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

Study Overview
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Brief Summary
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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
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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: 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. Greater use of the social networking features of the system will be associated with fewer caregiver depressive symptoms. Greater utilization of the home safety features of the system will be associated with fewer caregiver anxiety symptoms.

Official Title
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Developing and Evaluating In-Home Supportive Technology for Caregivers of People With Dementia and Mild Cognitive Impairment

Conditions
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Dementia, Mild Cognitive Impairment, Alzheimer Disease

Intervention / Treatment
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* Device: In-Home Technology System and Questionnaires
* Device: Waiting Control In-Home Technology System and Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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>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<br>* 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.<br>|
| Other: Waiting Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Dementia, Mild Cognitive Impairment, In-Home Technology, Alzheimer Disease