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

Study Overview
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Brief Summary
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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.

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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: Tele-health Monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>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<br>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<br>* Daily tele-health monitoring data will be collected from randomized participants.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congestive heart failure, systolic, chronic disease, heart failure