An interventional study of In-Home Technology System and Questionnaires and Waiting Control In-Home Technology System and Questionnaires in Dementia, Mild Cognitive Impairment and Alzheimer Disease, sponsored by University of California, Berkeley. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by University of California, Berkeley · Not applicable, Interventional, and Supportive care
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.
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:
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 216 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of California, Berkeley is the lead sponsor of 106 studies on the registry; 18 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants 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).
Device: In-Home Technology System and Questionnaires
Participants will be assigned a date for receiving and installing the full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) six months after they enter the study. During that six-month period, questionnaires (e.g., health and well-being) will be administered 3 times (at the start of the study and every 3 months thereafter). At the end of the six-month period, participants 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 an additional six-month period with questionnaires (e.g., health and well-being) administered 2 times (every 3 months following installation).
Device: Waiting Control 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.
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.
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
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
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
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
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
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
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
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
| Milestone | In-Home Technology System | Waiting Control |
|---|---|---|
| Started | 148 | 68 |
| Completed | 124 | 65 |
| Not completed | 24 | 3 |
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.
| units on a scale | In-Home Technology System | Waiting Control |
|---|---|---|
| 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 16.05 ± 10.30 | 18.39 ± 10.27 |
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.
| units on a scale | In-Home Technology System | Waiting Control |
|---|---|---|
| 6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) | 15.98 ± 11.61 | 17.17 ± 9.55 |
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.
| units on a scale | In-Home Technology System | Waiting Control |
|---|---|---|
| 3 Months Assessment for Zarit Burden Interview-Short Form | 20.40 ± 9.19 | 21.31 ± 8.63 |
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.
| units on a scale | In-Home Technology System | Waiting Control |
|---|---|---|
| 6 Months Assessment for Zarit Burden Interview-Short Form | 20.93 ± 9.17 | 21.87 ± 8.86 |
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.
| units on a scale | In-Home Technology System | Waiting Control |
|---|---|---|
| 3 Months Assessment for Beck Anxiety Inventory (BAI) | 8.06 ± 7.71 | 9.29 ± 7.55 |
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.
| units on a scale | In-Home Technology System | Waiting Control |
|---|---|---|
| 6 Months Assessment for Beck Anxiety Inventory (BAI) | 7.81 ± 8.44 | 8.71 ± 6.53 |
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.
| units on a scale | In-Home Technology System | Waiting Control |
|---|---|---|
| 3 Months Assessment for Satisfaction With Life Scale | 21.26 ± 6.96 | 18.68 ± 7.11 |
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.
| units on a scale | In-Home Technology System | Waiting Control |
|---|---|---|
| 6 Months Assessment for Satisfaction With Life Scale | 21.28 ± 7.51 | 18.66 ± 7.06 |
Collected over Baseline to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| In-Home Technology System | 0/148 (0%) | 0/148 (0%) | 0/148 (0%) |
| Waiting Control | 0/68 (0%) | 0/68 (0%) | 0/68 (0%) |
| Age, Continuous(years) | In-Home Technology System | Waiting Control | Total |
|---|---|---|---|
| Mean | 63.7 ± 11.8 | 64.6 ± 9.8 | 63.9 ± 11.2 |
| Sex: Female, Male(Participants) | In-Home Technology System | Waiting Control | Total |
|---|---|---|---|
| Female | 90 | 51 | 141 |
| Male | 58 | 17 | 75 |
| Race/Ethnicity, Customized(Participants) | In-Home Technology System | Waiting Control | Total |
|---|---|---|---|
| Black or African American | 8 | 3 | 11 |
| East Asian, South Asian, Southeast Asian, or Indian American | 9 | 4 | 13 |
| Latino or Hispanic American | 8 | 4 | 12 |
| Native Hawaiian or Pacific Islander | 1 | 1 | 2 |
| Non-Hispanic White or European American | 108 | 51 | 159 |
| Other | 14 | 5 | 19 |
| Beck Anxiety Inventory(units on a scale) | In-Home Technology System | Waiting Control | Total |
|---|---|---|---|
| Mean | 7.36 ± 8.23 | 9.46 ± 7.12 | 8.02 ± 7.94 |
| Zarit Burden Inventory(units on a scale) | In-Home Technology System | Waiting Control | Total |
|---|---|---|---|
| Mean | 20.04 ± 8.71 | 21.35 ± 8.13 | 20.45 ± 8.53 |
| Satisfaction with Life(units on a scale) | In-Home Technology System | Waiting Control | Total |
|---|---|---|---|
| Mean | 20.99 ± 7.24 | 18.81 ± 6.85 | 20.30 ± 7.18 |
| Center for Epidemiologic Studies Depression Scale(units on a scale) | In-Home Technology System | Waiting Control | Total |
|---|---|---|---|
| Mean | 15.14 ± 10.04 | 17.90 ± 10.44 | 16.01 ± 10.22 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Because health and other protected data are involved, we need to consult with our institutional review board and other collaborators concerning which data can be shared.
Supporting information: Study protocol, Icf
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