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Completed

NCT Number: NCT01148563

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Earl K. Long Medical Center, Baton Rouge, Louisiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tele-health Monitoring

Device

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

Primary outcomes

  1. Events Per Person-year

    Time frame: 12 months

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

Secondary outcomes

  1. U.S. Dollars Per Person-year

    Time frame: 12 months

    (emergency department costs + inpatient costs) / person-year

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

LSU HCSD Tele-Health Projects: Adult Systolic Heart Failure Patient Population

Acronym: TeleHealth:CHF

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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