Alzheimer Disease, Dementia, Mild Cognitive Impairment
Conditions
Keywords
Caregivers, Dementia, Mild Cognitive Impairment, In-Home Technology, Alzheimer Disease
Brief summary
This study aims to develop and evaluate new 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.
Detailed description
This study aims to develop, refine, and evaluate a new 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. Caregivers in the full operation condition will have fewer negative effects of caregiving (lower burden, better mental and physical health, higher well-being) than those in the control 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 System and Questionnaires
Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). 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 caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.
DEVICEWaiting Control In-Home Technology System and Questionnaires
Participants self-install the in-home technology system in their homes six months after their enrollment in the study (i.e., consent procedures and initial questionnaire). 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 caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.
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. All participants complete the same questionnaires at the same intervals. University of California, Berkeley investigators are blind as to participants' treatment arm assignment.
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 who has received a diagnosis of Alzheimer's disease, other dementias, or mild cognitive impairment * Caregivers primarily use a smartphone (e.g., iPhone, Android) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
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 Participants (N=300) will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six 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 and Questionnaires: Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). 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 caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment. | 148 |
| Waiting Control Participants (N=300) will receive and install the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) in their homes. Remote assistance will be provided to help with the installation. Sensors, warnings, messaging, and social networking features will be activated remotely. Participation will extend over a six 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 and Questionnaires: Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). 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 caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment. | 68 |
| Total | 216 |
Baseline characteristics
| Characteristic | Total | In-Home Technology System | Waiting Control |
|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 11.2 | 63.7 years STANDARD_DEVIATION 11.8 | 64.6 years STANDARD_DEVIATION 9.8 |
| Beck Anxiety Inventory | 8.02 units on a scale STANDARD_DEVIATION 7.94 | 7.36 units on a scale STANDARD_DEVIATION 8.23 | 9.46 units on a scale STANDARD_DEVIATION 7.12 |
| Center for Epidemiologic Studies Depression Scale | 16.01 units on a scale STANDARD_DEVIATION 10.22 | 15.14 units on a scale STANDARD_DEVIATION 10.04 | 17.90 units on a scale STANDARD_DEVIATION 10.44 |
| Race/Ethnicity, Customized Black or African American | 11 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized East Asian, South Asian, Southeast Asian, or Indian American | 13 Participants | 9 Participants | 4 Participants |
| Race/Ethnicity, Customized Latino or Hispanic American | 12 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White or European American | 159 Participants | 108 Participants | 51 Participants |
| Race/Ethnicity, Customized Other | 19 Participants | 14 Participants | 5 Participants |
| Satisfaction with Life | 20.30 units on a scale STANDARD_DEVIATION 7.18 | 20.99 units on a scale STANDARD_DEVIATION 7.24 | 18.81 units on a scale STANDARD_DEVIATION 6.85 |
| Sex: Female, Male Female | 141 Participants | 90 Participants | 51 Participants |
| Sex: Female, Male Male | 75 Participants | 58 Participants | 17 Participants |
| Zarit Burden Inventory | 20.45 units on a scale STANDARD_DEVIATION 8.53 | 20.04 units on a scale STANDARD_DEVIATION 8.71 | 21.35 units on a scale STANDARD_DEVIATION 8.13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 148 | 0 / 68 |
| other Total, other adverse events | 0 / 148 | 0 / 68 |
| serious Total, serious adverse events | 0 / 148 | 0 / 68 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 3 Months Assessment for Beck Anxiety Inventory (BAI) | 8.06 units on a scale | Standard Deviation 7.71 |
| Waiting Control | 3 Months Assessment for Beck Anxiety Inventory (BAI) | 9.29 units on a scale | Standard Deviation 7.55 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 16.05 units on a scale | Standard Deviation 10.3 |
| Waiting Control | 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 18.39 units on a scale | Standard Deviation 10.27 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 3 Months Assessment for Satisfaction With Life Scale | 21.26 units on a scale | Standard Deviation 6.96 |
| Waiting Control | 3 Months Assessment for Satisfaction With Life Scale | 18.68 units on a scale | Standard Deviation 7.11 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 3 Months Assessment for Zarit Burden Interview-Short Form | 20.40 units on a scale | Standard Deviation 9.19 |
| Waiting Control | 3 Months Assessment for Zarit Burden Interview-Short Form | 21.31 units on a scale | Standard Deviation 8.63 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 6 Months Assessment for Beck Anxiety Inventory (BAI) | 7.81 units on a scale | Standard Deviation 8.44 |
| Waiting Control | 6 Months Assessment for Beck Anxiety Inventory (BAI) | 8.71 units on a scale | Standard Deviation 6.53 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 15.98 units on a scale | Standard Deviation 11.61 |
| Waiting Control | 6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 17.17 units on a scale | Standard Deviation 9.55 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 6 Months Assessment for Satisfaction With Life Scale | 21.28 units on a scale | Standard Deviation 7.51 |
| Waiting Control | 6 Months Assessment for Satisfaction With Life Scale | 18.66 units on a scale | Standard Deviation 7.06 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-Home Technology System | 6 Months Assessment for Zarit Burden Interview-Short Form | 20.93 units on a scale | Standard Deviation 9.17 |
| Waiting Control | 6 Months Assessment for Zarit Burden Interview-Short Form | 21.87 units on a scale | Standard Deviation 8.86 |