Clinical trial NCT00309764: CHF Management Using Telemedicine
Official title: Improving CHF Outcomes Through Interactive Voice Recognition (IVR) Data Acquisition and Targeted Nurse Follow-Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure (CHF)
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2006-04-03
Enrollment: 106
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

Eligibility criteria: Inclusion Criteria:

* Physician diagnosed CHF
* Member of Kaiser Permanente Georgia

Primary outcomes:
measure: 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)
measure: Knowledge of signs of worsening CHF (sudden weight gain, increase in shortness of breath)
measure: Quality of life
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente - Georgia
state: Georgia
Study officials:
affiliation: Kaiser Permanente - Georgia Region
name: Douglas Roblin, PhD
role: PRINCIPAL_INVESTIGATOR
References: