Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Trial of a Tailored Message Program to Implement CHF Guidelines

This study has been completed.
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013026
First received: March 14, 2001
Last updated: April 15, 2014
Last verified: April 2014

March 14, 2001
April 15, 2014
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00013026 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial of a Tailored Message Program to Implement CHF Guidelines
Trial of a Tailored Message Program to Implement CHF Guidelines

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Heart Failure
Behavioral: CHF Self-management Education (Web-based Education)
Arm 1
Intervention: Behavioral: CHF Self-management Education (Web-based Education)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
March 2004
Not Provided

Inclusion Criteria:

EF <40%, getting majority care at the VA, not enrolled in another CHF study, ability to read English.

Exclusion Criteria:

Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00013026
CPI 99-124
No
Department of Veterans Affairs
Department of Veterans Affairs
Indiana University School of Medicine
Principal Investigator: Terrence M. Shaneyfelt, MPH MD Department of Veterans Affairs
Principal Investigator: Catarina I. Kiefe, PhD MD Brimingham VA Medical Center
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP