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

Pennington Biomedical Research Center

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Device: Tele-health Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01148563

PBRC 29003

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Standard Care

No Intervention group

Description:

The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.

Tele-health Monitoring Group

Active Comparator group

Description:

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.

Treatment:

Device: Tele-health Monitoring