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

NCT ID: NCT01148563

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Tele-health Monitoring

Intervention Type: DEVICE

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

Interventions

Tele-health Monitoring

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Arcement, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Care Services Division

Michael Kaiser, MD

Role: STUDY_CHAIR

Louisiana State University Health Care Services Division

Ronald Horswell, PhD

Role: STUDY_CHAIR

Louisiana State University Health Care Services Division

Jay Besse, BS

Role: STUDY_CHAIR

Louisiana State University Health Care Services Divison

Timothy S. Church, MD, MPH, PhD

Role: STUDY_CHAIR

Pennington Biomedical Research Center

Valerie H. Myers, PhD

Role: STUDY_CHAIR

Pennington Biomedical Research Center

Donna H. Ryan, MD

Role: STUDY_CHAIR

Pennington Biomedical Research Center

Locations

Earl K. Long Medical Center

Baton Rouge, Louisiana, United States

Leonard J. Chabert Medical Center

Houma, Louisiana, United States

University Medical Center

Lafayette, Louisiana, United States

WO Moss Regional Medical Center

Lake Charles, Louisiana, United States

Countries

United States

Other Identifiers

PBRC 29003

Identifier Type: -

Identifier Source: org_study_id