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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2024-01-30

Brief Summary

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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 in rural homes.

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Detailed Description

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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. Rural caregivers in the active treatment condition will have better health and well-being (i.e., less caregiver depression, anxiety, loneliness, and burden) and higher user satisfaction compared to those in the control condition.
2. The magnitude of the difference in health and well-being and user satisfaction for rural caregivers in the active treatment condition compared to those in the control condition will increase over time (reflecting additional bot learning and ability to adjust to changing caregiver needs).
3. In the active treatment condition, greater utilization of features (e.g., selecting and receiving warnings, obtaining daily reports, accessing social support services) will be associated with better caregiver health and well-being and higher user satisfaction.

Conditions

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Dementia Mild Cognitive Impairment Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Participants are randomly assigned to treatment arms by People Power. Identical systems are self-installed by caregivers in all homes regardless of treatment arm. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff following the installation. All participants complete the same questionnaires at the same intervals.

Study Groups

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In-Home Technology System

The full system \[(a) 1 advanced gateway with a dual-SIM cellular connection to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights; (g) 2 Vayyar fall detection and sleep quality sensors\] will be self-installed by 60 rural 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).

Group Type EXPERIMENTAL

In-Home Technology System

Intervention Type DEVICE

Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages and alerts via cell phone when worrisome behaviors occur. Caregivers are able to: (a) select services (e.g., warnings for falls, wandering, late night activity); (b) access daily reports (summaries of daily activities that can also be shared with health care providers); and (c) obtain support (e.g. Caregiver Support Groups that connect caregivers with knowledgeable experts and other caregivers, Caregiver Events that provide virtual meetings about relevant topics, and Trusted Circle task management to distribute the caregiving work load).

Limited In-Home Technology System

The full system \[(a) 1 advanced gateway with a dual-SIM cellular connection to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights; (g) 2 Vayyar fall detection and sleep quality sensors\] will be self-installed by 60 rural caregivers in their homes. Only monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm.

Group Type SHAM_COMPARATOR

Limited In-Home Technology

Intervention Type DEVICE

Intelligent bots monitor the in-home water leak sensor and provide caregivers with text messages and alerts via cell phone when worrisome conditions occur.

Interventions

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In-Home Technology System

Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages and alerts via cell phone when worrisome behaviors occur. Caregivers are able to: (a) select services (e.g., warnings for falls, wandering, late night activity); (b) access daily reports (summaries of daily activities that can also be shared with health care providers); and (c) obtain support (e.g. Caregiver Support Groups that connect caregivers with knowledgeable experts and other caregivers, Caregiver Events that provide virtual meetings about relevant topics, and Trusted Circle task management to distribute the caregiving work load).

Intervention Type DEVICE

Limited In-Home Technology

Intelligent bots monitor the in-home water leak sensor and provide caregivers with text messages and alerts via cell phone when worrisome conditions occur.

Intervention Type DEVICE

Eligibility Criteria

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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 live in rural areas (using Rural-Urban Commuting Area Codes data)
* Caregivers primarily use a smartphone (e.g., iPhone, Android)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes