UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059496 |
|---|---|
| Receipt number | R000062117 |
| Scientific Title | Severity of cognitive impairment before hip fracture predicts postoperative delirium |
| Date of disclosure of the study information | 2025/10/23 |
| Last modified on | 2025/10/23 14:37:00 |
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Basic information
Public title
Severity of cognitive impairment before hip fracture predicts postoperative delirium
Acronym
Severity of cognitive impairment before hip fracture predicts postoperative delirium
Scientific Title
Severity of cognitive impairment before hip fracture predicts postoperative delirium
Scientific Title:Acronym
Severity of cognitive impairment before hip fracture predicts postoperative delirium
Region
| Japan |
Condition
Condition
Hip fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing the severity of pre-fracture cognitive impairment in older hip fracture patients to determine if it is a predictor of the development of postoperative delirium.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of delirium in the first 3 days postoperatively as measured by CAM
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hip fracture who underwent inpatient surgery
Key exclusion criteria
Lack of data
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamimura |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, JAPAN
TEL
0263372395
tkamimu@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamimura |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3908621
Address
3-1-1 Asahi Matsumoto, JAPAN
TEL
0263372395
Homepage URL
tkamimu@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Keita Tomii
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University, Life Science and Medical Research Ethics Committee
Address
3-1-1 Asahi Matsumoto JAPAN
Tel
0263372395
tkamimu@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23k10399
Org. issuing International ID_1
Japan Society for the Promotion of Science
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 23 | 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
429
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Design] Multicenter retrospective cohort study
[Eligibility Criteria] Patients aged 80 years or older who underwent surgery for acute hip fracture
[Exclusion Criteria] 1) Patients unable to complete the DASC-21, specifically those living alone with moderate or severe CI (MMSE score <21) and lacking family members or caregivers to observe ADLs; 2) In-hospital death, additional hip fracture related to falls, or other serious illness; 3) Refusal to participate in the prospective cohort study; 4) Missing data
[Assessment] The Confusion Assessment Method (CAM) will be used for delirium assessment. Cognitive function will be assessed using DASC-21 and MMSE results.
[Statistical Analysis] The association between delirium occurrence and cognitive function will be examined using logistic regression analysis.
Management information
Registered date
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062117
