In-Home Technology for Dementia Caregivers

• Sponsor: University of California, Berkeley (Other)
• Overall Status: Completed
• CT.gov ID: NCT03828383
• Collaborator: University of California, San Francisco (Other), People Power Company (Industry), National Institute on Aging (NIA) (NIH)
• Enrollment: 78
• Locations: 5
• Arms: 2
• Actual Duration (Months): 21
• Patients Per Site: 15.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study aims to develop and evaluate in-home assistive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease and frontotemporal dementia.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Alzheimer's Disease; Frontotemporal Dementia	Device: In-home technology; Device: Limited in-home technology	N/A

Detailed Description

This study aims to develop, refine, and evaluate a hardware/software system designed to integrate in-home sensors and devices, social connection, and Internet-of-Things (i.e., devices that can be controlled and communicated with via the internet) technologies to create a more supportive and safe home environment for caregivers and people with dementia. The system monitors troublesome behaviors in people with dementia (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia with adverse caregiver outcomes (declines in health and well-being). The system is designed to minimize demands on caregivers' limited time and energy and to provide a platform for data collection that can be used by researchers and care professionals.

Hypotheses:

1. Caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, higher mental and physical health, higher well-being) than those in the limited home safety condition.

2. Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms.

3. Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Identical system is installed in all homes regardless of treatment arm. The member of research team who does the installation will now know which treatment arm has been assigned. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff (who has no contact with the participants) following the installation.
• Primary Purpose: Supportive Care
• Official Title: Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers
• Actual Study Start Date: Feb 26, 2019
• Actual Primary Completion Date: Nov 27, 2020
• Actual Study Completion Date: Nov 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Device: 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.
Sham Comparator: 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).	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Zarit Burden Interview-Short Form [9 months after baseline]

   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.

2. Center for Epidemiological Studies Depression Scale (CES-D) [9 months after baseline]

   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.

3. Beck Anxiety Inventory (BAI) [9 months after baseline]

   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.

4. Satisfaction With Life Scale [9 months after baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Caregivers are fluent/literate in English

• Caregivers currently reside with spouse/family member with dementia

• Caregivers primarily use an iPhone

• Caregiver has wireless internet in home

Exclusion Criteria:

• Caregivers providing care for individuals with known non-neurodegenerative conditions affecting behavior and cognition

• Caregivers providing care for individuals with longstanding Axis I psychiatric disorder

• Caregivers providing care for individuals with metabolic disorder or major organ dysfunction

• Caregivers providing care for individuals with alcohol abuse or dependence (within 5 years of dementia onset)

• Caregivers providing care for individuals with head trauma with loss of consciousness greater than 30 minutes

• Caregivers providing care for individuals with contraindications to MRI imaging

• Caregivers providing care for individuals with large confluent white matter lesions

• Caregivers providing care for individuals with significant systemic medical illness

• Caregivers providing care for individuals who use a medication likely to affect central nervous system functions adversely

If you live in the San Francisco Bay Area, Las Vegas (Clark County), Orange County, Los Angeles County, or Oregon, you may complete the following screening questionnaire to determine your eligibility for participation: https://bit.ly/UCBDC Upon completion of the screening questionnaire, the UC Berkeley research team will follow up soon after by email or phone to confirm your eligibility status.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Berkeley	Berkeley	California	United States	94720
2	Los Angeles County	Los Angeles	California	United States	90011
3	Orange County	Orange	California	United States	92856
4	Clark County	Las Vegas	Nevada	United States	89108
5	Oregon	Bend	Oregon	United States	97701

Sponsors and Collaborators

• University of California, Berkeley
• University of California, San Francisco
• People Power Company
• National Institute on Aging (NIA)

Investigators

• Study Director: Robert W Levenson, Ph.D., University of California, Berkeley

Study Documents (Full-Text)

• Study Protocol - Apr 12, 2022
• Statistical Analysis Plan - Apr 12, 2022

More Information

Publications

• Brown CL, Lwi SJ, Goodkind MS, Rankin KP, Merrilees J, Miller BL, Levenson RW. Empathic Accuracy Deficits in Patients with Neurodegenerative Disease: Association with Caregiver Depression. Am J Geriatr Psychiatry. 2018 Apr;26(4):484-493. doi: 10.1016/j.jagp.2017.10.012. Epub 2017 Dec 27.
• Chen KH, Wells JL, Otero MC, Lwi SJ, Haase CM, Levenson RW. Greater Experience of Negative Non-Target Emotions by Patients with Neurodegenerative Diseases Is Related to Lower Emotional Well-Being in Caregivers. Dement Geriatr Cogn Disord. 2017;44(5-6):245-255. doi: 10.1159/000481132. Epub 2017 Dec 8.
• Lwi SJ, Ford BQ, Casey JJ, Miller BL, Levenson RW. Poor caregiver mental health predicts mortality of patients with neurodegenerative disease. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7319-7324. doi: 10.1073/pnas.1701597114. Epub 2017 Jun 27.
• Otero MC, Levenson RW. Lower Visual Avoidance in Dementia Patients Is Associated with Greater Psychological Distress in Caregivers. Dement Geriatr Cogn Disord. 2017;43(5-6):247-258. doi: 10.1159/000468146. Epub 2017 Apr 11.

• Responsible Party: Robert Levenson, Professor, University of California, Berkeley
• ClinicalTrials.gov Identifier: NCT03828383
• Other Study ID Numbers: R44AG059458; R44AG059458
• First Posted: Feb 4, 2019
• Last Update Posted: May 10, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Robert Levenson, Professor, University of California, Berkeley: Caregivers; Dementia; In-Home Assistive Technology
• Additional relevant MeSH terms: Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	In-Home Technology System	Limited In-Home Technology System
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	41	37
COMPLETED	34	30
NOT COMPLETED	7	7

Baseline Characteristics

Arm/Group Title	In-Home Technology System	Limited In-Home Technology System	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	37	32	69
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.38 (12.70)	65.91 (10.75)	65.01 (11.63)
Sex: Female, Male (Count of Participants)
Female	25 67.6%	27 84.4%	52 75.4%
Male	12 32.4%	5 15.6%	17 24.6%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	5 13.5%	0 0%	5 7.2%
East Asian, South Asian, Southeast Asian, or Indian American	2 5.4%	1 3.1%	3 4.3%
Latino or Hispanic American	2 5.4%	2 6.3%	4 5.8%
Native Hawaiian or Pacific Islander	1 2.7%	0 0%	1 1.4%
Non-Hispanic White or European American	24 64.9%	26 81.3%	50 72.5%
Other	3 8.1%	3 9.4%	6 8.7%

Outcome Measures

1. Primary Outcome

Title	Zarit Burden Interview-Short Form
Description	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.
Time Frame	9 months after baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	In-Home Technology System	Limited In-Home Technology System
Arm/Group Description	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.	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.
Measure Participants	33	27
Mean (Standard Deviation) [score on a scale]	24.58 (8.09)	25.59 (8.44)

2. Primary Outcome

Title	Center for Epidemiological Studies Depression Scale (CES-D)
Description	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.
Time Frame	9 months after baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	In-Home Technology System	Limited In-Home Technology System
Arm/Group Description	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.	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.
Measure Participants	34	30
Mean (Standard Deviation) [score on a scale]	19.21 (12.03)	19.30 (12.37)

3. Primary Outcome

Title	Beck Anxiety Inventory (BAI)
Description	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.
Time Frame	9 months after baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	In-Home Technology System	Limited In-Home Technology System
Arm/Group Description	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.	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.
Measure Participants	34	30
Mean (Standard Deviation) [score on a scale]	7.74 (6.82)	11.20 (8.08)

4. Primary Outcome

Title	Satisfaction With Life Scale
Description	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.
Time Frame	9 months after baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	In-Home Technology System	Limited In-Home Technology System
Arm/Group Description	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.	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.
Measure Participants	34	30
Mean (Standard Error) [score on a scale]	17.35 (7.36)	19.00 (6.14)

Adverse Events

Time Frame	Baseline to 9 months
Adverse Event Reporting Description	Although 78 individuals originally enrolled in the study, only 69 individuals completed the baseline assessment. Therefore, the number for those at risk only reflect the 69 individuals for whom we had a baseline assessment.
Arm/Group Title	In-Home Technology System		Limited In-Home Technology System
Arm/Group Description	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.		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.
All Cause Mortality
	In-Home Technology System		Limited In-Home Technology System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/32 (0%)
Serious Adverse Events
	In-Home Technology System		Limited In-Home Technology System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	In-Home Technology System		Limited In-Home Technology System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/32 (0%)

Limitations/Caveats

The study intended to recruit 80 participants, 78 individuals did complete the consent form, however towards the end of enrollment, COVID-19 shutdowns occurred and our local IRB (UC Berkeley) did not allow in-person contact with participants, which ruled out the ability to install the treatment (technology) in participants' homes. The total number of participants was 69.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.