ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Telephone Intervention in Heart Failure Patients

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00057057
  Purpose

In addition to medical treatment for heart failure (HF), a variety of non-pharmacological interventions have been demonstrated to benefit these patients. Some of these include systems for weight monitoring and medication reminders, exercise programs, and individually tailored evaluation and treatment plans with dietitians, social workers, psychologists, and nurse case managers. While many of these approaches have been shown to increase adherence to medication guidelines and result in decreased health care utilization, most rely heavily on a large team of specialized health care providers. It remains unknown whether or not an intervention with a lower intensity of specialized care using sophisticated automated computer tracking and Interactive Voice Response (IVR) techniques can impact the care of HF patients.


Condition Intervention
Heart Failure, Congestive
Cardiomyopathy
Behavioral: Telephone Care

MedlinePlus related topics:   Cardiomyopathy    Heart Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Randomized Trial of a Telephone Intervention in Heart Failure Patients

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:   438
Study Completion Date:   March 2005

Arms Assigned Interventions
1 Behavioral: Telephone Care

Detailed Description:

Background:

In addition to medical treatment for heart failure (HF), a variety of non-pharmacological interventions have been demonstrated to benefit these patients. Some of these include systems for weight monitoring and medication reminders, exercise programs, and individually tailored evaluation and treatment plans with dietitians, social workers, psychologists, and nurse case managers. While many of these approaches have been shown to increase adherence to medication guidelines and result in decreased health care utilization, most rely heavily on a large team of specialized health care providers. It remains unknown whether or not an intervention with a lower intensity of specialized care using sophisticated automated computer tracking and Interactive Voice Response (IVR) techniques can impact the care of HF patients.

Objectives:

The primary hypothesis of this study is that Heart Failure Telephone Intervention (HearT-I) will decrease hospitalizations and clinic visits in the veteran population with heart failure.

Methods:

The HearT-I intervention consists of three components: 1) computer-initiated medication refill and clinic appointment reminders; 2) IVR access to educational modules; and 3) weekly computer-initiated phone calls with a series of questions regarding weight and symptoms. Four hundred eighty-eight HF patients (NYHA class II-IV) will be randomized to HearT-I intervention vs. usual care. Upon enrollment, all patients will complete questionnaires assessing HF knowledge, behavior, self-efficacy, and perceptions of HF health care, and HF related Quality of Life (Kansas City Cardiomyopathy Questionnaire, KCCQ). Both groups also will receive a digital scale, educational materials, view an educational video about HF and perform a six-minute walk test. We will test the hypothesis that the HearT-I intervention will decrease health care utilization as measured by hospitalizations and unscheduled outpatient visits for HF over one year. Secondary endpoints include KCCQ score, patient satisfaction, adherence to medications, and general knowledge of heart failure and its management.

Status:

Preliminary data analyisis has begun.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Heart failure NYMA class 2-4, HX of heart failure hospitalization, No COPD, Kansas City Cardiac Questionnaire (Quality of Life)=31-80, 6 minute walk test <450

Exclusion Criteria:

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057057

Locations
United States, Ohio
Louis Stokes VA Medical Center    
      Cleveland, Ohio, United States, 44106-3800

Sponsors and Collaborators

Investigators
Principal Investigator:     Mark E. Dunlap, MD     Louis Stokes VA Medical Center    
  More Information


Responsible Party:   Department of Veterans Affairs ( Dunlap, Mark - Principal Investigator )
Study ID Numbers:   CHI 99-074
First Received:   March 27, 2003
Last Updated:   October 31, 2008
ClinicalTrials.gov Identifier:   NCT00057057
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Cardiomyopathies

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers