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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Alzheimer Disease; Dementia
• Interventions: Device: Limited In-Home Technology; Device: In-Home Technology System

• Registration Number: NCT05159596
• Lead Sponsor: University of California, Berkeley

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.

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. Spanish-speaking 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 Spanish-speaking 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.

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-16
• Study Start: 2022-09-20
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limited In-Home Technology System	Limited In-Home Technology	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 Spanish-speaking caregivers (N=60) 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.
In-Home Technology System	In-Home Technology System	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 Spanish-speaking caregivers (N=60) 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).

Primary Outcome Measures

Name	Time	Method
Change from Baseline to 3 Months in Beck Anxiety Inventory (BAI)	From enrollment to 3 months	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.
Change from 3 Months to 6 Months in Beck Anxiety Inventory (BAI)	From 3 months to 6 months	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.
Change from Baseline to 3 Months in Revised Functional Limitations Battery	From enrollment to 3 months	Questionnaire to measure functional health (Brim, Ryff, \& Kessler, 2004). 13 items asking about limitations in two parts (yes/no and if they have the limitation rating its duration on a 1-3 score). Items are summed (range 0-39). Higher scores indicate worse outcomes.
Change from Baseline to 3 Months in Zarit Burden Interview-Short Form	From enrollment to 3 months	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.
Change from 3 Months to 6 Months in Satisfaction with Life Scale	From 3 months to 6 months	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.
Change from Baseline to 3 Months in Center for Epidemiological Studies Depression Scale (CES-D)	From enrollment to 3 months	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.
Change from 3 Months to 6 Months in Center for Epidemiological Studies Depression Scale (CES-D)	From 3 months to 6 months	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.
Change from 3 Months to 6 Months in Zarit Burden Interview-Short Form	3 months to 6 months	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.
Change from Baseline to 3 Months in Satisfaction with Life Scale	From enrollment to 3 months	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.
Change from 3 Months to 6 Months in Revised Functional Limitations Battery	From 3 months to 6 months	Questionnaire to measure functional health (Brim, Ryff, \& Kessler, 2004). 13 items asking about limitations in two parts (yes/no and if they have the limitation rating its duration on a 1-3 score). Items are summed (range 0-39). Higher scores indicate worse outcomes.

Trial Locations

Locations (1)

University of California, Berkeley; 🇺🇸 Berkeley, California, United States