Alzheimer Disease, Dementia, Mild Cognitive Impairment
Conditions
Keywords
Caregivers, Dementia, Mild Cognitive Impairment, Alzheimer's disease, Technology, Spanish
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: 1. 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. 2. 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). 3. 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.
Interventions
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).
Intelligent bots monitor the in-home water leak sensor and provide caregivers with text messages and alerts via cell phone when worrisome conditions occur.
Sponsors
People Power Company
National Institute on Aging (NIA)
University of California, San Francisco
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Months Assessment for Satisfaction With Life Scale | 6 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. |
| 6 Months Assessment for Beck Anxiety Inventory (BAI) | 6 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. |
| 3 Months Assessment for Satisfaction With Life Scale | 3 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. |
| 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 3 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. |
| 6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 6 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. |
| 3 Months Assessment for Zarit Burden Interview-Short Form | 3 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. |
| 6 Months Assessment for Zarit Burden Interview-Short Form | 6 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. |
| 3 Months Assessment for Beck Anxiety Inventory (BAI) | 3 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 6 Months Assessment for Revised Functional Limitations Battery | 6 months after baseline | Questionnaire assessing functional limitations in daily activities; higher scores = greater limitation. |
| 3 Months Assessment for Revised Functional Limitations Battery | 3 months after baseline | Questionnaire assessing functional limitations in daily activities; higher scores = greater limitation. |
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 \[(a) 1 gateway that connects with home internet to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 call for help button; (f) 2 motion-activated LED night lights; (g) 2 Vayyar fall detection and sleep quality sensors\] 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).
In-Home Technology System: 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). | 4 |
| Limited In-Home Technology System 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.
Limited In-Home Technology: Intelligent bots monitor the in-home water leak sensor and provide caregivers with text messages and alerts via cell phone when worrisome conditions occur. | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | Limited In-Home Technology System | Total | In-Home Technology System |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 12.73 | 49 years STANDARD_DEVIATION 17.3 | 50.5 years STANDARD_DEVIATION 20.63 |
| Beck Anxiety Inventory | 7 units on a scale STANDARD_DEVIATION 1.41 | 14 units on a scale STANDARD_DEVIATION 8.32 | 17.5 units on a scale STANDARD_DEVIATION 8.1 |
| Center for Epidemiologic Studies Depression Scale | 7 units on a scale STANDARD_DEVIATION 2.83 | 23.5 units on a scale STANDARD_DEVIATION 13.78 | 31.75 units on a scale STANDARD_DEVIATION 6.45 |
| Race/Ethnicity, Customized Unknown | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Hispanic/Latino | 1 Participants | 4 Participants | 3 Participants |
| Satisfaction with Life | 19.5 units on a scale STANDARD_DEVIATION 6.36 | 15.7 units on a scale STANDARD_DEVIATION 6.21 | 13 units on a scale STANDARD_DEVIATION 5.66 |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
| Zarit Burden Inventory | 16.5 units on a scale STANDARD_DEVIATION 2.12 | 24 units on a scale STANDARD_DEVIATION 9.54 | 27.75 units on a scale STANDARD_DEVIATION 9.54 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
Primary
3 Months Assessment for 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: 3 months after baseline
Population: Target enrollment was not met. Participants' group assignment was randomized and 4 participants were in the In-Home Technology System group and 2 participants were in the Limited In-Home Technology System group. This outcome measure (BAI score 3 months after baseline) is only available for 3 participants because 1 participant from the In-Home Technology System group and the only 2 participants from the Limited group dropped out within 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 3 Months Assessment for Beck Anxiety Inventory (BAI) | 13.67 units on a scale | Standard Deviation 11.5 |
Primary
3 Months Assessment for 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: 3 months after baseline
Population: Target enrollment was not met. Participants' group assignment was randomized and 4 participants were in the In-Home Technology System group and 2 participants were in the Limited In-Home Technology System group. This outcome measure (CES-D score 3 months after baseline) is only available for 3 participants because 1 participant from the In-Home Technology System group and the only 2 participants from the Limited group dropped out within 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 32.33 units on a scale | Standard Deviation 11.37 |
Primary
3 Months Assessment for 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: 3 months after baseline
Population: Target enrollment was not met. Participants' group assignment was randomized and 4 participants were in the In-Home Technology System group and 2 participants were in the Limited In-Home Technology System group. This outcome measure (SWLS score 3 months after baseline) is only available for 3 participants because 1 participant from the In-Home Technology System group and the only 2 participants from the Limited group dropped out within 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 3 Months Assessment for Satisfaction With Life Scale | 14.33 units on a scale | Standard Deviation 8.14 |
Primary
3 Months Assessment for 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: 3 months after baseline
Population: Target enrollment was not met. Participants' group assignment was randomized and 4 participants were in the In-Home Technology System group and 2 participants were in the Limited In-Home Technology System group. This outcome measure (Zarit Burden score 3 months after baseline) is only available for 3 participants because 1 participant from the In-Home Technology System group and the only 2 participants from the Limited group dropped out within 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 3 Months Assessment for Zarit Burden Interview-Short Form | 25.67 units on a scale | Standard Deviation 2.98 |
Primary
6 Months Assessment for 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: 6 months after baseline
Population: Target enrollment was not met. Participants' group assignment was randomized and 4 participants were in the In-Home Technology System group and 2 participants were in the Limited In-Home Technology System group. This outcome measure (BAI score 6 months after baseline) is only available for 2 participants because 2 participants from the In-Home Technology System group and the only 2 participants from the Limited group dropped out within 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 6 Months Assessment for Beck Anxiety Inventory (BAI) | 14 units on a scale | Standard Deviation 5.66 |
Primary
6 Months Assessment for 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: 6 months after baseline
Population: Target enrollment was not met. Participants' group assignment was randomized and 4 participants were in the In-Home Technology System group and 2 participants were in the Limited In-Home Technology System group. This outcome measure (CES-D score 6 months after baseline) is only available for 2 participants because 2 participants from the In-Home Technology System group and the only 2 participants from the Limited group dropped out within 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 29.5 units on a scale | Standard Deviation 21.92 |
Primary
6 Months Assessment for 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: 6 months after baseline
Population: Target enrollment was not met. Participants' group assignment was randomized and 4 participants were in the In-Home Technology System group and 2 participants were in the Limited In-Home Technology System group. This outcome measure (SWLS score 6 months after baseline) is only available for 2 participants because 2 participant2 from the In-Home Technology System group and the only 2 participants from the Limited group dropped out within 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 6 Months Assessment for Satisfaction With Life Scale | 14.5 units on a scale | Standard Deviation 13.44 |
Primary
6 Months Assessment for 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: 6 months after baseline
Population: Target enrollment was not met. Participants' group assignment was randomized and 4 participants were in the In-Home Technology System group and 2 participants were in the Limited In-Home Technology System group. This outcome measure (Zarit Burden score 6 months after baseline) is only available for 2 participants because 2 participants from the In-Home Technology System group and the only 2 participants from the Limited group dropped out within 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 6 Months Assessment for Zarit Burden Interview-Short Form | 26.5 units on a scale | Standard Deviation 9.19 |
Other Pre-specified
3 Months Assessment for Revised Functional Limitations Battery
Questionnaire assessing functional limitations in daily activities; higher scores = greater limitation.
Time frame: 3 months after baseline
Population: Pre-specified measure, not administered; no data available.
Other Pre-specified
6 Months Assessment for Revised Functional Limitations Battery
Questionnaire assessing functional limitations in daily activities; higher scores = greater limitation.
Time frame: 6 months after baseline
Population: Pre-specified measure, not administered; no data available.