NCT04206670

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

Completed NA Results posted Last updated 10 May 2022

What this trial tests

NA trial testing In-Home Technology System and Questionnaires in Dementia in 216 participants. Completed in 8 December 2021.

Timeline

10 March 2020

Primary endpoint
8 December 2021

8 December 2021

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	216
Start date	10 March 2020
Primary completion	8 December 2021
Estimated completion	8 December 2021
Sites	1 location across United States

Drugs / interventions tested

• In-Home Technology System and Questionnaires
• Waiting Control In-Home Technology System and Questionnaires

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	16.05	± 10.30
Waiting Control	18.39	± 10.27

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	15.98	± 11.61
Waiting Control	17.17	± 9.55

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	20.40	± 9.19
Waiting Control	21.31	± 8.63

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	20.93	± 9.17
Waiting Control	21.87	± 8.86

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	8.06	± 7.71
Waiting Control	9.29	± 7.55

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	7.81	± 8.44
Waiting Control	8.71	± 6.53

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	21.26	± 6.96
Waiting Control	18.68	± 7.11

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	21.28	± 7.51
Waiting Control	18.66	± 7.06

Sponsor's own description

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.

Publications & conference data

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