Trial Outcomes & Findings for Telemonitoring Versus Usual Care (NCT NCT01056640)
NCT ID: NCT01056640
Last Updated: 2013-02-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
205 participants
Primary outcome timeframe
12 months
Results posted on
2013-02-08
Participant Flow
Recruitment began on 11/21/09 and completed on 08/07/10. Interested subjects who passed a phone prescreen were seen at the study center or in their homes for consenting and additional study procedures to determine eligibility.
If study subjects consented to be in study and were found to be eligible, they were randomized to be in study. If they were randomized to receive the telemonitor, within 3-5 days the study team make arrangements to go to their home to install the telemonitor.
Participant milestones
| Measure |
Home Telemonitoring
The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line.
|
Usual Care
The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
103
|
|
Overall Study
COMPLETED
|
76
|
91
|
|
Overall Study
NOT COMPLETED
|
26
|
12
|
Reasons for withdrawal
| Measure |
Home Telemonitoring
The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line.
|
Usual Care
The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
8
|
|
Overall Study
Death
|
15
|
4
|
Baseline Characteristics
Telemonitoring Versus Usual Care
Baseline characteristics by cohort
| Measure |
Home Telemonitoring
n=102 Participants
The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line.
|
Usual Care
n=103 Participants
The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required.
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
97 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Age Continuous
|
80.3 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
80.2 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
80.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This study utilized an intent-to-treat method. Everyone randomized to study was included in the analysis
Outcome measures
| Measure |
Home Telemonitoring
n=102 Participants
The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line.
|
Usual Care
n=103 Participants
The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required.
|
|---|---|---|
|
Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease.
|
65 hospitalizations
Standard Deviation 63.7
|
59 hospitalizations
Standard Deviation 57.3
|
Adverse Events
Home Telemonitoring
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home Telemonitoring
n=102 participants at risk
The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.
Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line.
|
Usual Care
n=103 participants at risk
The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.
Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required.
|
|---|---|---|
|
Social circumstances
Death
|
14.7%
15/102 • Number of events 15
|
3.9%
4/103 • Number of events 4
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place