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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Louisiana State University Health Care Services Division
Leonard J. Chabert Medical Center
University Medical Center
Earl K. Long Medical Center
WO Moss Regional Medical Center
Information provided by (Responsible Party):
Timothy Church, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01148563
First received: June 18, 2010
Last updated: October 28, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention
Congestive Heart Failure
 Device: Tele-health Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: LSU HCSD Tele-Health Projects: Adult Systolic Heart Failure Patient Population

Resource links provided by NLM:

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

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Improve congestive heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The purpose 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).


Secondary Outcome Measures:
  • Cost Benefit [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The secondary outcome is to examine the cost benefits of the tele-health intervention.


Enrollment: 137
Study Start Date: March 2009
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Louisiana State University Health Care Services Division
Leonard J. Chabert Medical Center
University Medical Center
Earl K. Long Medical Center
WO Moss Regional Medical Center
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
  More Information

No publications provided

Responsible Party: Timothy Church, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01148563     History of Changes
Other Study ID Numbers: PBRC29003, R01DK068298
Study First Received: June 18, 2010
Last Updated: October 28, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013