In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Wearables

Not Applicable

Completed

Conditions: Alzheimer Disease
Dementia
Mild Cognitive Impairment

Interventions: Device: In-Home Technology System
Device: Limited In-Home Technology

Registration Number: NCT05159557

Lead Sponsor: University of California, Berkeley

Brief Summary: This study aims to develop, evaluate, and commercialize an in-home supportive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease, other dementias, or mild cognitive impairment by integrating wearable devices (e.g., Apple Watches).

Detailed Description: This study aims to develop, refine, evaluate, and commercialize a hardware/software system designed to integrate in-home sensors and devices, Internet-of-Things technologies (i.e., devices that can be controlled and communicated with via the internet), and social networking to create a more safe and supportive home environment for caregivers and people who have Alzheimer's disease, other dementias, or mild cognitive impairment. The system monitors troublesome behaviors in people with dementia or mild cognitive impairment (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia or mild cognitive impairment 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 active treatment condition will have better health and well-being (i.e., less caregiver depression, anxiety, loneliness, and burden) and greater user satisfaction compared to those in the control condition.

2. The magnitude of the difference in health and well-being benefits for caregivers in the active treatment condition compared to those in the control condition will increase over time (reflecting additional bot learning and adjustment to changing caregiver needs).

3. In the active treatment condition, greater utilization of features related to warnings (e.g., activating warnings, receiving warnings), social connection (e.g., adding Trusted Circle members), and information (e.g., accessing on-line resources through app) will be associated with greater decreases in depression and anxiety and greater increases in well-being.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

Inclusion Criteria

Caregivers are fluent/literate in English
Caregivers currently reside in the United States with spouse/family member who has received a medical diagnosis of Alzheimer's disease, other dementia, or mild cognitive impairment
Caregivers primarily use a smartphone (e.g., iPhone, Android)
Caregivers have internet and WiFi service

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-Home Technology System	In-Home Technology System	The full system \[(a) 1 gateway that connects with home internet to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights; (g) 1 Apple Watch to detect falls and activity outside the home\] will be self-installed by caregivers (N=60) in their homes. 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 6 month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).
Limited In-Home Technology System	Limited In-Home Technology	The full system \[(a) 1 gateway that connects with home internet to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights\], with the exception of the Apple Watch that those in the experimental condition receive will be self-installed by caregivers (N=60) in their homes. Only monitoring of the water leak and associated warnings will be activated remotely for those participants who have been randomly assigned to this limited (sham comparator) arm.

Primary Outcome Measures

Name	Time	Method
6 Months Assessment for Beck Anxiety Inventory (BAI)	6 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.
3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)	3 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.
6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)	6 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 Months Assessment for Zarit Burden Interview-Short Form	3 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.
6 Months Assessment for Zarit Burden Interview-Short Form	6 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.
3 Months Assessment for Beck Anxiety Inventory (BAI)	3 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.
3 Months Assessment for Satisfaction With Life Scale	3 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.
6 Months Assessment for Satisfaction With Life Scale	6 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.