Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University
- Study ID
- NCT06326424
- Status
- Recruiting
Conditions
- Delirium
- Dementia
- Hospital Acquired Condition
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Empatica EmbracePlus — DEVICEwear a biosensor watch to passively collect biosensor data over 48 hours. The EmbracePlus will collect heart rate variability, accelerometry, and electrodermal activity.
Study Details
Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital. Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients. The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools.
Key Dates
- Start date
- Apr 10, 2024
- Status verified
- Mar 2025
- Primary completion
- Mar 1, 2026
- Completion
- Mar 1, 2026
Study Design
- Enrollment
- 60 participants (estimated)
Arms
- Arm: Observational DELIRIUM cohortWe will follow up to 60 adults 65+ years old with dementia or suspected dementia who are likely to be in the emergency department, observation unit, or hospital for 48 hours. We will follow them for up to 48 hours while they wear an FDA approved biosensor watch and perform delirium checks.
Primary Outcome Measure
Proportion of participants who develop delirium [ Time Frame: over the 48 hours of study participation ]
Central Contacts
- Lauren Southerland, MD MPH614-366-8375
- Michael Hill, RN
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | - |
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