Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

In-Home Technology for Dementia Caregivers

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: NCT03828383
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborators:
University of California, San Francisco
People Power Company
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Robert Levenson, University of California, Berkeley

Brief Summary:
This study aims to develop and evaluate in-home assistive technology that is designed to alleviate anxiety, burden, and loneliness in spousal and familial caregivers of individuals with Alzheimer's disease and frontotemporal dementia.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer's Disease Frontotemporal Dementia Device: In-home technology Device: Limited in-home technology Not Applicable

Detailed Description:

This study aims to develop, refine, and evaluate a hardware/software system designed to integrate in-home sensors and devices, social connection, and Internet-of-Things (i.e., devices that can be controlled and communicated with via the internet) technologies to create a more supportive and safe home environment for caregivers and people with dementia. The system monitors troublesome behaviors in people with dementia (e.g., wandering), and targets mechanisms (e.g., worry, social isolation) thought to link behavioral symptoms in people with dementia 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, higher mental and physical health, higher well-being) than those in the limited home safety 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Identical system is installed in all homes regardless of treatment arm. The member of research team who does the installation will now know which treatment arm has been assigned. Initiating the features of the system appropriate to the assigned treatment arm is done remotely by a member of the People Power staff (who has no contact with the participants) following the installation.
Primary Purpose: Supportive Care
Official Title: Developing and Evaluating In-Home Supportive Technology for Dementia Caregivers
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: In-Home Technology System
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). 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 nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Device: In-home technology
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 a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.

Sham Comparator: Limited In-Home Technology System
The full system (sensors for entry, activity, temperature, water leak; voice control; digital display; local router) will be installed in the homes of caregivers by a member of the research team (blind as to arm of the study). Monitoring of the water leak sensor and associated warnings will be activated remotely for those participants who have been randomly assigned to this arm. Participation will extend over a nine month period with questionnaires (e.g., health and well-being) administered 4 times (at the time of installation and every 3 months thereafter).
Device: Limited in-home technology
Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.




Primary Outcome Measures :
  1. Zarit Burden Interview-Short Form [ Time Frame: 4 times over 9-month period (at time of installation and then every 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.

  2. Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: 4 times over 9-month period (at time of installation and then every 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.

  3. Beck Anxiety Inventory (BAI) [ Time Frame: 4 times over 9-month period (at time of installation and then every 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.

  4. Satisfaction with Life Scale [ Time Frame: 4 times over 9-month period (at time of installation and then every 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.

  5. Revised Functional Limitations Battery [ Time Frame: 4 times over 9-month period (at time of installation and then every 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



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.


Layout table for eligibility information
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 with dementia
  • Caregivers primarily use an iPhone
  • 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

If you live in the San Francisco Bay Area, Las Vegas (Clark County), Orange County, Los Angeles County, or Oregon, you may complete the following screening questionnaire to determine your eligibility for participation: https://bit.ly/UCBDC Upon completion of the screening questionnaire, the UC Berkeley research team will follow up soon after by email or phone to confirm your eligibility status.


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): NCT03828383


Contacts
Layout table for location contacts
Contact: Robert W Levenson, Ph.D. 510-643-8952 boblev@berkeley.edu
Contact: Scott L Newton, B.A. 510-643-8952 scottnewton@berkeley.edu

Locations
Layout table for location information
United States, California
University of California, Berkeley Recruiting
Berkeley, California, United States, 94720
Contact: Scott L Newton, B.A.    510-643-8952    scottnewton@berkeley.edu   
Contact: Clarissa Munoz, B.S.    510-643-8952    clarissamunoz80@berkeley.edu   
Los Angeles County Recruiting
Los Angeles, California, United States, 90011
Contact: Clarissa Munoz, B.S.    510-643-8952    clarissamunoz80@berkeley.edu   
Orange County Recruiting
Orange, California, United States, 92856
Contact: Clarissa Munoz, B.S.       clarissamunoz80@berkeley.edu   
United States, Nevada
Clark County Recruiting
Las Vegas, Nevada, United States, 89108
Contact: Clarissa Munoz, B.A.    510-643-8952    clarissamunoz80@berkeley.edu   
United States, Oregon
Oregon Recruiting
Bend, Oregon, United States, 97701
Contact: Clarissa Munoz, B.S.    510-643-8952    clarissamunoz80@berkeley.edu   
Sponsors and Collaborators
University of California, Berkeley
University of California, San Francisco
People Power Company
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Study Director: Robert W Levenson, Ph.D. University of California, Berkeley

Publications:
Layout table for additonal information
Responsible Party: Robert Levenson, Professor, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT03828383     History of Changes
Other Study ID Numbers: R44AG059458 ( U.S. NIH Grant/Contract )
R44AG059458 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Because patient and other protected data are involved, we need to consult with our institutional review board and other collaborators concerning which data can be shared.

Layout table for additional information
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
In-Home Assistive Technology
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms