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Louisiana State University Health Care Sciences Division (LSU HSCD) Tele-Health Projects: Adult CHF Patient Population

Not Applicable
Completed
Conditions
Congestive Heart Failure
Interventions
Device: Tele-health Monitoring
Registration Number
NCT01148563
Lead Sponsor
Pennington Biomedical Research Center
Brief Summary

The purpose of this research study is to see whether a tele-health intervention can improve health, functioning status, emotional status, quality of life, and patient satisfaction for patients with Congestive Heart Failure (CHF) and to examine the cost benefits of this intervention.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
136
Inclusion Criteria
  • equal to or greater than 18 years old
  • 1 + past CHF diagnosis in LSU database, with history of CHF diagnosis extending back for 12 months
  • LSU primary care or chronic disease clinic patient for equal or greater than 6 months.
  • On CHF medication for equal to or greater than 6 months
  • Have had a past echocardiogram
  • Mental competency to consent and participate (determined by clinical judgment and chart abstraction)
  • Physically able to use in-home equipment (or presence of a household member who can assist the subject in equipment use)
  • Currently-working conventional telephone line at primary residence
  • Grounded electrical power supply at primary residence
  • Anticipation of remaining in the LSU HCSD patient population for the next year
  • Not on home oxygen therapy
  • No planned surgery within the next six months
  • Living at home (not institutionalized)
  • No history of major organ transplant
  • No diagnosis of metastatic or inoperable cancer
  • Not under treatment for cancer
  • Not under treatment for end-stage renal disease or end-stage liver disease
  • 1 + emergency department visit or inpatient stay in past 12 months
Exclusion Criteria
  • Are on home oxygen
  • Have a planned surgery within the next 6 months
  • Have a history of major organ transplant
  • Have a diagnosis of metastatic or inoperable cancer
  • Are under treatment for cancer
  • Are under treatment for end-stage renal disease or end-stage liver disease
  • Have HIV/AIDS
  • Have a cognitive condition, such as Alzheimer's or dementia that would make it difficult for you to understand how to use the tele-health device.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Tele-health Monitoring GroupTele-health MonitoringThe tele-monitoring intervention group will have the continual standard care from their physician plus the tele-health monitoring. The tele-health monitor will collect the following data: weight, blood pressure, pulse oximetry, pulse rate, \& patient responses to disease-specific questions regarding changes in state of health for 6 months.
Primary Outcome Measures
NameTimeMethod
Events Per Person-year12 months

(Number of emergency department visits + number of inpatient stays) / person-year

Secondary Outcome Measures
NameTimeMethod
U.S. Dollars Per Person-year12 months

(emergency department costs + inpatient costs) / person-year

Trial Locations

Locations (4)

Earl K. Long Medical Center

🇺🇸

Baton Rouge, Louisiana, United States

Leonard J. Chabert Medical Center

🇺🇸

Houma, Louisiana, United States

WO Moss Regional Medical Center

🇺🇸

Lake Charles, Louisiana, United States

University Medical Center

🇺🇸

Lafayette, Louisiana, United States

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