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Clinical Trials/NCT05159596
NCT05159596
Completed
Not Applicable

Commercializing In-Home Supportive Technology for Dementia Caregivers

University of California, Berkeley1 site in 1 country6 target enrollmentSeptember 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
University of California, Berkeley
Enrollment
6
Locations
1
Primary Endpoint
3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)
Status
Completed
Last Updated
7 months ago

Overview

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 Spanish language homes.

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. Spanish-speaking 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 Spanish-speaking 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.

Registry
clinicaltrials.gov
Start Date
September 20, 2022
End Date
October 30, 2023
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert Levenson

Professor of the Graduate School, Department of Psychology

University of California, Berkeley

Eligibility Criteria

Inclusion Criteria

  • Caregivers speak Spanish in their homes
  • 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 primarily use a smartphone (e.g., iPhone, Android)
  • Caregivers have internet and WiFi service

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

Outcomes

Primary Outcomes

3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)

Time Frame: 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.

6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D)

Time Frame: 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.

3 Months Assessment for Zarit Burden Interview-Short Form

Time Frame: 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

Time Frame: 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.

3 Months Assessment for Beck Anxiety Inventory (BAI)

Time Frame: 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 Beck Anxiety Inventory (BAI)

Time Frame: 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

Time Frame: 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.

6 Months Assessment for Satisfaction With Life Scale

Time Frame: 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.

Study Sites (1)

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