: Patients have been randomized to one of two groups: 1) intervention group or the 2) control group. The intervention group receives the tailored education messages program. This program assesses patients� beliefs about compliance with medications, diet, and self-monitoring. Based on identified barriers to compliance, intervention patients receive a tailored educational message to dispel these beliefs and improve compliance. The control group interacts with a generic healthcare website. Patients in both groups are monitored for hospitalization; emergent care visits, compliance with prescribed treatment and quality of life Status: Project work is ongoing. |
||||
Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Other, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Heart Failure | ||||
Intervention † | Behavioral: CHF Self-management Education (Web-based Education) | ||||
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 † | Completed | ||||
Enrollment † | 700 | ||||
Completion Date | March 2004 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria: EF <40%, getting majority care at the VA, not enrolled in another CHF study, ability to read English. Exclusion Criteria: |
||||
Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00013026 | ||||
Responsible Party | Shaneyfelt, Terrence - Principal Investigator, Department of Veterans Affairs | ||||
Secondary IDs †† | |||||
Study Sponsor † | Department of Veterans Affairs | ||||
Collaborators †† | Indiana University School of Medicine | ||||
Investigators † |
|
||||
Information Provided By | Department of Veterans Affairs | ||||
Verification Date | July 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |