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

ConditionsDeliriumDementiaHospital Acquired Condition
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorOhio State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

older adults with dementia in the Emergency Department

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Observational DELIRIUM cohort1 intervention

Trial outcomes

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.

Time frame
over the 48 hours of study participation

Secondary outcomes

1

Intervention Acceptability

Patient and caregiver acceptability of wearing the biosensor in the hospital will be assessed with a quick 6 question survey based off the Theoretical Framework of Acceptability. Survey questions use likert scales. For example, a score of 1 corresponds to being completely unacceptable and 5 corresponds to being completely acceptable.

Time frame
Assessment completed at 48 hours or earlier if discharged prior to 48 hours
2

Biosensor data usability

Sometimes wrist biosensors are not able to detect signal well or can be dislodged or removed, which leads to periods of time without usable data. The biosensor data collected from each participant will be assessed for data quality and usability by the statistical analysis team.

Time frame
48 hours
3

Correlation of biosensor array data with clinical delirium

We will investigate the correlation of the biosensor array data (e.g., heart rate variability, electrodermal activity, and accelerometry) with the development of clinical delirium in the participants. This statistical analysis will be completed asynchronously after all the participants have finished all data collection for the study.

Time frame
up to 48 hours of biosensor and clinical data per participant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Source ClinicalTrials.gov
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