Intensive Care Unit DeliriumADS-ICUNCT06172491
Automating Delirium Severity in the ICU
An observational study of Intensive Care Unit Delirium and Encephalopathy, run by Mayo Clinic at 1 site in United States.
Trial summary
The goal of this observational study is to develop a passive digital marker (PDM) for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients >50 years of age. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intensive Care Unit Delirium, Encephalopathy, Delirium
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2023to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: Aging adults admitted to an intensive care unit
Who may be able to join
- Estimated length of stay >24 hours in ICU; and
- Are not admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Hannah Friesen, 507-284-2197, friesen.hannah@mayo.edu
Heidi Lindroth, Ph.D., R.N.
About this study
Official title: Harnessing the Power of Technology to Transform Delirium Severity Measurement in the ICU
The goal of this observational study is to develop a passive digital marker (PDM) for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients >50 years of age.
The main questions it aims to answer are:
Read more
- Is the trained convolutional neural network able to reliably measure delirium severity.
- Is the Passive Digital Marker able to accurately measure delirium severity
- Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians, patients, and their identified proxies (i.e., caregivers).
Participants will:
- Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit (ICU).
- Study staff will visit you 4 times each day you are in the ICU. You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data.
Read the detailed description
Bedside cameras will stay up for at least 72 hours (about 3 days), it may be longer if delirium is being experienced and if the patient and or LAR (Legally Authorized Representative) agree to the cameras' continued recording.
The study team will come and ask the patient questions 4 times daily. We will ask questions about their general, mental, and emotional health, their mood and memory. During these visits, the study team will check the alertness of the patient. Alertness will be checked by voice; if they do not respond, we will tap their shoulder gently. We will ask the patient to do activities like remembering words and saying them back, shaking hands, and drawing an object or clock. The study team will administer assessments 4 times daily. Participants will be asked questions about their general, mental, and emotional health, as well as mood and memory. While performing these sessions, the study team will observe the level of awareness. Awareness will be assessed by voice; if they do not respond, we will have to do a gentle tap on their shoulders. The patient will be asked to perform activities such as: remembering words and repeating them back, handshaking, and drawing an object or clock.
In some cases, if the patient's level of awareness alertness is lowered, we will do observation only perform observation assessments. These assessments do not interfere with clinical care. Participation in this study is voluntary.
The study team will continue to follow the patient until discharged from ICU.
The bedside nurse, patient, or family can cover the cameras with a washcloth if needed for privacy. The faces of family and clinicians and the bathing suit areas of patients are blurred before analysis to protect privacy.
- Conditions
- Intensive Care Unit Delirium, Encephalopathy, Delirium
- Keywords
- Delirium, Severity, Digital marker, Computer Vision, Artificial Intelligence
- Medical subject headings
- Brain Diseases, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Delirium Severity | Patients who did not experience a level of delirium severity (subsyndromal, mild, moderate, severe) | |
| Delirium Severity | Patients who did experience a level of delirium severity (subsyndromal, mild, moderate, severe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium Severity
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).
Measured: 12-48 months
Acceptability of passive digital marker for delirium severity
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.
Measured: 48 months - 60 months
Usability of passive digital marker for delirium severity
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.
Measured: 48 months - 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Jan 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit DeliriumStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi L. Lindroth PhD RN, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172491
- Sponsor's protocol ID
- 22-003098
- Acronym
- ADS-ICU
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raghu R, Nalaie K, Ayala I, Morales Behaine JJ, Garcia-Mendez JP, Friesen H, Leistikow K, Bhattacharyya A, Jayaraman A, Franco PM, Rabinstein A, Chlan LL, Boustani M, Herasevich V, Lindroth H. Harnessing the Power of Technology to Transform Delirium Severity Measurement in the Intensive Care Unit: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Sep 25;14:e62912. doi: 10.2196/62912.
PubMed 40998312
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing the Power of Technology to Transform Delirium Severity Measurement in the ICU
- ClinicalTrials.gov ID
- NCT06172491
- Acronym / sponsor ID
- ADS-ICU / 22-003098
- Conditions
- Intensive Care Unit Delirium, Encephalopathy, Delirium
- Keywords
- Delirium, Severity, Digital marker, Computer Vision, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to develop a passive digital marker (PDM) for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients >50 years of age.
The main questions it aims to answer are:
- Is the trained convolutional neural network able to reliably measure delirium severity.
- Is the Passive Digital Marker able to accurately measure delirium severity
- Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians, patients, and their identified proxies (i.e., caregivers).
Participants will:
- Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit (ICU).
- Study staff will visit you 4 times each day you are in the ICU. You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data.
Detailed description
Bedside cameras will stay up for at least 72 hours (about 3 days), it may be longer if delirium is being experienced and if the patient and or LAR (Legally Authorized Representative) agree to the cameras' continued recording.
The study team will come and ask the patient questions 4 times daily. We will ask questions about their general, mental, and emotional health, their mood and memory. During these visits, the study team will check the alertness of the patient. Alertness will be checked by voice; if they do not respond, we will tap their shoulder gently. We will ask the patient to do activities like remembering words and saying them back, shaking hands, and drawing an object or clock. The study team will administer assessments 4 times daily. Participants will be asked questions about their general, mental, and emotional health, as well as mood and memory. While performing these sessions, the study team will observe the level of awareness. Awareness will be assessed by voice; if they do not respond, we will have to do a gentle tap on their shoulders. The patient will be asked to perform activities such as: remembering words and repeating them back, handshaking, and drawing an object or clock.
In some cases, if the patient's level of awareness alertness is lowered, we will do observation only perform observation assessments. These assessments do not interfere with clinical care. Participation in this study is voluntary.
The study team will continue to follow the patient until discharged from ICU.
The bedside nurse, patient, or family can cover the cameras with a washcloth if needed for privacy. The faces of family and clinicians and the bathing suit areas of patients are blurred before analysis to protect privacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Delirium Severity | – | –Patients who did not experience a level of delirium severity (subsyndromal, mild, moderate, severe) |
| Delirium Severity | – | –Patients who did experience a level of delirium severity (subsyndromal, mild, moderate, severe) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Aging adults admitted to an intensive care unit
Key inclusion criteria (2 listed)
- Estimated length of stay >24 hours in ICU; and
- Are not admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delirium Severity
Time frame: 12-48 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 severity
Time frame: 48 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 severity
Time frame: 48 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 40998312Raghu R, Nalaie K, Ayala I, Morales Behaine JJ, Garcia-Mendez JP, Friesen H, Leistikow K, Bhattacharyya A, Jayaraman A, Franco PM, Rabinstein A, Chlan LL, Boustani M, Herasevich V, Lindroth H. Harnessing the Power of Technology to Transform Delirium Severity Measurement in the Intensive Care Unit: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Sep 25;14:e62912. doi: 10.2196/62912.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Delirium and Encephalopathy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Lindroth, PH.D. R.N. (507-284-3662, lindroth.heidi@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium Severity (time frame: 12-48 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.