CHF Management Using Telemedicine

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00309764
First received: March 31, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

The overall objective of this study is to improve clinical outcomes and quality of life for congestive heart failure (CHF) patients by integrating a readily available, low cost technology – the telephone – into coordinated CHF care.


Condition Intervention
Congestive Heart Failure (CHF)
Behavioral: Telemedicine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving CHF Outcomes Through Interactive Voice Recognition (IVR) Data Acquisition and Targeted Nurse Follow-Up

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Change between study entry and exit (6-months later) in frequency of recommended CHF self-care practices (maintain CHF diary, check weight daily, check ankles and feet for swelling daily)
  • Knowledge of signs of worsening CHF (sudden weight gain, increase in shortness of breath)
  • Quality of life

Secondary Outcome Measures:
  • Rate of acute CHF exacerbations (ED visits or hospital admissions for CHF or CHF-related conditions) in the 6-month intervention period compared with the 6-month period preceding study entry.

Estimated Enrollment: 106
Study Start Date: November 2001
Estimated Study Completion Date: August 2002
Detailed Description:

Strong patient-provider communication and vigilant home-based monitoring can be critical elements of successful chronic disease management. Among CHF patients, automated clinical data acquisition via the telephone can improve insight into inappropriate use of medications and onset of fluid overload or edema – indicating deteriorating heart function (notably worsening ejection fraction). Routine, timely monitoring of this data can direct a nurse case manager to the subset of CHF patients likely to benefit from a clinic visit, evaluation, diagnosis, and counseling. This should result in: significantly increased medication compliance, significantly lower emergency department (ED) visits and hospital admissions (both those related to CHF and other conditions related to diminished physical capacity of patients with CHF), and improved physical function.

This study is intended to answer three questions. First, do potentially avoidable acute events (measured by ED visits and hospital admissions) decrease when CHF management is accompanied by systematic telephone-based monitoring as compared with usual care? Second, does medication compliance improve when CHF management is accompanied by systematic telephone-based monitoring as compared with usual care? Third, does perceived health status (physical and emotional function) improve when CHF management is accompanied by systematic telephone-based monitoring as compared with usual care?

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Physician diagnosed CHF
  • Member of Kaiser Permanente Georgia
  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: NCT00309764

Locations
United States, Georgia
Kaiser Permanente - Georgia
Atlanta, Georgia, United States, 30305
Sponsors and Collaborators
Kaiser Permanente
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Douglas Roblin, PhD Kaiser Permanente - Georgia Region
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00309764     History of Changes
Other Study ID Numbers: Project # 041873
Study First Received: March 31, 2006
Last Updated: March 31, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014