Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2025-12-17 @ 9:38 AM
Study NCT ID:
NCT06326424
Status:
None
Last Update Posted:
2025-04-03 00:00:00
First Post:
2024-03-05 00:00:00
Brief Title:
Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department Using Wrist Accelerometer Biosensors and Machine Learning
Status:
None
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DELIRIUM
Brief Summary:
Aim 1: (Patient and Caregiver Acceptability) Collect biosensor data on 60 older adults with dementia in the ED. The study population is any older adult with dementia in the ED who is anticipated to be in the ED or hospital for \>4 hours. The investigators will place a wrist biosensor on the dominant hand (unless prohibited by IV placement, in which case the nondominant hand will be used). The investigators will ask questions about acceptability to caregiver (if available) and patient within 4-24 hour mark after biosensor placement. The acceptability questions are derived from the Theoretical Framework of Acceptability Questionnaire.
Study end data will be collected in person prior to discharge, but if unable to be completed before discharge from the hospital, the investigators will call them back at home to complete the final survey about acceptability.
Aim 2: Correlation of biosensor data with delirium phenotype. RA will perform a CAM ICU 7 upon enrollment, and at 24 and 48 hours (or upon discharge, whichever comes first). The investigators will also collect nurse scores for RASS (agitation scores documented as part of usual clinical care), times of scoring and any other delirium or cognitive assessments done as part of usual care (e.g., CAM -ICU, delirium triage screen, mini-cog).
Biosensor data will be coordinated with RASS and presence of delirium using machine learning analysis.
Other data for covariates: medication history/medication administration records, age, gender, length of stay in the ED and in the hospital if applicable. Stage of dementia or most recent cognitive assessment. Baseline skin tone using the expanded Fitzpatrick scale (skin tone scale).
Participant exclusion criteria: patients who are intubated, getting electrical cardioversion or sedation in the ED. Patients who cannot consent due to cognitive impairment and do not have a LAR or caregiver available will also be excluded.
Study end data will be collected in person prior to discharge, but if unable to be completed before discharge from the hospital, the investigators will call them back at home to complete the final survey about acceptability.
Aim 2: Correlation of biosensor data with delirium phenotype. RA will perform a CAM ICU 7 upon enrollment, and at 24 and 48 hours (or upon discharge, whichever comes first). The investigators will also collect nurse scores for RASS (agitation scores documented as part of usual clinical care), times of scoring and any other delirium or cognitive assessments done as part of usual care (e.g., CAM -ICU, delirium triage screen, mini-cog).
Biosensor data will be coordinated with RASS and presence of delirium using machine learning analysis.
Other data for covariates: medication history/medication administration records, age, gender, length of stay in the ED and in the hospital if applicable. Stage of dementia or most recent cognitive assessment. Baseline skin tone using the expanded Fitzpatrick scale (skin tone scale).
Participant exclusion criteria: patients who are intubated, getting electrical cardioversion or sedation in the ED. Patients who cannot consent due to cognitive impairment and do not have a LAR or caregiver available will also be excluded.
Detailed Description:
Aim 1 Patient and Caregiver Acceptability Collect biosensor data on 60 older adults with dementia in the ED The study population is any older adult with dementia in the ED who is anticipated to be in the ED or hospital for 4 hours The investigators will place a wrist biosensor on the dominant hand unless prohibited by IV placement in which case the nondominant hand will be used The investigators will ask questions about acceptability to caregiver if available and patient within 4-24 hour mark after biosensor placement The acceptability questions are derived from the Theoretical Framework of Acceptability Questionnaire
Study end data will be collected in person prior to discharge but if unable to be completed before discharge from the hospital the investigators will call them back at home to complete the final survey about acceptability
Aim 2 Correlation of biosensor data with delirium phenotype RA will perform a CAM ICU 7 upon enrollment and at 24 and 48 hours or upon discharge whichever comes first The investigators will also collect nurse scores for RASS agitation scores documented as part of usual clinical care times of scoring and any other delirium or cognitive assessments done as part of usual care eg CAM -ICU delirium triage screen mini-cog
Biosensor data will be coordinated with RASS and presence of delirium using machine learning analysis
Other data for covariates medication historymedication administration records age gender length of stay in the ED and in the hospital if applicable Stage of dementia or most recent cognitive assessment Baseline skin tone using the expanded Fitzpatrick scale skin tone scale
Participant exclusion criteria patients who are intubated getting electrical cardioversion or sedation in the ED Patients who cannot consent due to cognitive impairment and do not have a LAR or caregiver available will also be excluded
Study end data will be collected in person prior to discharge but if unable to be completed before discharge from the hospital the investigators will call them back at home to complete the final survey about acceptability
Aim 2 Correlation of biosensor data with delirium phenotype RA will perform a CAM ICU 7 upon enrollment and at 24 and 48 hours or upon discharge whichever comes first The investigators will also collect nurse scores for RASS agitation scores documented as part of usual clinical care times of scoring and any other delirium or cognitive assessments done as part of usual care eg CAM -ICU delirium triage screen mini-cog
Biosensor data will be coordinated with RASS and presence of delirium using machine learning analysis
Other data for covariates medication historymedication administration records age gender length of stay in the ED and in the hospital if applicable Stage of dementia or most recent cognitive assessment Baseline skin tone using the expanded Fitzpatrick scale skin tone scale
Participant exclusion criteria patients who are intubated getting electrical cardioversion or sedation in the ED Patients who cannot consent due to cognitive impairment and do not have a LAR or caregiver available will also be excluded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None