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

• ClinicalTrials.gov Identifier: NCT04206670
• Recruitment Status: Recruiting
• First Posted: December 20, 2019
• Last Update Posted: April 30, 2020
• Sponsor: University of California, Berkeley
• Collaborators: People Power Company; National Institute on Aging (NIA); University of California, San Francisco
• Information provided by (Responsible Party): Robert Levenson, University of California, Berkeley

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Dementia; Mild Cognitive Impairment; Alzheimer Disease	Device: In-Home Technology System and Questionnaires; Device: Waiting Control In-Home Technology System and Questionnaires	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Participants are randomly assigned to treatment arms by People Power. All participants complete the same questionnaires at the same intervals. University of California, Berkeley investigators are blind as to participants' treatment arm assignment.
• Primary Purpose: Supportive Care
• Official Title: Developing and Evaluating In-Home Supportive Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
• Actual Study Start Date: March 10, 2020
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: February 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: In-Home Technology System; Participants (N=300) will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).	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; Participants (N=100) will be assigned a date for receiving and installing the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) six months after they enter the study. During that six-month period, questionnaires (e.g., health and well-being) will be administered 3 times (at the start of the study and every 3 months thereafter). At the end of the six-month period, participants will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over an additional six-month period with questionnaires (e.g., health and well-being) administered 2 times (every 3 months following installation).	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline to 3 Months in Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: From enrollment to 3 months ]
   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.
2. Change from 3 Months to 6 Months in Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: From 3 months to 6 months ]
   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. Change from 6 Months to 9 Months in Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: From 6 months to 9 months ]
   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.
4. Change from 9 Months to 12 Months in Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: From 9 months to 12 months ]
   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.
5. Change from Baseline to 3 Months in Zarit Burden Interview-Short Form [ Time Frame: From enrollment to 3 months ]
   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. Change from 3 Months to 6 Months in Zarit Burden Interview-Short Form [ Time Frame: From 3 months to 6 months ]
   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.
7. Change from 6 Months to 9 Months in Zarit Burden Interview-Short Form [ Time Frame: From 6 months to 9 months ]
   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.
8. Change from 9 Months to 12 Months in Zarit Burden Interview-Short Form [ Time Frame: From 9 months to 12 months ]
   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. Change from Baseline to 3 Months in Beck Anxiety Inventory (BAI) [ Time Frame: From enrollment to 3 months ]
   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.
10. Change from 3 Months to 6 Months in Beck Anxiety Inventory (BAI) [ Time Frame: From 3 months to 6 months ]
    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.
11. Change from 6 Months to 9 Months in Beck Anxiety Inventory (BAI) [ Time Frame: From 6 months to 9 months ]
    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.
12. Change from 9 Months to 12 Months in Beck Anxiety Inventory (BAI) [ Time Frame: From 9 months to 12 months ]
    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.
13. Change from Baseline to 3 Months in Satisfaction with Life Scale [ Time Frame: From enrollment to 3 months ]
    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.
14. Change from 3 Months to 6 Months in Satisfaction with Life Scale [ Time Frame: From 3 months to 6 months ]
    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.
15. Change from 6 Months to 9 Months in Satisfaction with Life Scale [ Time Frame: From 6 months to 9 months ]
    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.
16. Change from 9 Months to 12 Months in Satisfaction with Life Scale [ Time Frame: From 9 months to 12 months ]
    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.
17. Change from Baseline to 3 Months in Revised Functional Limitations Battery [ Time Frame: From enrollment to 3 months ]
    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.
18. Change from 3 Months to 6 Months in Revised Functional Limitations Battery [ Time Frame: From 3 months to 6 months ]
    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.
19. Change from 6 Months to 9 Months in Revised Functional Limitations Battery [ Time Frame: From 6 months to 9 months ]
    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.
20. Change from 9 Months to 12 Months in Revised Functional Limitations Battery [ Time Frame: From 9 months to 12 months ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Tim Nelson; 855-712-9833; tim@peoplepowerco.com

Contact: Clarissa Munoz, B.S.; 510-643-8952; clarissamunoz80@berkeley.edu

Locations

United States, California

University of California, Berkeley; Recruiting

Berkeley, California, United States, 94720

Contact: Tim Nelson 855-712-9833 tim@peoplepowerco.com

Contact: Clarissa Munoz, B.S. 510-643-8952 clarissamunoz80@berkeley.edu

Sponsors and Collaborators

University of California, Berkeley

People Power Company

National Institute on Aging (NIA)

University of California, San Francisco

Investigators

• Study Director: Robert W Levenson, Ph.D.; University of California, Berkeley

More Information

Additional Information:

Presence Caregiver Research Website 

Publications:

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.

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.

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.

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.

• Responsible Party: Robert Levenson, Professor, University of California, Berkeley
• ClinicalTrials.gov Identifier: NCT04206670
• Other Study ID Numbers: R44AG059458-03 ( U.S. NIH Grant/Contract ); R44AG059458 ( U.S. NIH Grant/Contract )
• First Posted: December 20, 2019
• Last Update Posted: April 30, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Because health and other protected data are involved, we need to consult with our institutional review board and other collaborators concerning which data can be shared.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Levenson, University of California, Berkeley:

Caregivers; Dementia; Mild Cognitive Impairment; In-Home Technology; Alzheimer Disease

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Cognitive Dysfunction; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders