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

Congestive Heart Failure Clinical Trial

— TeleHealth:CHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148563
• Other study ID #: PBRC 29003
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: April 2011

Study information

• Verified date: January 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Tele-health Monitoring
Daily tele-health monitoring data will be collected from randomized participants.

Locations

Country	Name	City	State
United States	Earl K. Long Medical Center	Baton Rouge	Louisiana
United States	Leonard J. Chabert Medical Center	Houma	Louisiana
United States	University Medical Center	Lafayette	Louisiana
United States	WO Moss Regional Medical Center	Lake Charles	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Events Per Person-year	(Number of emergency department visits + number of inpatient stays) / person-year	12 months
Secondary	U.S. Dollars Per Person-year	(emergency department costs + inpatient costs) / person-year	12 months