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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05159583
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : August 18, 2022
Sponsor:
Collaborators:
People Power Company
National Institute on Aging (NIA)
University of California, San Francisco
Information provided by (Responsible Party):
Robert Levenson, University of California, Berkeley

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.

Condition or disease Intervention/treatment Phase
Dementia Mild Cognitive Impairment Alzheimer Disease Device: In-Home Technology System Device: Limited In-Home Technology Not Applicable

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:

  1. 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.
  2. 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).
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Participants are randomly assigned to treatment arms by People Power. Identical systems are self-installed by caregivers in all homes regardless of treatment arm. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff following the installation. All participants complete the same questionnaires at the same intervals.
Primary Purpose: Supportive Care
Official Title: Commercializing In-Home Supportive Technology for Dementia Caregivers
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
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 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
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).

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 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
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 Outcome Measures :
  1. Change from Baseline to 3 Months in Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: From enrollment to 3 months ]
    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.

  2. Change from 3 Months to 6 Months in Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: From 3 months to 6 months ]
    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. Change from Baseline to 3 Months in Zarit Burden Interview-Short Form [ Time Frame: From enrollment to 3 months ]
    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.

  4. Change from 3 Months to 6 Months in Zarit Burden Interview-Short Form [ Time Frame: 3 months to 6 months ]
    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.

  5. Change from Baseline to 3 Months in Beck Anxiety Inventory (BAI) [ Time Frame: From enrollment to 3 months ]
    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. Change from 3 Months to 6 Months in Beck Anxiety Inventory (BAI) [ Time Frame: From 3 months to 6 months ]
    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.

  7. Change from Baseline to 3 Months in Satisfaction with Life Scale [ Time Frame: From enrollment to 3 months ]
    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.

  8. Change from 3 Months to 6 Months in Satisfaction with Life Scale [ Time Frame: From 3 months to 6 months ]
    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.

  9. Change from Baseline to 3 Months in Revised Functional Limitations Battery [ Time Frame: From enrollment to 3 months ]
    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.

  10. Change from 3 Months to 6 Months in Revised Functional Limitations Battery [ Time Frame: From 3 months to 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05159583


Contacts
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Contact: Scott Newton, B.A. 510-643-8952 scottnewton@berkeley.edu
Contact: Claire Yee, Ph.D. 510-643-8952 claireyee@berkeley.edu

Locations
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United States, California
University of California, Berkeley Recruiting
Berkeley, California, United States, 94720
Contact: Scott Newton, B.A.    510-643-8952    scottnewton@berkeley.edu   
Contact: Claire Yee, Ph.D.    510-643-8952    claireyee@berkeley.edu   
Sponsors and Collaborators
University of California, Berkeley
People Power Company
National Institute on Aging (NIA)
University of California, San Francisco
Investigators
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Study Director: Robert Levenson, Ph.D. University of California, Berkeley
Publications:
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Responsible Party: Robert Levenson, Professor of the Graduate School, Department of Psychology, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT05159583    
Other Study ID Numbers: 1247267250000-1
2SB1AG059458-04A1 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2021    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Levenson, University of California, Berkeley:
Caregivers
Dementia
Mild Cognitive Impairment
In-Home Technology
Alzheimer's disease
Technology
Rural
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders