Delirium Identification in Older Patients with Dementia in the Emergency Department

This study is looking at how well a special wrist device, the Empatica EmbracePlus, can help identify delirium in older patients with dementia who are in the Emergency Department (ED). Delirium is a serious medical condition where a person becomes confused and disoriented, and it's especially dangerous for those with Alzheimer's and other dementias. The study will enroll 60 participants aged 65 and older who have dementia and are expected to be in the ED or hospital for more than 4 hours. You would wear the Empatica EmbracePlus watch for up to 48 hours to collect information like heart rate and movement. Researchers will then see if this data correlates with whether you develop delirium. The goal is to find better ways to recognize delirium early.

Study design
This is an observational study with 60 participants. It is not testing a new treatment, but rather observing how a device works.
What's involved
You would wear a biosensor watch for up to 48 hours. Researchers will ask you (and a caregiver, if available) questions about the watch within 4-24 hours of placement, and again before discharge or over the phone.
Compensation
Not stated in the trial record.
Follow-up
Researchers will collect data for up to 48 hours, or until discharge if sooner. A final survey about acceptability will be completed before discharge or by phone afterwards.

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NCT06326424

Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department

Recruiting
Not specifiedAges 65+Observational
Ohio State University
~60 participants
Updated 2025-04-03 on ClinicalTrials.gov
What's tested:Empatica EmbracePlus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who develop delirium
Measured over over the 48 hours of study participation
Delirium
Dementia
Hospital Acquired Condition
1 sites across 1 states
Ohio1
  • Edward Boyer, MD · STUDY_DIRECTOR · Ohio State University

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Eligibility criteria

Inclusion

adults patients 65+ years old with a known diagnosis of dementia or medical team highly suspects or confirms dementia this visit.
Emergency Department visit and/or hospitalization anticipated to last \>4 more hours from the time of enrollment.

Exclusion

Intubation/mechanical ventilation
Patients undergoing a procedure requiring sedation
Patients who cannot consent due to cognitive impairment and do not have a legally authorized representative or caregiver present.
  • Proportion of participants who develop deliriumover the 48 hours of study participation

    The proportion of participants who develop delirium will be determined by one or more positive CAM-ICU 7 (Confusion Assessment Method- Intensive Care Unit 7) assessments during the study participation timeframe. The CAM-ICU 7 is a categorical test with 0 being no delirium and higher numbers signifying different levels of delirium.