UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060922 |
|---|---|
| Receipt number | R000069721 |
| Scientific Title | Reliability and Validity of the Japanese Version of the UB-CAM for Delirium Assessment in ICU Patients (UB-CAM-J-ICU) |
| Date of disclosure of the study information | 2026/03/13 |
| Last modified on | 2026/03/13 14:19:38 |
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Basic information
Public title
Reliability and Validity of the Japanese Version of the UB-CAM for Delirium Assessment in ICU Patients (UB-CAM-J-ICU)
Acronym
UB-CAM-J-ICU
Scientific Title
Reliability and Validity of the Japanese Version of the UB-CAM for Delirium Assessment in ICU Patients (UB-CAM-J-ICU)
Scientific Title:Acronym
Reliability and Validity of the Japanese UB-CAM in ICU Patients (UB-CAM-J-ICU)
Region
| Japan |
Condition
Condition
Delirium
Classification by specialty
| Psychiatry | Anesthesiology | Intensive care medicine |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the reliability and validity of the Japanese version of the UB-CAM in ICU patients. Specifically, using DSM-5 diagnosis by psychiatrists as the reference standard, we will evaluate the diagnostic accuracy of the Japanese version of the UB-CAM (sensitivity and specificity) and assess inter-rater reliability among nurses.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the reliability and validity of the Japanese version of the UB-CAM as a delirium assessment tool
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic accuracy of the Japanese version of the UB-CAM (sensitivity and specificity), using DSM-5 diagnosis by psychiatrists as the reference standard
Key secondary outcomes
Diagnostic accuracy indices of the Japanese version of the UB-CAM (positive predictive value, negative predictive value, and diagnostic odds ratio), inter-rater reliability between two nurses (kappa coefficient), delirium prevalence during the study period, agreement between the Japanese version of the UB-CAM and DSM-5 diagnosis, and time required for UB-CAM assessment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 70 years or older who are scheduled for ICU admission and are capable of providing informed consent for study participation.
Key exclusion criteria
Patients with a diagnosis of dementia at admission, organic central nervous system injury, a history of psychiatric disorder, severe hearing or visual impairment, or difficulty in communication required for delirium assessment.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Koga |
Organization
Oita University of Nursing and Health Sciences
Division name
Division of Adult Nursing
Zip code
870-1201
Address
2944-9 Megusuno, Oita-City, Oita 870-1201, Japan
TEL
097-586-4400
koga@oita-nhs.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Koga |
Organization
Oita University of Nursing and Health Sciences
Division name
Adult Nursing Division
Zip code
870-1201
Address
2944-9 Megusuno, Oita-City, Oita 870-1201, Japan
TEL
097-586-4400
Homepage URL
koga@oita-nhs.ac.jp
Sponsor or person
Institute
Oita University of Nursing and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Oita University Hospital (Oita Prefecture)
Hirosaki University Hospital (Aomori Prefecture)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics and Safety Committee, Oita University of Nursing and Health Sciences
Address
2944-9 Megusuno, Oita-City, Oita 870-1201, Japan
Tel
097-586-4300
rinri@oita-nhs.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is an observational study, and the recruitment status is set as "Enrolling by invitation" because eligible participants are limited to patients receiving care at the participating institutions. The first informed consent was obtained on February 27, 2026, and data collection for the first participant started on March 3, 2026. Therefore, this registration is being made after study initiation.
Management information
Registered date
| 2026 | Year | 03 | Month | 13 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069721
