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

University of California (UC), Berkeley

Status: Completed

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia

Treatments: Device: Waiting Control In-Home Technology System and Questionnaires; Device: In-Home Technology System and Questionnaires

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04206670

R44AG059458-03

R44AG059458 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study aims to develop and evaluate new 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.

Full description

This study aims to develop, refine, and evaluate a new 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 full operation condition will have fewer negative effects of caregiving (lower burden, better mental and physical health, higher well-being) than those in the control 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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Caregivers are fluent/literate in English
• Caregivers currently reside with spouse/family member who has received a diagnosis of Alzheimer's disease, other dementias, or mild cognitive impairment
• Caregivers primarily use a smartphone (e.g., iPhone, Android)
• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

In-Home Technology System

Experimental group

Description:

Participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six 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 and Questionnaires

Waiting Control

Other group

Description:

Participants will be assigned a date for receiving and installing the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) six months after they enter the study. During that six-month period, questionnaires (e.g., health and well-being) will be administered 3 times (at the start of the study and every 3 months thereafter). At the end of the six-month period, participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over an additional six-month period with questionnaires (e.g., health and well-being) administered 2 times (every 3 months following installation).

Treatment:

Device: Waiting Control In-Home Technology System and Questionnaires