In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Rural Homes

Browse trials for

• Alzheimer Disease 3,678
• Dementia 2,172
• Cognitive Dysfunction 3,843

Keywords

• Caregivers
• Dementia
• Mild Cognitive Impairment
• In-Home Technology
• Alzheimer's disease
• Technology
• Rural

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 15 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Lead sponsor

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.

Study arms

• Experimental
  In-Home Technology System

  The full system \[(a) 1 advanced gateway with a dual-SIM cellular connection to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights; (g) 2 Vayyar fall detection and sleep quality sensors\] will be self-installed by 60 rural caregivers 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).

  Device: In-Home Technology System

• Sham comparator
  Limited In-Home Technology System

  The full system \[(a) 1 advanced gateway with a dual-SIM cellular connection to communicate/control the equipment; (b) 5 indoor motion sensors; (c) 3 door/cabinet entry sensors; (d) 1 water leak sensor; (e) 1 "call for help" button; (f) 2 motion-activated LED night lights; (g) 2 Vayyar fall detection and sleep quality sensors\] will be self-installed by 60 rural caregivers 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.

  Device: Limited In-Home Technology

Interventions

• DeviceIn-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).

• DeviceLimited 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.

Primary outcomes

1. 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

2. 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. 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

4. 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

5. 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. 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

7. 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

8. 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

Baseline characteristics

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 29216633 ↗
• Lwi 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 28655841 ↗
• Otero 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 28395276 ↗
• Brown 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 29289452 ↗

Study documents

• Study protocol · Jul 12, 2023
• Statistical analysis plan · Jul 12, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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