Clinical trial NCT05159557: In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Wearables
Official title: Commercializing In-Home Supportive Technology for Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Alzheimer Disease
Keywords: Caregivers
Dementia
Mild Cognitive Impairment
Alzheimer's disease
Technology
Wearables
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: People Power Company
name: National Institute on Aging (NIA)
name: University of California, San Francisco
First posted: 2021-12-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 by integrating wearable devices (e.g., Apple Watches).

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. Caregivers in the active treatment condition will have better health and well-being (i.e., less caregiver depression, anxiety, loneliness, and burden) and greater user satisfaction compared to those in the control condition.
2. The magnitude of the difference in health and well-being benefits for caregivers in the active treatment condition compared to those in the control condition will increase over time (reflecting additional bot learning and adjustment to changing caregiver needs).
3. In the active treatment condition, greater utilization of features related to warnings (e.g., activating warnings, receiving warnings), social connection (e.g., adding Trusted Circle members), and information (e.g., accessing on-line resources through app) will be associated with greater decreases in depression and anxiety and greater increases in well-being.

Eligibility criteria: Inclusion Criteria:

* Caregivers are fluent/literate in English
* 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

Primary outcomes:
measure: 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 3 months after baseline
measure: 6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 6 months after baseline
measure: 3 Months Assessment for Zarit Burden Interview-Short Form
timeFrame: 3 months after baseline
measure: 6 Months Assessment for Zarit Burden Interview-Short Form
timeFrame: 6 months after baseline
measure: 3 Months Assessment for Beck Anxiety Inventory (BAI)
timeFrame: 3 months after baseline
measure: 6 Months Assessment for Beck Anxiety Inventory (BAI)
timeFrame: 6 months after baseline
measure: 3 Months Assessment for Satisfaction With Life Scale
timeFrame: 3 months after baseline
measure: 6 Months Assessment for Satisfaction With Life Scale
timeFrame: 6 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
affiliation: University of California, Berkeley
name: Robert Levenson, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.