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CHF Management Using Telemedicine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309764
First Posted: April 3, 2006
Last Update Posted: April 3, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Robert Wood Johnson Foundation
Information provided by:
Kaiser Permanente
March 31, 2006
April 3, 2006
April 3, 2006
November 2001
Not Provided
  • 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
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
CHF Management Using Telemedicine
Improving CHF Outcomes Through Interactive Voice Recognition (IVR) Data Acquisition and Targeted Nurse Follow-Up
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.

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?

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Congestive Heart Failure (CHF)
Behavioral: Telemedicine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
August 2002
Not Provided

Inclusion Criteria:

  • Physician diagnosed CHF
  • Member of Kaiser Permanente Georgia
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00309764
Project # 041873
Not Provided
Not Provided
Not Provided
Not Provided
Kaiser Permanente
Robert Wood Johnson Foundation
Principal Investigator: Douglas Roblin, PhD Kaiser Permanente - Georgia Region
Kaiser Permanente
March 2006

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