Alzheimer's Disease, Dementia, Frontotemporal Dementia
Conditions
Keywords
Caregivers, Dementia, In-Home Assistive Technology
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: 1. 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. 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.
Interventions
DEVICEIn-home technology
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.
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.
Sponsors
University of California, San Francisco
People Power Company
National Institute on Aging (NIA)
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview-Short Form | 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) | 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) | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Note that outcomes are only assessed regarding caregiver health and well-being. Patients did not provide any information; therefore, all information reported for demographics and measures is only regarding caregivers.
Participants by arm
| Arm | Count |
|---|---|
| In-Home Technology System 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).
In-home technology: 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. | 37 |
| Limited In-Home Technology System 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).
Limited in-home technology: 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. | 32 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Limited In-Home Technology System | Total | In-Home Technology System |
|---|---|---|---|
| Age, Continuous | 65.91 years STANDARD_DEVIATION 10.75 | 65.01 years STANDARD_DEVIATION 11.63 | 63.38 years STANDARD_DEVIATION 12.7 |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized East Asian, South Asian, Southeast Asian, or Indian American | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Latino or Hispanic American | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White or European American | 26 Participants | 50 Participants | 24 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Female | 27 Participants | 52 Participants | 25 Participants |
| Sex: Female, Male Male | 5 Participants | 17 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 32 |
| other Total, other adverse events | 0 / 37 | 0 / 32 |
| serious Total, serious adverse events | 0 / 37 | 0 / 32 |
Outcome results
Primary
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.
Time frame: 9 months after baseline
Population: 78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | Beck Anxiety Inventory (BAI) | 7.74 score on a scale | Standard Deviation 6.82 |
| Limited In-Home Technology System | Beck Anxiety Inventory (BAI) | 11.20 score on a scale | Standard Deviation 8.08 |
Primary
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.
Time frame: 9 months after baseline
Population: 78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | Center for Epidemiological Studies Depression Scale (CES-D) | 19.21 score on a scale | Standard Deviation 12.03 |
| Limited In-Home Technology System | Center for Epidemiological Studies Depression Scale (CES-D) | 19.30 score on a scale | Standard Deviation 12.37 |
Primary
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.
Time frame: 9 months after baseline
Population: 78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | Satisfaction With Life Scale | 17.35 score on a scale | Standard Error 7.36 |
| Limited In-Home Technology System | Satisfaction With Life Scale | 19.00 score on a scale | Standard Error 6.14 |
Primary
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.
Time frame: 9 months after baseline
Population: 78 individuals enrolled into the study, 9 individuals dropped out before completing the baseline measure, and another 9 dropped out before completing the 9-month assessment for a total 60 individuals for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | Zarit Burden Interview-Short Form | 24.58 score on a scale | Standard Deviation 8.09 |
| Limited In-Home Technology System | Zarit Burden Interview-Short Form | 25.59 score on a scale | Standard Deviation 8.44 |