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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-health Monitoring
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Congestive Heart Failure focused on measuring congestive heart failure, systolic, chronic disease, heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Earl K. Long Medical Center
  • Leonard J. Chabert Medical Center
  • University Medical Center
  • WO Moss Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Care

Tele-health Monitoring Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Events Per Person-year
(Number of emergency department visits + number of inpatient stays) / person-year

Secondary Outcome Measures

U.S. Dollars Per Person-year
(emergency department costs + inpatient costs) / person-year

Full Information

First Posted
June 18, 2010
Last Updated
April 11, 2018
Sponsor
Pennington Biomedical Research Center
Collaborators
Louisiana State University Health Care Services Division
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1. Study Identification

Unique Protocol Identification Number
NCT01148563
Brief Title
Louisiana State University Health Care Sciences Division (LSU HSCD) Tele-Health Projects: Adult CHF Patient Population
Acronym
TeleHealth:CHF
Official Title
LSU HCSD Tele-Health Projects: Adult Systolic Heart Failure Patient Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Louisiana State University Health Care Services Division

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
congestive heart failure, systolic, chronic disease, heart failure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention.
Arm Title
Tele-health Monitoring Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Tele-health Monitoring
Intervention Description
Daily tele-health monitoring data will be collected from randomized participants.
Primary Outcome Measure Information:
Title
Events Per Person-year
Description
(Number of emergency department visits + number of inpatient stays) / person-year
Time Frame
12 months
Secondary Outcome Measure Information:
Title
U.S. Dollars Per Person-year
Description
(emergency department costs + inpatient costs) / person-year
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Arcement, MD
Organizational Affiliation
Louisiana State University Health Care Services Division
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Kaiser, MD
Organizational Affiliation
Louisiana State University Health Care Services Division
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ronald Horswell, PhD
Organizational Affiliation
Louisiana State University Health Care Services Division
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jay Besse, BS
Organizational Affiliation
Louisiana State University Health Care Services Divison
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Timothy S. Church, MD, MPH, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Valerie H. Myers, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Donna H. Ryan, MD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Earl K. Long Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70805
Country
United States
Facility Name
Leonard J. Chabert Medical Center
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70363
Country
United States
Facility Name
University Medical Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
WO Moss Regional Medical Center
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70607
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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