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

Not Applicable

Completed

• Conditions: Alzheimer Disease; Dementia; Mild Cognitive Impairment
• Interventions: Device: In-Home Technology System and Questionnaires; Device: Waiting Control In-Home Technology System and Questionnaires

• Registration Number: NCT04206670
• Lead Sponsor: University of California, Berkeley

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.

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-20
• Study Start: 2020-03-10
• Primary Completion: 2021-12-08
• Study Completion: 2021-12-08
• Results First Submitted: 2022-03-09
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-14
• Last Update Submitted: 2022-04-14
• Results First Posted: 2022-05-10
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-Home Technology System	In-Home Technology System and Questionnaires	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).
Waiting Control	Waiting Control 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).

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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 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.

Trial Locations

Locations (1)

University of California, Berkeley; 🇺🇸 Berkeley, California, United States