NCT01148563CompletedNot Applicable
LSU HCSD Tele-Health Projects: Adult Systolic Heart Failure Patient Population
Pennington Biomedical Research Center8 sites in 1 country136 target enrollmentStarted: March 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 136
- Locations
- 8
- Primary Endpoint
- Events Per Person-year
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Events Per Person-year
Time Frame: 12 months
(Number of emergency department visits + number of inpatient stays) / person-year
Secondary Outcomes
- U.S. Dollars Per Person-year(12 months)
Investigators
Study Sites (8)
Loading locations...
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