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

• ClinicalTrials.gov Identifier: NCT01148563
• Recruitment Status: Completed
• First Posted: June 22, 2010
• Results First Posted: December 19, 2017
• Last Update Posted: May 14, 2018
• Sponsor: Pennington Biomedical Research Center
• Collaborator: Louisiana State University Health Care Services Division
• Information provided by (Responsible Party): Ronald Horswel, Pennington Biomedical Research Center

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Events Per Person-year [ Time Frame: 12 months ]
   (Number of emergency department visits + number of inpatient stays) / person-year

Secondary Outcome Measures :

1. U.S. Dollars Per Person-year [ Time Frame: 12 months ]
   (emergency department costs + inpatient costs) / person-year

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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.

Contacts and Locations

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

More Information

• Responsible Party: Ronald Horswel, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT01148563
• Other Study ID Numbers: PBRC 29003
• First Posted: June 22, 2010
• Results First Posted: December 19, 2017
• Last Update Posted: May 14, 2018
• Last Verified: April 2018

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