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Telephone Intervention in Heart Failure Patients

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ClinicalTrials.gov Identifier: NCT00057057
Recruitment Status : Completed
First Posted : March 28, 2003
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment
Heart Failure, Congestive Cardiomyopathy 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of a Telephone Intervention in Heart Failure Patients
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Arm 1 Behavioral: Telephone Care




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057057


Locations
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Mark E. Dunlap, MD Louis Stokes VA Medical Center, Cleveland, OH

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00057057     History of Changes
Other Study ID Numbers: CHI 99-074
First Posted: March 28, 2003    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: February 2007

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases