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

LSU HCSD Tele-Health Projects: Adult Systolic Heart Failure Patient Population

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Device: Tele-health Monitoring

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70805
      • Earl K. Long Medical Center
    • Houma, Louisiana, United States, 70363
      • Leonard J. Chabert Medical Center
    • Lafayette, Louisiana, United States, 70506
      • University Medical Center
    • Lake Charles, Louisiana, United States, 70607
      • WO Moss Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
Active Comparator: Tele-health Monitoring Group; The 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.	Device: Tele-health Monitoring; Daily tele-health monitoring data will be collected from randomized participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Events Per Person-year	(Number of emergency department visits + number of inpatient stays) / person-year	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
U.S. Dollars Per Person-year	(emergency department costs + inpatient costs) / person-year	12 months

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Louisiana State University Health Care Services Division
• Investigators: Principal Investigator: Lee Arcement, MD, Louisiana State University Health Care Services Division; Study Chair: Michael Kaiser, MD, Louisiana State University Health Care Services Division; Study Chair: Ronald Horswell, PhD, Louisiana State University Health Care Services Division; Study Chair: Jay Besse, BS, Louisiana State University Health Care Services Divison; Study Chair: Timothy S. Church, MD, MPH, PhD, Pennington Biomedical Research Center; Study Chair: Valerie H. Myers, PhD, Pennington Biomedical Research Center; Study Chair: Donna H. Ryan, MD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: June 18, 2010
• First Submitted That Met QC Criteria: June 18, 2010
• First Posted (Estimated): June 22, 2010

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: heart failure; chronic disease; systolic; congestive heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PBRC 29003