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

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: NCT04206670
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : April 30, 2020
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 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Participants are randomly assigned to treatment arms by People Power. All participants complete the same questionnaires at the same intervals. University of California, Berkeley investigators are blind as to participants' treatment arm assignment.
Primary Purpose: Supportive Care
Official Title: Developing and Evaluating In-Home Supportive Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: In-Home Technology System
Participants (N=300) 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
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.

Waiting Control
Participants (N=100) 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
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.




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 6 Months to 9 Months in Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: From 6 months to 9 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.

  4. Change from 9 Months to 12 Months in Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: From 9 months to 12 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.

  5. 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.

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

  7. Change from 6 Months to 9 Months in Zarit Burden Interview-Short Form [ Time Frame: From 6 months to 9 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.

  8. Change from 9 Months to 12 Months in Zarit Burden Interview-Short Form [ Time Frame: From 9 months to 12 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.

  9. 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.

  10. 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.

  11. Change from 6 Months to 9 Months in Beck Anxiety Inventory (BAI) [ Time Frame: From 6 months to 9 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.

  12. Change from 9 Months to 12 Months in Beck Anxiety Inventory (BAI) [ Time Frame: From 9 months to 12 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.

  13. 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.

  14. 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.

  15. Change from 6 Months to 9 Months in Satisfaction with Life Scale [ Time Frame: From 6 months to 9 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.

  16. Change from 9 Months to 12 Months in Satisfaction with Life Scale [ Time Frame: From 9 months to 12 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.

  17. 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.

  18. 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.

  19. Change from 6 Months to 9 Months in Revised Functional Limitations Battery [ Time Frame: From 6 months to 9 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.

  20. Change from 9 Months to 12 Months in Revised Functional Limitations Battery [ Time Frame: From 9 months to 12 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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

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): NCT04206670


Contacts
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Contact: Tim Nelson 855-712-9833 tim@peoplepowerco.com
Contact: Clarissa Munoz, B.S. 510-643-8952 clarissamunoz80@berkeley.edu

Locations
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United States, California
University of California, Berkeley Recruiting
Berkeley, California, United States, 94720
Contact: Tim Nelson    855-712-9833    tim@peoplepowerco.com   
Contact: Clarissa Munoz, B.S.    510-643-8952    clarissamunoz80@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 W Levenson, Ph.D. University of California, Berkeley
Additional Information:
Publications:
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Responsible Party: Robert Levenson, Professor, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT04206670    
Other Study ID Numbers: R44AG059458-03 ( U.S. NIH Grant/Contract )
R44AG059458 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
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 Disease
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