Intelligent Intensive Care Unit
ICU_Delirium
Motion Analysis of Delirium in Intensive Care Units (ICUs) Subtitle 1: "ADAPT: Autonomous Delirium Monitoring and Adaptive Prevention"
4 other identifiers
observational
130
1 country
1
Brief Summary
Delirium, as a common complication of hospitalization, poses significant health problems in hospitalized patients. Though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. A common characterization of delirium is change in activity level, causing patients to become hyperactive or hypoactive which is manifested in facial expressions and total body movements. This pilot study is designed to test the feasibility of a delirium detection system using movement data obtained from 3-axis wearable accelerometers and commercially available camera with facial recognition video system in conjunction with electronics medical record (EMR) data to analyze the relation of whole-body movement and facial expressions with delirium.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2028
ExpectedJune 29, 2025
June 1, 2025
4.1 years
May 29, 2015
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
CAM/CAM-ICU
Confusion Assessment Method for detection of delirium
Changes from Baseline up to 7 Days
Memorial Delirium Assessment Scale (MDAS) will be used for changes from baseline up to 7 days between the groups.
MDAS denotes motor profile and defines motor subtyping. It has 10 items which assesses several areas of cognitive functioning (memory, attention, orientation and disturbances in thinking) and psychomotor activity. The items are rated on a four point scale (0-3) based on the current interaction with the patient or by assessment of behavior. A score of 13 shows the diagnosis of delirium.
Changes from Baseline up to 7 Days
Delirium Motor Subtyping Scale (DMSS-4) will be used for changes from baseline up to 7 days between the groups.
Scoring from DMSS-4 which has 5 hyperactive and 8 hypoactive symptoms requires at least two symptoms to be present from either the hyperactive or hypoactive list to meet subtype criteria. The higher the score the higher the delirium.
Changes from Baseline up to 7 Days
Freedman Sleep Scale
To determine sleep quality of patient for given day.
Changes from Baseline up to 7 Days
Secondary Outcomes (2)
Number of subjects who died
Baseline up to 7 Days
Number of subjects on mechanical ventilation
greater than 48 hours
Other Outcomes (2)
Facial amimia versus non-amimia expressions between the groups
Changes from Baseline up to 7 Days
Dynamic activity versus static position
Changes from Baseline up to 7 Days
Study Arms (3)
Delirium group
ICU patients with a positive Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod).
Control group
ICU patients with a negative Confusion Assessment Method (CAM) score; observational using accelerometers, commercially available camera, and Internet Pod (iPod).
Healthy control group
Healthy subjects that sleep in their home environment; observational using accelerometers, cortisol swabs, and Internet Pod (iPod)
Interventions
Confusion Assessment Method (CAM) score
3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor
As part of facial recognition video system
Monitors noise levels in the room
Cortisol level collected through self administered salivary swab
Eligibility Criteria
ICU Patients: Patients who been hospitalized in an intensive care unit and have risk factors to develop delirium or delirium has been suspected by their medical provider. Healthy Controls: People who are healthy and sleep in their home environment.
You may qualify if:
- Intensive care unit patient
- years of age or older
You may not qualify if:
- Anticipated intensive care unit stay less than one day
- Less than 18 years of age
- Inability to wear a motion sensor watch (ActiGraph)
- years of age or older.
- sleeps in home environment
- does not sleep in home environment
- Less than 18 years of age
- Inability to wear a motion sensor watch (ActiGraph)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UF Health
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Azra Bihorac, MD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 8, 2015
Study Start
February 1, 2016
Primary Completion
March 11, 2020
Study Completion (Estimated)
May 30, 2028
Last Updated
June 29, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share