Trial Outcomes & Findings for A Trial of Telemonitoring in Adults With Heart Failure (NCT NCT01393314)
NCT ID: NCT01393314
Last Updated: 2022-08-10
Results Overview
Median time to combined endpoint to see if/when the participants need to be readmitted to the hospital or visit the ED
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Participants were followed for the duration of home care services up to 12 months
Results posted on
2022-08-10
Participant Flow
Participant milestones
| Measure |
Honeywell HomMed Telemonitor
TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure.
|
Usual Care
Usual care which consists of usual home-care with educational package.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
45
|
|
Overall Study
COMPLETED
|
54
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Telemonitoring in Adults With Heart Failure
Baseline characteristics by cohort
| Measure |
Honeywell HomMed Telemonitor
n=54 Participants
TeleCareOhio Monitor (Honeywell HomeMed) system provides in-home medical monitoring for patients with chronic disease such as heart failure; telemonitoring post hospitalization.
|
Usual Care
n=45 Participants
Usual care which consists of usual home-care with educational package.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
74.7 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
74.85 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of home care services up to 12 monthsMedian time to combined endpoint to see if/when the participants need to be readmitted to the hospital or visit the ED
Outcome measures
| Measure |
Honeywell HomMed Telemonitor
n=54 Participants
Honeywell HomMed Telemonitor: telemonitoring post hospitalization
|
Usual Care
n=45 Participants
This participants receive usual care which consists of usual home-care with educational package.
|
|---|---|---|
|
The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED).
|
60 Days
Standard Deviation 3
|
62 Days
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Participants were followed for the duration of home care services up to 12 monthsHealth Status, Change in Overall Summary Score minimum: 0 maximum: 100 higher scores=better outcome
Outcome measures
| Measure |
Honeywell HomMed Telemonitor
n=54 Participants
Honeywell HomMed Telemonitor: telemonitoring post hospitalization
|
Usual Care
n=45 Participants
This participants receive usual care which consists of usual home-care with educational package.
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionaire
|
34.3 score on a scale
Standard Deviation 12.9
|
28.3 score on a scale
Standard Deviation 16.85
|
Adverse Events
Honeywell HomMed Telemonitor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Research Compliance Officer
Case Western Reserve University
Phone: 216-368-0134
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place