In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Wearables

Alzheimer Disease Clinical Trial

Official title:

Commercializing In-Home Supportive Technology for Dementia Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05159557
• Other study ID #: 1247267250000-4
• Secondary ID: 2SB1AG059458-04A
• Status: Completed
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: March 25, 2024

Study information

• Verified date: May 2024
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 25, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Device:
• In-Home Technology System
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).
• Limited In-Home Technology
Intelligent bots monitor the in-home water leak sensor and provide caregivers with text messages and alerts via cell phone when worrisome conditions occur.

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Berkeley	National Institute on Aging (NIA), People Power Company, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to 3 Months in 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.	From enrollment to 3 months
Primary	Change from 3 Months to 6 Months in 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.	From 3 months to 6 months
Primary	Change from Baseline to 3 Months in 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.	From enrollment to 3 months
Primary	Change from 3 Months to 6 Months in 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 to 6 months
Primary	Change from Baseline to 3 Months in 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.	From enrollment to 3 months
Primary	Change from 3 Months to 6 Months in 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.	From 3 months to 6 months
Primary	Change from Baseline to 3 Months in 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.	From enrollment to 3 months
Primary	Change from 3 Months to 6 Months in 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.	From 3 months to 6 months
Primary	Change from Baseline to 3 Months in Revised Functional Limitations Battery	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.	From enrollment to 3 months
Primary	Change from 3 Months to 6 Months in Revised Functional Limitations Battery	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.	From 3 months to 6 months