UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061236 |
|---|---|
| Receipt number | R000070069 |
| Scientific Title | A multicenter repeated point prevalence study of delirium recognition in hospitalized non-cancer patients, comparing 4AT-based assessment by trained raters with clinical documentation in medical records |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/11 14:40:54 |
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Basic information
Public title
Multicenter repeated point prevalence study of the recognition gap of delirium in hospitalized non-cancer patients
Acronym
Delirium Recognition Gap Study in Non-cancer Inpatients
Scientific Title
A multicenter repeated point prevalence study of delirium recognition in hospitalized non-cancer patients, comparing 4AT-based assessment by trained raters with clinical documentation in medical records
Scientific Title:Acronym
4AT-based Delirium Recognition Study in Non-cancer Inpatients
Region
| Japan |
Condition
Condition
Delirium in hospitalized patients with non-cancer progressive life-limiting illnesses
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Nephrology |
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Delirium is a common and clinically important syndrome among hospitalized patients, and failure to recognize it may lead to inappropriate management and poorer outcomes. However, in hospitalized patients with non-cancer progressive life-limiting illnesses, the gap between delirium detected by a standardized tool and delirium recognized and documented by the clinical team has not been sufficiently studied. This multicenter study aims to estimate the proportion of delirium cases identified by trained raters using the 4AT on the same day that are also recognized and documented as delirium by physicians or nurses in the medical record. In addition, the study will explore point prevalence of delirium, associations of recognition status with outcomes and interventions, and inter-facility variation.
Basic objectives2
Others
Basic objectives -Others
Assessment of real-world delirium recognition in clinical practice
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients judged to have delirium by trained raters using the 4AT on the same day who were also recognized and documented as having delirium in the medical record by physicians or nurses
Key secondary outcomes
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
Hospitalized patients meeting all of the following criteria will be included:
Admitted to a general ward of a participating institution.
Have a non-cancer progressive life-limiting illness.
Present in the ward on the study assessment day.
Judged eligible according to the operational criteria predefined in the study protocol.
Delirium assessment can be performed, or the reason for non-availability can be recorded.
Key exclusion criteria
1) Patients managed in the ICU or HCU
2) Patients who declined participation through the opt-out process
3) Patients for whom even minimal required data collection is not feasible on the study day
4) Patients considered inappropriate for inclusion by the principal investigator or subinvestigators
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kawabata |
Organization
Osaka Rosai Hospital
Division name
Department of Palliative Care
Zip code
591-8025
Address
1179-3 Nagasone-cho Kita-ku Sakai city Osaka
TEL
072-252-3561
off.kawabata@gmail.com
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kawabata |
Organization
Osaka Rosai Hospital
Division name
Department of Palliative Care
Zip code
5918025
Address
1179-3 Nagasone-cho Kita-ku Sakai city Osaka
TEL
072-252-3561
Homepage URL
off.kawabata@gmail.com
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Rosai Hospital
Address
1179-3 Nagasone-cho Kita-ku Sakai city Osaka
Tel
072-252-3561
somuk-osakah@m.johas.go.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 | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter observational study without intervention, conducted under routine clinical practice. Consent procedures will follow approval by each institutional review board and will be handled using an opt-out approach where applicable.
Management information
Registered date
| 2026 | Year | 04 | Month | 12 | Day |
Last modified on
| 2026 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070069
