Heart Failure
Conditions
Brief summary
This is a randomized controlled trial of telemonitoring vs usual care provided by home care agencies for patients with heart failure. The study hypothesis is that Telemonitoring will reduce hospital re-admission rates, urgent care visits, unscheduled physician appointments, Emergency Room visits in patients with heart failure over the 60 day post hospitalization period.
Detailed description
A 60 day stratified, randomized clinical trial of a home-based telemonitoring system (TEP) vs. usual home-care with educational package (EP). Both Groups will receive intensive patient education and primary care physicians will be prompted to adhere to heart failure management guidelines. The study will be conducted on 100 patients receiving home care nursing services post-hospital discharge. Each participant will be randomized in equal amounts to treatment (TEP) or no treatment (EP).
Interventions
DEVICEHoneywell HomMed Telemonitor
telemonitoring post hospitalization
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Heart Failure (primary or secondary) diagnosis regardless of ejection fraction (EF) and New York Heart Association (NYHA) class II- IV at the time of Home Health Care (HHC) admission and HHC services initiated following a hospital stay
Exclusion criteria
* Inability to stand on a scale, weight over 500 pounds, unable to hear and/or see, or no working land line phone in the residence. * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED). | Participants were followed for the duration of home care services up to 12 months | Median time to combined endpoint to see if/when the participants need to be readmitted to the hospital or visit the ED |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kansas City Cardiomyopathy Questionaire | Participants were followed for the duration of home care services up to 12 months | Health Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Honeywell HomMed Telemonitor TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure; telemonitoring post hospitalization. | 54 |
| Usual Care Usual care which consists of usual home-care with educational package. | 45 |
| Total | 99 |
Baseline characteristics
| Characteristic | Usual Care | Total | Honeywell HomMed Telemonitor |
|---|---|---|---|
| Age, Continuous | 74.7 years STANDARD_DEVIATION 11.3 | 74.85 years STANDARD_DEVIATION 11.7 | 75 years STANDARD_DEVIATION 12.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 21 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 78 Participants | 45 Participants |
| Sex: Female, Male Female | 27 Participants | 67 Participants | 40 Participants |
| Sex: Female, Male Male | 18 Participants | 32 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 45 |
| serious Total, serious adverse events | 0 / 54 | 0 / 45 |
Outcome results
Primary
The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).
Median time to combined endpoint to see if/when the participants need to be readmitted to the hospital or visit the ED
Time frame: Participants were followed for the duration of home care services up to 12 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Honeywell HomMed Telemonitor | The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED). | 60 Days | Standard Deviation 3 |
| Usual Care | The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED). | 62 Days | Standard Deviation 8.5 |
Secondary
Kansas City Cardiomyopathy Questionaire
Health Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome
Time frame: Participants were followed for the duration of home care services up to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Honeywell HomMed Telemonitor | Kansas City Cardiomyopathy Questionaire | 34.3 score on a scale | Standard Deviation 12.9 |
| Usual Care | Kansas City Cardiomyopathy Questionaire | 28.3 score on a scale | Standard Deviation 16.85 |