CHF Management Using Telemedicine

Congestive Heart Failure (CHF) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309764
• Other study ID #: Project # 041873
• Status: Completed
• Phase: N/A
• First received: March 31, 2006
• Last updated: March 31, 2006
• Start date: November 2001
• Est. completion date: August 2002

Study information

• Verified date: March 2006
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Physician diagnosed CHF

• Member of Kaiser Permanente Georgia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure (CHF)
• Heart Failure

Intervention

Behavioral:
• Telemedicine

Locations

Country	Name	City	State
United States	Kaiser Permanente - Georgia	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Knowledge of signs of worsening CHF (sudden weight gain, increase in shortness of breath)
Primary	Quality of life
Secondary	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.