UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047064 |
|---|---|
| Receipt number | R000053687 |
| 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 |
| Date of disclosure of the study information | 2022/03/10 |
| Last modified on | 2022/03/03 16:34:28 |
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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
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
yuji-koga@umin.ac.jp
Sponsor or person
Institute
KAWASAKI MEDICAL SCHOOL HOSPITAL Department of Nursing
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053687
