In-Home Technology for Dementia Caregivers

Not Applicable

Completed

• Conditions: Frontotemporal Dementia; Dementia; Alzheimer's Disease
• Interventions: Device: Limited in-home technology; Device: In-home technology

• Registration Number: NCT03828383
• Lead Sponsor: University of California, Berkeley

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Study Start: 2019-02-26
• Primary Completion: 2020-11-27
• Study Completion: 2020-11-27
• Results First Submitted: 2022-03-09
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-14
• Last Update Submitted: 2022-04-14
• Results First Posted: 2022-05-10
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

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 (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).
In-Home Technology System	In-home technology	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).

Primary Outcome Measures

Name	Time	Method
Zarit Burden Interview-Short Form	9 months after baseline	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.
Center for Epidemiological Studies Depression Scale (CES-D)	9 months after baseline	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.
Beck Anxiety Inventory (BAI)	9 months after baseline	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.
Satisfaction With Life Scale	9 months after baseline	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.

Trial Locations

Locations (5)

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

Clark County; 🇺🇸 Las Vegas, Nevada, United States

Oregon; 🇺🇸 Bend, Oregon, United States

Orange County; 🇺🇸 Orange, California, United States

Los Angeles County; 🇺🇸 Los Angeles, California, United States