Congestive Heart Failure
Conditions
Keywords
congestive heart failure, systolic, chronic disease, heart failure
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.
Interventions
DEVICETele-health Monitoring
Daily tele-health monitoring data will be collected from randomized participants.
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Events Per Person-year | 12 months | (Number of emergency department visits + number of inpatient stays) / person-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| U.S. Dollars Per Person-year | 12 months | (emergency department costs + inpatient costs) / person-year |
Countries
United States
Participant flow
Recruitment details
Subjects were nested within LSU HCSD clinics. Potential subjects were approved by their physicians for inclusion in addition to meeting the stated inclusion criteria. Study recruiters contacted the potentially-eligible subjects at the times of their next scheduled clinic visits. Recruitment Period: 3/9/09-8/31/10.
Pre-assignment details
Of the original 137 subjects recruited, one subject in the treatment group withdrew from the study prior to having home monitoring equipment installed, leaving a total of 136 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Standard Care The Standard Care group will continue regular LSU HCSD disease management care for heart failure patients with no additional intervention. | 69 |
| 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. | 67 |
| Total | 136 |
Baseline characteristics
| Characteristic | Tele-health Monitoring Group | Standard Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 17 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 52 Participants | 106 Participants |
| Age, Continuous | 56.641791 years STANDARD_DEVIATION 10.08855 | 57.623188 years STANDARD_DEVIATION 9.2801202 | 57.139706 years STANDARD_DEVIATION 9.6633502 |
| Region of Enrollment United States | 67 participants | 69 participants | 136 participants |
| Sex: Female, Male Female | 29 Participants | 40 Participants | 69 Participants |
| Sex: Female, Male Male | 38 Participants | 29 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 67 |
| serious Total, serious adverse events | 40 / 69 | 31 / 67 |
Outcome results
Primary
Events Per Person-year
(Number of emergency department visits + number of inpatient stays) / person-year
Time frame: 12 months
Population: Used an Intention to Treat (ITT) Analysis. Missing outcome data were imputed as necessary.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Care | Events Per Person-year | 84 events/person-year |
| Tele-health Monitoring Group | Events Per Person-year | 57 events/person-year |
p-value: 0.09495% CI: [-0.65, 0.05]bootstrapping
Secondary
U.S. Dollars Per Person-year
(emergency department costs + inpatient costs) / person-year
Time frame: 12 months
Population: All heart failure patients included in the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | U.S. Dollars Per Person-year | 10363 U.S. dollars per person-year | Standard Error 1630 |
| Tele-health Monitoring Group | U.S. Dollars Per Person-year | 7212 U.S. dollars per person-year | Standard Error 279 |
p-value: 0.10595% CI: [0.45, 1.08]bootstrapping