Clinical trial NCT01148563: Louisiana State University Health Care Sciences Division (LSU HSCD) Tele-Health Projects: Adult CHF Patient Population
Official title: LSU HCSD Tele-Health Projects: Adult Systolic Heart Failure Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: congestive heart failure
systolic
chronic disease
heart failure
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Events Per Person-year
timeFrame: 12 months
Secondary outcomes:
measure: U.S. Dollars Per Person-year
timeFrame: 12 months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Earl K. Long Medical Center
state: Louisiana
city: Houma
country: United States
facility: Leonard J. Chabert Medical Center
state: Louisiana
city: Lafayette
country: United States
facility: University Medical Center
state: Louisiana
city: Lake Charles
country: United States
facility: WO Moss Regional Medical Center
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Care Services Division
name: Lee Arcement, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louisiana State University Health Care Services Division
name: Michael Kaiser, MD
role: STUDY_CHAIR
affiliation: Louisiana State University Health Care Services Division
name: Ronald Horswell, PhD
role: STUDY_CHAIR
affiliation: Louisiana State University Health Care Services Divison
name: Jay Besse, BS
role: STUDY_CHAIR
affiliation: Pennington Biomedical Research Center
name: Timothy S. Church, MD, MPH, PhD
role: STUDY_CHAIR
affiliation: Pennington Biomedical Research Center
name: Valerie H. Myers, PhD
role: STUDY_CHAIR
affiliation: Pennington Biomedical Research Center
name: Donna H. Ryan, MD
role: STUDY_CHAIR
References: