N/A
Completed N=63
In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Wearables
Source: ClinicalTrials.gov NCT05159557 ↗Enrolled (actual)
63
Serious AEs
3.2%
Results posted
Jan 2025
Primary outcomePrimary: 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) — 18; 14.85 units on a scale
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 by integrating wearable devices (e.g., Apple Watches).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) |
18; 14.85 | — |
| PRIMARY 6 Months Assessment for Center for Epidemiological Studies Depression Scale (CES-D) |
16.34; 13.63 | — |
| PRIMARY 3 Months Assessment for Zarit Burden Interview-Short Form |
21.1; 19.76 | — |
| PRIMARY 6 Months Assessment for Zarit Burden Interview-Short Form |
22.86; 18.16 | — |
| PRIMARY 3 Months Assessment for Beck Anxiety Inventory (BAI) |
7.5; 7.4 | — |
| PRIMARY 6 Months Assessment for Beck Anxiety Inventory (BAI) |
9.38; 7.05 | — |
| PRIMARY 3 Months Assessment for Satisfaction With Life Scale |
18.1; 21 | — |
| PRIMARY 6 Months Assessment for Satisfaction With Life Scale |
18.03; 20.95 | — |
Eligibility Criteria
Inclusion Criteria
- Caregivers are fluent/literate in English
- 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
Data sourced from ClinicalTrials.gov (NCT05159557). 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. Informational only — not medical advice.