In-Home Technology for Dementia Caregivers

NCT ID: NCT03828383

Last Updated: 2022-05-10

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2020-11-27

Brief Summary

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This study aims to develop and evaluate in-home assistive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease and frontotemporal dementia.

Detailed Description

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This study aims to develop, refine, and evaluate a hardware/software system designed to integrate in-home sensors and devices, social connection, and Internet-of-Things (i.e., devices that can be controlled and communicated with via the internet) technologies to create a more supportive and safe home environment for caregivers and people with dementia. The system monitors troublesome behaviors in people with dementia (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia 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, higher mental and physical health, higher well-being) than those in the limited home safety 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.

Conditions

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Dementia Alzheimer's Disease Frontotemporal Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
Identical system is installed in all homes regardless of treatment arm. The member of research team who does the installation will now know which treatment arm has been assigned. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff (who has no contact with the participants) following the installation.

Study Groups

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In-Home Technology System

The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). 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 nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).

Group Type EXPERIMENTAL

In-home technology

Intervention Type DEVICE

Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.

Limited In-Home Technology System

The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).

Group Type SHAM_COMPARATOR

Limited in-home technology

Intervention Type DEVICE

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

Interventions

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In-home technology

Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.

Intervention Type DEVICE

Limited in-home technology

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Caregivers are fluent/literate in English
* Caregivers currently reside with spouse/family member with dementia
* Caregivers primarily use an iPhone
* 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

If you live in the San Francisco Bay Area, Las Vegas (Clark County), Orange County, Los Angeles County, or Oregon, you may complete the following screening questionnaire to determine your eligibility for participation: https://bit.ly/UCBDC Upon completion of the screening questionnaire, the UC Berkeley research team will follow up soon after by email or phone to confirm your eligibility status.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

People Power Company

INDUSTRY

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Robert Levenson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert W Levenson, Ph.D.

Role: STUDY_DIRECTOR

University of California, Berkeley

Locations

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University of California, Berkeley

Berkeley, California, United States

Site Status

Los Angeles County

Los Angeles, California, United States

Site Status

Orange County

Orange, California, United States

Site Status

Clark County

Las Vegas, Nevada, United States

Site Status

Oregon

Bend, Oregon, United States

Site Status

Countries

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United States

References

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Chen KH, Wells JL, Otero MC, Lwi SJ, Haase CM, Levenson RW. Greater Experience of Negative Non-Target Emotions by Patients with Neurodegenerative Diseases Is Related to Lower Emotional Well-Being in Caregivers. Dement Geriatr Cogn Disord. 2017;44(5-6):245-255. doi: 10.1159/000481132. Epub 2017 Dec 8.

Reference Type BACKGROUND
PMID: 29216633 (View on PubMed)

Lwi SJ, Ford BQ, Casey JJ, Miller BL, Levenson RW. Poor caregiver mental health predicts mortality of patients with neurodegenerative disease. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):7319-7324. doi: 10.1073/pnas.1701597114. Epub 2017 Jun 27.

Reference Type BACKGROUND
PMID: 28655841 (View on PubMed)

Otero MC, Levenson RW. Lower Visual Avoidance in Dementia Patients Is Associated with Greater Psychological Distress in Caregivers. Dement Geriatr Cogn Disord. 2017;43(5-6):247-258. doi: 10.1159/000468146. Epub 2017 Apr 11.

Reference Type BACKGROUND
PMID: 28395276 (View on PubMed)

Brown CL, Lwi SJ, Goodkind MS, Rankin KP, Merrilees J, Miller BL, Levenson RW. Empathic Accuracy Deficits in Patients with Neurodegenerative Disease: Association with Caregiver Depression. Am J Geriatr Psychiatry. 2018 Apr;26(4):484-493. doi: 10.1016/j.jagp.2017.10.012. Epub 2017 Dec 27.

Reference Type BACKGROUND
PMID: 29289452 (View on PubMed)

Bullard BM, Brown CL, Scheffer JA, Toledo AB, Levenson RW. Emotion Regulation Strategies and Mental Health in Dementia Caregivers: The Moderating Role of Gender. Dement Geriatr Cogn Disord. 2024;53(3):128-134. doi: 10.1159/000538398. Epub 2024 Apr 22.

Reference Type DERIVED
PMID: 38537622 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R44AG059458

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R44AG059458

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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