N/A
N=136
Louisiana State University Health Care Sciences Division (LSU HSCD) Tele-Health Projects: Adult CHF Patient Population
Congestive Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01148563 ↗Enrolled (actual)
136
Serious AEs
52.2%
Results posted
Dec 2017
Primary outcome: Primary: Events Per Person-year — 84; 57 events/person-year — p=0.094
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tele-health Monitoring (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Events Per Person-year |
84; 57 | 0.094 |
| SECONDARY U.S. Dollars Per Person-year |
10363; 7212 | 0.105 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01148563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.