NCT05159557

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

Completed NA Results posted Last updated 17 September 2025

What this trial tests

NA trial testing In-Home Technology System in Dementia in 63 participants. Completed in 25 March 2024.

Timeline

22 August 2022

Primary endpoint
25 March 2024

25 March 2024

Quick facts

Lead sponsor	University of California, Berkeley
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	63
Start date	22 August 2022
Primary completion	25 March 2024
Estimated completion	25 March 2024
Sites	1 location across United States

Drugs / interventions tested

• In-Home Technology System
• Limited In-Home Technology

Conditions studied

• Dementia — all drugs for Dementia →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

University of California, Berkeley

Who can join

18 and older, any sex, with Dementia or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
In-Home Technology System	18	± 9.34
Limited In-Home Technology System	14.85	± 7.73

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

Group	Value	95% CI
In-Home Technology System	16.34	± 8.96
Limited In-Home Technology System	13.63	± 6.41

3 Months Assessment for Zarit Burden Interview-Short Form Primary · 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.

Group	Value	95% CI
In-Home Technology System	21.1	± 8.08
Limited In-Home Technology System	19.76	± 9.2

6 Months Assessment for Zarit Burden Interview-Short Form Primary · 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.

Group	Value	95% CI
In-Home Technology System	22.86	± 9.76
Limited In-Home Technology System	18.16	± 7.39

3 Months Assessment for Beck Anxiety Inventory (BAI) Primary · 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.

Group	Value	95% CI
In-Home Technology System	7.5	± 6.21
Limited In-Home Technology System	7.4	± 6.5

6 Months Assessment for Beck Anxiety Inventory (BAI) Primary · 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.

Group	Value	95% CI
In-Home Technology System	9.38	± 7.93
Limited In-Home Technology System	7.05	± 6.11

3 Months Assessment for Satisfaction With Life Scale Primary · 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.

Group	Value	95% CI
In-Home Technology System	18.1	± 6.84
Limited In-Home Technology System	21	± 8.23

6 Months Assessment for Satisfaction With Life Scale Primary · 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.

Group	Value	95% CI
In-Home Technology System	18.03	± 5.76
Limited In-Home Technology System	20.95	± 7.85

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

In-Home Technology System

Serious: 1/31 (3%)

Deaths: 0/31

Limited In-Home Technology System

Serious: 1/32 (3%)

Deaths: 1/32

Serious adverse events (2 terms)

Reaction	System	In-Home Technology System	Limited In-Home Technology…
General health hospitalization and eventual transfer to hospice	General disorders	—	—
Fall resulting in hospitalization	General disorders	—	—

Most-reported serious reactions: General health hospitalization and eventual transfer to hospice, Fall resulting in hospitalization.

Data from ClinicalTrials.gov NCT05159557 adverse events section.

Sponsor's own description

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 by integrating wearable devices (e.g., Apple Watches).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.