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

NCT05159596 | Completed Results DMC

• 2 other identifiers: 1247267250000-22SB1AG059458-04A1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 in Spanish language homes.

Conditions

Dementia; Mild Cognitive Impairment; Alzheimer Disease

Keywords

Caregivers; Dementia; Mild Cognitive Impairment; Alzheimer's disease; Technology; Spanish

Outcome Measures

Primary Outcomes (8)

• 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)

  Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.

  3 months after baseline

• 6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)

  Questionnaire to measure depression (Radloff, 1977). 20 items are rated on a 0-3 scale and summed (range = 0-60). There are no subscales. Higher scores represent worse outcomes. The clinical cut-off is usually set at a score of 16.

  6 months after baseline

• 3 Months Assessment for Zarit Burden Interview-Short Form

  Questionnaire to measure caregiver burden (Zarit, Reever, \& Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.

  3 months after baseline

• 6 Months Assessment for Zarit Burden Interview-Short Form

  Questionnaire to measure caregiver burden (Zarit, Reever, \& Bach-Peterson, 1980). 12 items are rated on 0-4 scale. Range: 0-48. No subscales. Higher scores represent worse outcomes.

  6 months after baseline

• 3 Months Assessment for Beck Anxiety Inventory (BAI)

  Questionnaire to measure anxiety (Beck, Epstein, Brown, \& Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.

  3 months after baseline

• 6 Months Assessment for Beck Anxiety Inventory (BAI)

  Questionnaire to measure anxiety (Beck, Epstein, Brown, \& Steer, 1988). 20 items are rated on a 0-3 scale and summed (range= 0-60). Higher scores indicate worse outcomes. There are no subscales. A score greater than 36 is considered to be clinically significant.

  6 months after baseline

• 3 Months Assessment for Satisfaction With Life Scale

  Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, \& Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.

  3 months after baseline

• 6 Months Assessment for Satisfaction With Life Scale

  Questionnaire measuring overall life satisfaction and well-being (Diener, Emmons, Larsen, \& Griffin, 1985). 5 items scored on a 1-7 scale and summed (Range = 5-35). Lower scores indicate worse outcomes. A score of 20 is considered neutral with higher scores considered increasingly more satisfied and lower scores considered increasingly more dissatisfied.

  6 months after baseline

Other Outcomes (2)

• 3 Months Assessment for Revised Functional Limitations Battery

  3 months after baseline

• 6 Months Assessment for Revised Functional Limitations Battery

  6 months after baseline

Study Arms (2)

In-Home Technology System

EXPERIMENTAL

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

Device: In-Home Technology System

Limited In-Home Technology System

SHAM COMPARATOR

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

Device: Limited In-Home Technology

Interventions

In-Home Technology System 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).

In-Home Technology System

Limited In-Home Technology 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.

Limited In-Home Technology System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers speak Spanish in their homes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• People Power Company: collaborator
• National Institute on Aging (NIA): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

Related Publications (4)

• 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.

  PMID: 29216633 BACKGROUND

• 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.

  PMID: 28655841 BACKGROUND

• 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.

  PMID: 28395276 BACKGROUND

• 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.

  PMID: 29289452 BACKGROUND

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases

Limitations and Caveats

Enrollment was challenging in this Spanish-speaking population; recruitment efforts continued for the duration of the study. 48 caregivers expressed interest by completing a screening questionnaire but then were unreachable or declined participation before enrolling. Two caregivers enrolled and completed the first questionnaire packet but discontinued prior to being assigned to a group. The study was completed when final participant finished as planned (i.e., study was not terminated early).

Results Point of Contact

• Title: Robert W. Levenson
• Organization: University of California, Berkeley

boblev@berkeley.edu

510-643-8952

Study Officials

• Robert Levenson, Ph.D.

  University of California, Berkeley

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Graduate School, Department of Psychology

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 16, 2021
• Study Start: September 20, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)