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

NCT06326424 | Recruiting FDA Device

• 1 other identifier: 2023H0085
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium; Dementia; Hospital Acquired Condition

Keywords

emergency department; delirium; older adults; dementia

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who develop delirium

  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.

  over the 48 hours of study participation

Secondary Outcomes (3)

• Intervention Acceptability

  Assessment completed at 48 hours or earlier if discharged prior to 48 hours

• Biosensor data usability

  48 hours

• Correlation of biosensor array data with clinical delirium

  up to 48 hours of biosensor and clinical data per participant

Study Arms (1)

Observational DELIRIUM cohort

We 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.

Device: Empatica EmbracePlus

Interventions

Empatica EmbracePlus DEVICE

wear a biosensor watch to passively collect biosensor data over 48 hours. The EmbracePlus will collect heart rate variability, accelerometry, and electrodermal activity.

Observational DELIRIUM cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

older adults with dementia in the Emergency Department

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Delirium; Dementia; Iatrogenic Disease; Emergencies

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Edward Boyer, MD

  Ohio State University

  STUDY DIRECTOR

Central Study Contacts

Lauren Southerland, MD MPH

CONTACT

614-366-8375; lauren.southerland@osumc.edu

Michael Hill, RN

CONTACT

michael.hill@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 22, 2024
• Study Start: April 10, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)