Trial Outcomes & Findings for In-Home Technology for Dementia Caregivers (NCT NCT03828383)
NCT ID: NCT03828383
Last Updated: 2022-05-10
Results Overview
Questionnaire to measure caregiver burden (Zarit, Reever, \& Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
9 months after baseline
Results posted on
2022-05-10
Participant Flow
Note that outcomes are only assessed regarding caregiver health and well-being. Patients did not provide any information; therefore, all information reported for demographics and measures is only regarding caregivers.
Participant milestones
| Measure |
In-Home Technology System
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
|
Limited In-Home Technology System
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
37
|
|
Overall Study
COMPLETED
|
34
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
In-Home Technology System
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
|
Limited In-Home Technology System
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
Baseline Characteristics
In-Home Technology for Dementia Caregivers
Baseline characteristics by cohort
| Measure |
In-Home Technology System
n=37 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
|
Limited In-Home Technology System
n=32 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.38 years
STANDARD_DEVIATION 12.70 • n=5 Participants
|
65.91 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
65.01 years
STANDARD_DEVIATION 11.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian, South Asian, Southeast Asian, or Indian American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino or Hispanic American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White or European American
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 months after baselinePopulation: 78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.
Questionnaire to measure caregiver burden (Zarit, Reever, \& Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.
Outcome measures
| Measure |
In-Home Technology System
n=33 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
|
Limited In-Home Technology System
n=27 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
|
|---|---|---|
|
Zarit Burden Interview-Short Form
|
24.58 score on a scale
Standard Deviation 8.09
|
25.59 score on a scale
Standard Deviation 8.44
|
PRIMARY outcome
Timeframe: 9 months after baselinePopulation: 78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.
Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.
Outcome measures
| Measure |
In-Home Technology System
n=34 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
|
Limited In-Home Technology System
n=30 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
|
|---|---|---|
|
Center for Epidemiological Studies Depression Scale (CES-D)
|
19.21 score on a scale
Standard Deviation 12.03
|
19.30 score on a scale
Standard Deviation 12.37
|
PRIMARY outcome
Timeframe: 9 months after baselinePopulation: 78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.
Questionnaire to measure anxiety (Beck, Epstein, Brown, \& Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.
Outcome measures
| Measure |
In-Home Technology System
n=34 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
|
Limited In-Home Technology System
n=30 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
|
|---|---|---|
|
Beck Anxiety Inventory (BAI)
|
7.74 score on a scale
Standard Deviation 6.82
|
11.20 score on a scale
Standard Deviation 8.08
|
PRIMARY outcome
Timeframe: 9 months after baselinePopulation: 78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.
Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, \& Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.
Outcome measures
| Measure |
In-Home Technology System
n=34 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of sensors, provision of warnings, messaging, and social networking features will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
In-home technology: Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
|
Limited In-Home Technology System
n=30 Participants
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Limited in-home technology: Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
|
|---|---|---|
|
Satisfaction With Life Scale
|
17.35 score on a scale
Standard Error 7.36
|
19.00 score on a scale
Standard Error 6.14
|
Adverse Events
In-Home Technology System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Limited In-Home Technology System
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place