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

Study Overview
=================
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 rural 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: Rural 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. The magnitude of the difference in health and well-being and user satisfaction for rural 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). 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.

Official Title
-----------------
Commercializing In-Home Supportive Technology for Dementia Caregivers

Conditions
-----------------
Dementia, Mild Cognitive Impairment, Alzheimer Disease

Intervention / Treatment
-----------------
* Device: In-Home Technology System
* Device: Limited In-Home Technology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caregivers are fluent/literate in English 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 live in rural areas (using Rural-Urban Commuting Area Codes data) Caregivers primarily use a smartphone (e.g., iPhone, Android) 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-Home Technology System<br>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 rural 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). | Device: In-Home Technology System<br>* 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).<br>|
| Sham Comparator: Limited In-Home Technology System<br>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 rural 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. | Device: Limited In-Home Technology<br>* Intelligent bots monitor the in-home water leak sensor and provide caregivers with text messages and alerts via cell phone when worrisome conditions occur.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to 3 Months in 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. | From enrollment to 3 months | 
| Change from 3 Months to 6 Months in 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. | From 3 months to 6 months | 
| Change from Baseline to 3 Months in 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. | From enrollment to 3 months | 
| Change from 3 Months to 6 Months in 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. | 3 months to 6 months | 
| Change from Baseline to 3 Months in 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. | From enrollment to 3 months | 
| Change from 3 Months to 6 Months in 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. | From 3 months to 6 months | 
| Change from Baseline to 3 Months in 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. | From enrollment to 3 months | 
| Change from 3 Months to 6 Months in 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. | From 3 months to 6 months | 
| Change from Baseline to 3 Months in Revised Functional Limitations Battery | Questionnaire to measure functional health (Brim, Ryff, & Kessler, 2004). 13 items asking about limitations in two parts (yes/no and if they have the limitation rating its duration on a 1-3 score). Items are summed (range 0-39). Higher scores indicate worse outcomes. | From enrollment to 3 months | 
| Change from 3 Months to 6 Months in Revised Functional Limitations Battery | Questionnaire to measure functional health (Brim, Ryff, & Kessler, 2004). 13 items asking about limitations in two parts (yes/no and if they have the limitation rating its duration on a 1-3 score). Items are summed (range 0-39). Higher scores indicate worse outcomes. | From 3 months to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caregivers, Dementia, Mild Cognitive Impairment, In-Home Technology, Alzheimer's disease, Technology, Rural