N/A
N=216
In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment
Dementia · Mild Cognitive Impairment · Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT04206670 ↗Enrolled (actual)
216
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) — 16.05; 18.39 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- In-Home Technology System and Questionnaires (Device); Waiting Control In-Home Technology System and Questionnaires (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Berkeley
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) |
16.05; 18.39 | — |
| PRIMARY 6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) |
15.98; 17.17 | — |
| PRIMARY 3 Months Assessment for Zarit Burden Interview-Short Form |
20.40; 21.31 | — |
| PRIMARY 6 Months Assessment for Zarit Burden Interview-Short Form |
20.93; 21.87 | — |
| PRIMARY 3 Months Assessment for Beck Anxiety Inventory (BAI) |
8.06; 9.29 | — |
| PRIMARY 6 Months Assessment for Beck Anxiety Inventory (BAI) |
7.81; 8.71 | — |
| PRIMARY 3 Months Assessment for Satisfaction With Life Scale |
21.26; 18.68 | — |
| PRIMARY 6 Months Assessment for Satisfaction With Life Scale |
21.28; 18.66 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04206670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.