DementiaNCT03828383
In-Home Technology for Dementia Caregivers
A study testing In-home technology and Limited in-home technology in people with Dementia and Alzheimer's Disease, run by University of California, Berkeley at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer's Disease, Frontotemporal Dementia
- What is being tested?
- In-home technology and Limited in-home technology
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Feb 2019to 27 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Oregon
Bend, Oregon, 97701
University of California, Berkeley
Berkeley, California, 94720
Clark County
Las Vegas, Nevada, 89108
Los Angeles County
Los Angeles, California, 90011
Orange County
Orange, California, 92856
About this study
Official title: Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers
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.
Read the 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.
- Conditions
- Dementia, Alzheimer's Disease, Frontotemporal Dementia
- Being tested
- In-home technology, Limited in-home technology
- Keywords
- Caregivers, Dementia, In-Home Assistive Technology
- Medical subject headings
- Dementia, Alzheimer Disease, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home technologyDevice
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.
Limited in-home technologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| In-Home Technology System | Experimental | 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). Receives: Device: In-home technology |
| Limited In-Home Technology System | Sham comparator | 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). Receives: Device: Limited in-home technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months after baseline
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.
Measured: 9 months after baseline
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.
Measured: 9 months after baseline
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.
Measured: 9 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start26 Feb 2019
- Primary completion27 Nov 2020
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, People Power Company, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Robert Levenson, University of California, Berkeley
- Investigators
- Robert W Levenson, Ph.D., Study director, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828383
- Sponsor's protocol ID
- R44AG059458
- Other IDs
- R44AG059458
- Status last verified
- Apr 2022
- First submitted
- 31 Jan 2019
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 29216633Lwi 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.
PubMed 28655841Otero 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.
PubMed 28395276Brown 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.
PubMed 29289452Bullard BM, Brown CL, Scheffer JA, Toledo AB, Levenson RW. Emotion Regulation Strategies and Mental Health in Dementia Caregivers: The Moderating Role of Gender. Dement Geriatr Cogn Disord. 2024;53(3):128-134. doi: 10.1159/000538398. Epub 2024 Apr 22.
PubMed 38537622
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers
- ClinicalTrials.gov ID
- NCT03828383
- Acronym / sponsor ID
- R44AG059458
- Conditions
- Dementia, Alzheimer's Disease, Frontotemporal Dementia
- Keywords
- Caregivers, Dementia, In-Home Assistive Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of California, San Francisco, People Power Company, National Institute on Aging (NIA)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Home Technology System | Experimental | Device: In-home technologyThe 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). |
| Limited In-Home Technology System | Sham comparator | Device: Limited in-home technologyThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-home technologyIntelligent 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. | Device | In-Home Technology System |
| Limited in-home technologyIntelligent 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. | Device | Limited In-Home Technology System |
Primary outcome
Zarit Burden Interview-Short Form
Time frame: 9 months after baseline
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)
Time frame: 9 months after baseline
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)
Time frame: 9 months after baseline
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
Time frame: 9 months after baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29216633Chen 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.
- Background: PubMed 28655841Lwi 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.
- Background: PubMed 28395276Otero 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.
- Background: PubMed 29289452Brown 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.
- Derived from this study: PubMed 38537622Bullard BM, Brown CL, Scheffer JA, Toledo AB, Levenson RW. Emotion Regulation Strategies and Mental Health in Dementia Caregivers: The Moderating Role of Gender. Dement Geriatr Cogn Disord. 2024;53(3):128-134. doi: 10.1159/000538398. Epub 2024 Apr 22.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Levenson, Ph.D. study director
University of California, Berkeley
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-home technology and Limited in-home technology in people with Dementia and Alzheimer's Disease, run by University of California, Berkeley at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Burden Interview-Short Form (time frame: 9 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03828383, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.