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OpenTrials
Completed

NCT Number: NCT00309764

CHF Management Using Telemedicine

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.

Completed

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente - Georgia

Atlanta, Georgia, 30305, United States

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physician diagnosed CHF
  • Member of Kaiser Permanente Georgia

Treatment and study plan

Telemedicine

Behavioral

Primary outcomes

  1. 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)

  2. Knowledge of signs of worsening CHF (sudden weight gain, increase in shortness of breath)

  3. Quality of life

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Official study title

Improving CHF Outcomes Through Interactive Voice Recognition (IVR) Data Acquisition and Targeted Nurse Follow-Up

Important dates

Study start
2001
Study completion
2002
First posted
Apr 3, 2006
Registry last updated
Apr 3, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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