Back to resultsIn-Home Technology for Dementia Caregivers
Primary Purpose
Dementia, Alzheimer's Disease, Frontotemporal Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-home technology
Limited in-home technology
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Caregivers, Dementia, In-Home Assistive Technology
Eligibility Criteria
Inclusion Criteria:
- Caregivers are fluent/literate in English
- Caregivers currently reside with spouse/family member with dementia
- Caregivers primarily use an iPhone
- 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
If you live in the San Francisco Bay Area, Las Vegas (Clark County), Orange County, Los Angeles County, or Oregon, you may complete the following screening questionnaire to determine your eligibility for participation: https://bit.ly/UCBDC Upon completion of the screening questionnaire, the UC Berkeley research team will follow up soon after by email or phone to confirm your eligibility status.
Sites / Locations
- University of California, Berkeley
- Los Angeles County
- Orange County
- Clark County
- Oregon
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 (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). 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 nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03828383
First Posted
January 31, 2019
Last Updated
April 14, 2022
Sponsor
University of California, Berkeley
Collaborators
University of California, San Francisco, People Power Company, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03828383
Brief Title
In-Home Technology for Dementia Caregivers
Official Title
Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
November 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley
Collaborators
University of California, San Francisco, People Power Company, National Institute on Aging (NIA)
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 and evaluate in-home assistive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease and frontotemporal dementia.
Detailed Description
This study aims to develop, refine, and evaluate a hardware/software system designed to integrate in-home sensors and devices, social connection, and Internet-of-Things (i.e., devices that can be controlled and communicated with via the internet) technologies to create a more supportive and safe home environment for caregivers and people with dementia. The system monitors troublesome behaviors in people with dementia (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia 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:
Caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, higher mental and physical health, higher well-being) than those in the limited home safety condition.
Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms.
Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer's Disease, Frontotemporal Dementia
Keywords
Caregivers, Dementia, In-Home Assistive Technology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Identical system is installed in all homes regardless of treatment arm. The member of research team who does the installation will now know which treatment arm has been assigned. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff (who has no contact with the participants) following the installation.
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-Home Technology System
Arm Type
Experimental
Arm Description
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). 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 nine month period with questionnaires (e.g., health and well-being) administered 4 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 (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Intervention Type
Device
Intervention Name(s)
In-home technology
Intervention Description
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 a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
Intervention Type
Device
Intervention Name(s)
Limited in-home technology
Intervention Description
Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
Primary Outcome Measure Information:
Title
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
9 months after baseline
Title
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
9 months after baseline
Title
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
9 months after baseline
Title
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
9 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Caregivers are fluent/literate in English
Caregivers currently reside with spouse/family member with dementia
Caregivers primarily use an iPhone
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
If you live in the San Francisco Bay Area, Las Vegas (Clark County), Orange County, Los Angeles County, or Oregon, you may complete the following screening questionnaire to determine your eligibility for participation: https://bit.ly/UCBDC Upon completion of the screening questionnaire, the UC Berkeley research team will follow up soon after by email or phone to confirm your eligibility status.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W 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
Facility Name
Los Angeles County
City
Los Angeles
State/Province
California
ZIP/Postal Code
90011
Country
United States
Facility Name
Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92856
Country
United States
Facility Name
Clark County
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89108
Country
United States
Facility Name
Oregon
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Because patient 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 Dementia Caregivers
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