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

NCT01148563 | Completed Results DMC

• 1 other identifier: PBRC 29003
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 4

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.

Conditions

Congestive Heart Failure

Keywords

congestive heart failure; systolic; chronic disease; heart failure

Outcome Measures

Primary Outcomes (1)

• Events Per Person-year

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

  12 months

Secondary Outcomes (1)

• U.S. Dollars Per Person-year

  12 months

Study Arms (2)

Standard Care

NO INTERVENTION

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

Tele-health Monitoring Group

ACTIVE COMPARATOR

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

Interventions

Tele-health Monitoring DEVICE

Daily tele-health monitoring data will be collected from randomized participants.

Tele-health Monitoring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• equal to or greater than 18 years old
• + 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (4)

Earl K. Long Medical Center

Baton Rouge, Louisiana, 70805, United States

Location

Leonard J. Chabert Medical Center

Houma, Louisiana, 70363, United States

Location

University Medical Center

Lafayette, Louisiana, 70506, United States

Location

WO Moss Regional Medical Center

Lake Charles, Louisiana, 70607, United States

Location

MeSH Terms

Conditions

Heart Failure; Systolic Murmurs; Chronic Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Murmurs; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Dr. Ron Horswell
• Organization: Louisiana State Univeristy Health Care Services Division

rhorsw@lsuhsc.edu

225-763-2983

Study Officials

• Lee Arcement, MD

  Louisiana State University Health Care Services Division

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 22, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: January 25, 2024
• Results First Posted: December 19, 2017

Record last verified: 2024-01

Locations

US (4)