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

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ClinicalTrials.gov Identifier: NCT01148563
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Louisiana State University Health Care Services Division
Information provided by (Responsible Party):
Ronald Horswel, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: Tele-health Monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: LSU HCSD Tele-Health Projects: Adult Systolic Heart Failure Patient Population
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Standard Care
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
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
Daily tele-health monitoring data will be collected from randomized participants.



Primary Outcome Measures :
  1. Events Per Person-year [ Time Frame: 6 months ]
    (Number of emergency department visits + number of inpatient stays) / person-year


Secondary Outcome Measures :
  1. Cost Per Person-year [ Time Frame: 12 months ]
    (emergency department costs + inpatient costs) / person-year



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148563


Locations
United States, Louisiana
Earl K. Long Medical Center
Baton Rouge, Louisiana, United States, 70805
Leonard J. Chabert Medical Center
Houma, Louisiana, United States, 70363
University Medical Center
Lafayette, Louisiana, United States, 70506
WO Moss Regional Medical Center
Lake Charles, Louisiana, United States, 70607
Sponsors and Collaborators
Pennington Biomedical Research Center
Louisiana State University Health Care Services Division
Investigators
Principal Investigator: Lee Arcement, MD Louisiana State University Health Care Services Division
Study Chair: Michael Kaiser, MD Louisiana State University Health Care Services Division
Study Chair: Ronald Horswell, PhD Louisiana State University Health Care Services Division
Study Chair: Jay Besse, BS Louisiana State University Health Care Services Divison
Study Chair: Timothy S. Church, MD, MPH, PhD Pennington Biomedical Research Center
Study Chair: Valerie H. Myers, PhD Pennington Biomedical Research Center
Study Chair: Donna H. Ryan, MD Pennington Biomedical Research Center

Responsible Party: Ronald Horswel, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01148563     History of Changes
Other Study ID Numbers: PBRC 29003
First Posted: June 22, 2010    Key Record Dates
Results First Posted: December 19, 2017
Last Update Posted: December 19, 2017
Last Verified: November 2017

Keywords provided by Ronald Horswel, Pennington Biomedical Research Center:
congestive heart failure
systolic
chronic disease
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases