Trial Outcomes & Findings for Telehealth Management in HF Disparity Patients (NCT NCT02196922)
NCT ID: NCT02196922
Last Updated: 2017-11-17
Results Overview
Number of hospitalizations during the 90 day observation period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Baseline and Day 90
Results posted on
2017-11-17
Participant Flow
Participant milestones
| Measure |
Comprehensive Outpatient Management (COM-Standard of Care)
Patients in the control group will receive comprehensive outpatient management (COM)at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.
COM: Patients receiving COM experience chronic care management received by disparity patients at a heart failure clinic.
|
Telehealth Self Management (TSM)
Telehealth Self Management (TSM): Experimental: TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
46
|
|
Overall Study
COMPLETED
|
58
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telehealth Management in HF Disparity Patients
Baseline characteristics by cohort
| Measure |
Comprehensive Outpatient Management (COM)
n=58 Participants
Patients in the control group will receive COM at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.
COM: COM experience typical chronic care management received by disparity patients I a heart failure clinic.
|
Telehealth Self Management (TSM)
n=46 Participants
Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
41 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 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
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
46 participants
n=7 Participants
|
104 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 90Population: Intention to treat population (all participants who are randomized to either COM or TSM.
Number of hospitalizations during the 90 day observation period
Outcome measures
| Measure |
Comprehensive Outpatient Management (COM)
n=58 Participants
Patients in the COM group will receive outpatient care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.
COM: Patients receiving COM experience typical chronic care management received by disparity patients at heart failure clinic.
|
Telehealth Self Management (TSM)
n=46 Participants
Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
|
|---|---|---|
|
Hospitalizations
|
.55 participant mean hospitalizations/90 day
Standard Deviation 0.9
|
.78 participant mean hospitalizations/90 day
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Days 0-90Population: Intention to Treat population (all participants to COM or TSM)
Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period
Outcome measures
| Measure |
Comprehensive Outpatient Management (COM)
n=58 Participants
Patients in the COM group will receive outpatient care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.
COM: Patients receiving COM experience typical chronic care management received by disparity patients at heart failure clinic.
|
Telehealth Self Management (TSM)
n=46 Participants
Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
|
|---|---|---|
|
Emergency Department Visits
|
.69 participants group mean ED visits/90 day
Standard Deviation .99
|
.63 participants group mean ED visits/90 day
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Baseline and Day 90Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life)
Outcome measures
| Measure |
Comprehensive Outpatient Management (COM)
n=58 Participants
Patients in the COM group will receive outpatient care at a Heart Failure clinic (primary and cardiac care as reimbursed by Medicaid, Medicare or sliding scale/uncompensated care). COM patients will be contacted on a weekly basis in order to maintain comparable frequency of contact.
COM: Patients receiving COM experience typical chronic care management received by disparity patients at heart failure clinic.
|
Telehealth Self Management (TSM)
n=46 Participants
Telehealth Self Management (TSM): Experimental is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence to the provider station.
|
|---|---|---|
|
Quality of Life
|
27.8 units on a scale
Interval 0.0 to 105.0
|
36.3 units on a scale
Interval 0.0 to 105.0
|
Adverse Events
Comprehensive Outpatient Management (COM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Telehealth Self Management (TSM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Renee Pekmezaris, Ph.D., Vice President Community Health & Health Services Research
Northwell Health
Phone: 516 465-3161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place