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NCT05159557 | COMPLETED | Dementia


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

University of California, Berkeley

Information provided by (Responsible Party):

Robert Levenson

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).

Condition or disease

Dementia

Mild Cognitive Impairment

Alzheimer Disease

Intervention/treatment

In-Home Technology System

Limited In-Home Technology

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 63 participants
Masking : SINGLE
Masking Description : 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.
Primary Purpose : SUPPORTIVE_CARE
Official Title : Commercializing In-Home Supportive Technology for Dementia Caregivers
Actual Study Start Date : 2022-08-22
Estimated Primary Completion Date : 2024-03-25
Estimated Study Completion Date : 2024-03-25

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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

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

Location Details

NCT05159557


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Locations


Not yet recruiting

United States, California

University of California, Berkeley

Berkeley, California, United States, 94720

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