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In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Spanish Language Homes

Primary Purpose

Dementia, Mild Cognitive Impairment, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Home Technology System
Limited In-Home Technology
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Caregivers, Dementia, Mild Cognitive Impairment, Alzheimer's disease, Technology, Spanish

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Caregivers speak Spanish in their homes
  • 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

Sites / Locations

  • University of California, BerkeleyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

In-Home Technology System

Limited In-Home Technology System

Arm Description

The full system [(a) 1 gateway that connects with home internet to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights; (g) 2 Vayyar fall detection and sleep quality sensors] will be self-installed by Spanish-speaking caregivers (N=60) in their homes. 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 6 month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).

The full system [(a) 1 gateway that connects with home internet to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights; (g) 2 Vayyar fall detection and sleep quality sensors] will be self-installed by Spanish-speaking caregivers (N=60) in their homes. Only monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2021
Last Updated
August 16, 2022
Sponsor
University of California, Berkeley
Collaborators
People Power Company, National Institute on Aging (NIA), University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05159596
Brief Title
In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Spanish Language Homes
Official Title
Commercializing In-Home Supportive Technology for Dementia Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley
Collaborators
People Power Company, National Institute on Aging (NIA), University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 in Spanish language homes.
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: Spanish-speaking caregivers in the active treatment condition will have better health and well-being (i.e., less caregiver depression, anxiety, loneliness, and burden) and higher user satisfaction compared to those in the control condition. The magnitude of the difference in health and well-being and user satisfaction for Spanish-speaking caregivers in the active treatment condition compared to those in the control condition will increase over time (reflecting additional bot learning and ability to adjust to changing caregiver needs). In the active treatment condition, greater utilization of features (e.g., selecting and receiving warnings, obtaining daily reports, accessing social support services) will be associated with better caregiver health and well-being and higher user satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mild Cognitive Impairment, Alzheimer Disease
Keywords
Caregivers, Dementia, Mild Cognitive Impairment, Alzheimer's disease, Technology, Spanish

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Participants are randomly assigned to treatment arms by People Power. Identical systems are self-installed by caregivers in all homes regardless of treatment arm. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff following the installation. All participants complete the same questionnaires at the same intervals.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-Home Technology System
Arm Type
Experimental
Arm Description
The full system [(a) 1 gateway that connects with home internet to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights; (g) 2 Vayyar fall detection and sleep quality sensors] will be self-installed by Spanish-speaking caregivers (N=60) in their homes. 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 6 month period with questionnaires (e.g., health and well-being) administered 3 times (at the time of installation and every 3 months thereafter).
Arm Title
Limited In-Home Technology System
Arm Type
Sham Comparator
Arm Description
The full system [(a) 1 gateway that connects with home internet to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights; (g) 2 Vayyar fall detection and sleep quality sensors] will be self-installed by Spanish-speaking caregivers (N=60) in their homes. Only monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm.
Intervention Type
Device
Intervention Name(s)
In-Home Technology System
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Limited In-Home Technology
Intervention Description
Intelligent bots monitor the in-home water leak sensor and provide caregivers with text messages and alerts via cell phone when worrisome conditions occur.
Primary Outcome Measure Information:
Title
Change from Baseline to 3 Months in Center for Epidemiological Studies Depression Scale (CES-D)
Description
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.
Time Frame
From enrollment to 3 months
Title
Change from 3 Months to 6 Months in Center for Epidemiological Studies Depression Scale (CES-D)
Description
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.
Time Frame
From 3 months to 6 months
Title
Change from Baseline to 3 Months in Zarit Burden Interview-Short Form
Description
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.
Time Frame
From enrollment to 3 months
Title
Change from 3 Months to 6 Months in Zarit Burden Interview-Short Form
Description
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.
Time Frame
3 months to 6 months
Title
Change from Baseline to 3 Months in Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
From enrollment to 3 months
Title
Change from 3 Months to 6 Months in Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
From 3 months to 6 months
Title
Change from Baseline to 3 Months in Satisfaction with Life Scale
Description
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.
Time Frame
From enrollment to 3 months
Title
Change from 3 Months to 6 Months in Satisfaction with Life Scale
Description
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.
Time Frame
From 3 months to 6 months
Title
Change from Baseline to 3 Months in Revised Functional Limitations Battery
Description
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.
Time Frame
From enrollment to 3 months
Title
Change from 3 Months to 6 Months in Revised Functional Limitations Battery
Description
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.
Time Frame
From 3 months to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Caregivers speak Spanish in their homes 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Newton, B.A.
Phone
510-643-8952
Email
scottnewton@berkeley.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Yee, Ph.D.
Phone
510-643-8952
Email
claireyee@berkeley.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Levenson, Ph.D.
Organizational Affiliation
University of California, Berkeley
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Newton, B.A.
Phone
510-643-8952
Email
scottnewton@berkeley.edu
First Name & Middle Initial & Last Name & Degree
Claire Yee, Ph.D.
Phone
510-643-8952
Email
claireyee@berkeley.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
29216633
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.
Results Reference
background
PubMed Identifier
28655841
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.
Results Reference
background
PubMed Identifier
28395276
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.
Results Reference
background
PubMed Identifier
29289452
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.
Results Reference
background

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In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Spanish Language Homes

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