Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1KL2RR024990 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Honeywell HomMed Telemonitor | Active Comparator | TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure. |
|
| Usual care | No Intervention | These participants receive usual care which consists of usual home-care with educational package. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honeywell HomMed Telemonitor | Device | telemonitoring post hospitalization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Participants were followed for the duration of home care services up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Kansas City Cardiomyopathy Questionaire | Health Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome | Participants were followed for the duration of home care services up to 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Boxer, MD | Case Western Reserve Univeristy | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Honeywell HomMed Telemonitor | TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure. |
| FG001 | Usual Care | Usual care which consists of usual home-care with educational package. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Standard Deviation | Days | Participants were followed for the duration of home care services up to 12 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Compliance Officer | Case Western Reserve University | 216-368-0134 | kav6@case.edu |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Usual care which consists of usual home-care with educational package.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Kansas City Cardiomyopathy Questionaire | Health Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome | Posted | Mean | Standard Deviation | score on a scale | Participants were followed for the duration of home care services up to 12 months |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Usual Care | Usual care which consists of usual home-care with educational package. | 0 | 45 | 0 | 45 |
Not provided
Not provided