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

University of California (UC), Berkeley

Status: Completed

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia

Treatments: Device: Limited In-Home Technology; Device: In-Home Technology System

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05159557

1247267250000-4

2SB1AG059458-04A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

In-Home Technology System

Experimental group

Description:

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 60 caregivers 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).

Treatment:

Device: In-Home Technology System

Limited In-Home Technology System

Sham Comparator group

Description:

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 60 caregivers 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.

Treatment:

Device: Limited In-Home Technology