Automating Delirium Severity in the ICU

This observational study aims to develop a new way to measure how severe delirium is in patients over 50 years old who are in the Intensive Care Unit (ICU). Delirium is a serious change in mental abilities that results in confused thinking and reduced awareness of your surroundings. Researchers will use video cameras to record patients 24 hours a day and compare this information with standard delirium assessments. The goal is to see if this new "passive digital marker" can accurately measure delirium severity and if it is acceptable and easy to use for nurses, patients, and their families. The study plans to include 400 participants and is currently unclear about its recruitment status. You might be able to join if you are over 50, expected to stay in the ICU for more than 24 hours, and not admitted for alcohol or drug-related issues.

Study design
This is an observational study with a planned enrollment of 400 participants. It aims to develop and test a new method for measuring delirium severity.
What's involved
Study participation involves 24-hour video camera recording while you are in the ICU. Study staff will visit you four times daily to ask questions and perform assessments of your mental and emotional health, mood, memory, and alertness.
Compensation
Not stated in the trial record.
Follow-up
The study will measure delirium severity between 12 and 48 months, and the acceptability and usability of the digital marker between 48 and 60 months.

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NCT06172491

Automating Delirium Severity in the ICU

Recruiting
Not specifiedAges 50+Observational
Mayo Clinic
~400 participants
Updated 2026-04-08 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Delirium Severity
Measured over 12-48 months
+2 more outcomes measured
Intensive Care Unit Delirium
Encephalopathy
Delirium
1 sites across 1 states
Minnesota1

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Eligibility criteria

Inclusion

Estimated length of stay \>24 hours in ICU; and
Are not admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.

Exclusion

Admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.
Admitted for acute neuronal injury
Unable to communicate with research team due to sensory deficits (aphasic, blind, deaf) or language (does not speak English)
  • Delirium Severity12-48 months

    The level of delirium severity will be measured by two types of prospective data collection. The first method is completed by study team members. A trained member of the study team will administer validated assessment tools 4xdaily from enrollment until ICU discharge or death. The Confusion Assessment Method for the Intensive Care Unit Severy Scale (CAM-ICU-7) is the gold standard for delirium severity measurement in the ICU. It is a 7-point scale, with 7 being severe delirium and 0 being no delirium. The second method is a passive digital marker (in development).

  • Acceptability of passive digital marker for delirium severity48 months - 60 months

    Participants and their identified care partners will be randomized 1:1 to either the Passive Digital Marker for Delirium Severity or usual care. The acceptability of the PDM by clinicians, patients, and care partners will be evaluated. The 4-question tool named Treatment Acceptability and Preference Questionnaire (TAPQ) is scored on a 5-point Likert scale. A higher score indicates higher acceptability.

  • Usability of passive digital marker for delirium severity48 months - 60 months

    Participants and their identified care partners will be randomized 1:1 to either the Passive Digital Marker for Delirium Severity or usual care. The usability of the PDM by clinicians, patients, and care partners will be evaluated. The 10-question System Usability Scale is scored on a Likert scale from 1-5. A higher score (0-100 range) indicates higher usability.