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CHF Management Using Telemedicine

Primary Purpose

Congestive Heart Failure (CHF)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure (CHF)

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Physician diagnosed CHF Member of Kaiser Permanente Georgia

Sites / Locations

  • Kaiser Permanente - Georgia

Outcomes

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.

Full Information

First Posted
March 31, 2006
Last Updated
March 31, 2006
Sponsor
Kaiser Permanente
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00309764
Brief Title
CHF Management Using Telemedicine
Official Title
Improving CHF Outcomes Through Interactive Voice Recognition (IVR) Data Acquisition and Targeted Nurse Follow-Up
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kaiser Permanente
Collaborators
Robert Wood Johnson Foundation

4. Oversight

5. Study Description

Brief Summary
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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure (CHF)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Telemedicine
Primary Outcome Measure Information:
Title
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)
Title
Knowledge of signs of worsening CHF (sudden weight gain, increase in shortness of breath)
Title
Quality of life
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physician diagnosed CHF Member of Kaiser Permanente Georgia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Roblin, PhD
Organizational Affiliation
Kaiser Permanente - Georgia Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente - Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30305
Country
United States

12. IPD Sharing Statement

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CHF Management Using Telemedicine

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