In-Home Technology for Dementia Caregivers

Study Overview
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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: 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. Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms. Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.

Official Title
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Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers

Conditions
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Dementia, Alzheimer's Disease, Frontotemporal Dementia

Intervention / Treatment
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* Device: In-home technology
* Device: Limited in-home technology


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-Home Technology System<br>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). | Device: In-home technology<br>* 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.<br>|
| Sham Comparator: Limited In-Home Technology System<br>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). | Device: Limited in-home technology<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 months after baseline | 
| 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. | 9 months after baseline | 
| 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. | 9 months after baseline | 
| 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. | 9 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Dementia, In-Home Assistive Technology