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
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: CHF Self-management Education (Web-based Education)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Trial of a Tailored Message Program to Implement CHF Guidelines

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 700
Study Completion Date: March 2004
Arms Assigned Interventions
Arm 1 Behavioral: CHF Self-management Education (Web-based Education)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013026

Locations
United States, Alabama
Brimingham VA Medical Center
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Terrence M. Shaneyfelt, MPH MD Department of Veterans Affairs
Principal Investigator: Catarina I. Kiefe, PhD MD Brimingham VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013026     History of Changes
Other Study ID Numbers: CPI 99-124
Study First Received: March 14, 2001
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Congestive Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014