UMIN-CTR Clinical Trial

Basic information
Public title	eDIS-ICU: An international validation study to improve accuracy of screening for delirium in the ICU - A sub-analysis using ICDSC data from two institutions in Japan
Acronym	eDIS-ICU: An international validation study to improve accuracy of screening for delirium in the ICU - A sub-analysis using ICDSC data from two institutions in Japan
Scientific Title	eDIS-ICU: An international validation study to improve accuracy of screening for delirium in the ICU - A sub-analysis using ICDSC data from two institutions in Japan
Scientific Title:Acronym	eDIS-ICU: An international validation study to improve accuracy of screening for delirium in the ICU - A sub-analysis using ICDSC data from two institutions in Japan
Region	Japan Australia Europe

Condition
Condition	delirium
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate the diagnostic accuracy of eDIS-ICU and ICDSC against DSM-V.
Basic objectives2	Others
Basic objectives -Others	- Sensitivity of the eDIS-ICU compared to the ICDSC to the DSM-V (gold standard).
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	- Sensitivity of the eDIS-ICU compared to the ICDSC to the DSM-V (gold standard).
Key secondary outcomes	Prevalence of delirium during the observation period. concordance of delirium prevalence between eDIS-ICU, CAM-ICU and DSM-V. Reliability is defined as a Kappa coefficient greater than or equal to 0.6. Other measures of diagnostic accuracy (specificity, PPV, NPV, diagnostic odds). time taken (in seconds) to administer the eDIS-ICU and CAM-ICU. number of occasions in which the eDIS-ICU could be completed compared to the CAM-ICU.

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients expected to stay in the ICU for more than 24 hours upon admission. At least 18 years of age. Patients must be able to consistently communicate "Yes" and "No" verbally and non-verbally. Able to obtain consent for the study from the patient and a surrogate.
Key exclusion criteria	Patients with severe cognitive impairment that interferes with their ability to understand and answer questions. Patients who do not understand Japanese and are unable to comprehend the research consent process or evaluation instructions. Patients who have visual or hearing impairment and cannot hear verbal evaluation instructions or see the application screen.
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Koga
Organization	KAWASAKI MEDICAL SCHOOL HOSPITAL
Division name	Department of Nursing
Zip code	7010192
Address	277,Matsushima,Kurashiki,Okayama 701-0193, Japan
TEL	0864621111
Email	yuji-koga@umin.ac.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Koga
Organization	KAWASAKI MEDICAL SCHOOL HOSPITAL
Division name	Department of Nursing
Zip code	7010192
Address	577,Matsushima,Kurashiki,Okayama 701-0193, Japan
TEL	0864621111
Homepage URL
Email	yuji-koga@umin.ac.jp

Sponsor
Institute	KAWASAKI MEDICAL SCHOOL HOSPITAL Department of Nursing
Institute
Department

Funding Source
Organization	Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Saga University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	KAWASAKI MEDICAL SCHOOL
Address	577,Matsushima,Kurashiki,Okayama 701-0193, Japan
Tel	0864621111
Email	kmsrec@med.kawasaki-m.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	川崎医科大学附属病院（岡山県）、佐賀大学医学部附属病院（佐賀県）

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 10 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	Preinitiation
Date of protocol fixation	2022 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date	2022 Year 03 Month 10 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2022 Year 03 Month 03 Day
Last modified on	2022 Year 03 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053687