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

Alzheimer Disease Clinical Trial

Official title:

Developing and Evaluating In-Home Supportive Technology for Caregivers of People With Dementia and Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206670
• Other study ID #: R44AG059458-03
• Secondary ID: R44AG059458
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: December 8, 2021

Study information

• Verified date: April 2022
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to develop and evaluate new 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.

Description:

This study aims to develop, refine, and evaluate a new 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 full operation condition will have fewer negative effects of caregiving (lower burden, better mental and physical health, higher well-being) than those in the control 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 8, 2021
• Est. primary completion date: December 8, 2021
• 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 with spouse/family member who has received a diagnosis of Alzheimer's disease, other dementias, or mild cognitive impairment
• Caregivers primarily use a smartphone (e.g., iPhone, Android)
• 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

Related Conditions & MeSH terms

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

Intervention

Device:
• In-Home Technology System and Questionnaires
Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). 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 caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.
• Waiting Control In-Home Technology System and Questionnaires
Participants self-install the in-home technology system in their homes six months after their enrollment in the study (i.e., consent procedures and initial questionnaire). 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 caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.

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	3 Months Assessment for 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.	3 months after baseline
Primary	6 Months Assessment for 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.	6 months after baseline
Primary	3 Months Assessment for 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 after baseline
Primary	6 Months Assessment for 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.	6 months after baseline
Primary	3 Months Assessment for 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.	3 months after baseline
Primary	6 Months Assessment for 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.	6 months after baseline
Primary	3 Months Assessment for 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.	3 months after baseline
Primary	6 Months Assessment for 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.	6 months after baseline

External Links

•   Presence Caregiver Research Website