UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047453 |
|---|---|
| Receipt number | R000054074 |
| Scientific Title | Validation of the new predictive score for inpatient's fall using public ADL scale in Japan (Bedriddenness rank and cognitive function score): single center retrospective study |
| Date of disclosure of the study information | 2022/04/10 |
| Last modified on | 2022/04/08 11:03:18 |
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Basic information
Public title
Validation of the new predictive score for inpatient's fall using public ADL scale in Japan (Bedriddenness rank and cognitive function score)
Acronym
A Validation of the predictive score for falls among inpatients
Scientific Title
Validation of the new predictive score for inpatient's fall using public ADL scale in Japan (Bedriddenness rank and cognitive function score): single center retrospective study
Scientific Title:Acronym
A Validation of the predictive score for falls among inpatients: single center retrospective study
Region
| Japan |
Condition
Condition
Fall in the hospital
Classification by specialty
| Medicine in general | Geriatrics | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the new predictive score for inpatient's fall which we developed in the previous study, in a retrospective study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity, Specificity, AUC (Area Under the Curve), shrinkage coefficient
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
inpatients aged 20 years or older admitted to Yuai-Kai Foundation and Oda Hospital
Key exclusion criteria
Patients without the data of Bedriddeness rank were excluded
Target sample size
7000
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
81-952-34-3238
tagomas@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga
TEL
81-952-34-3238
Homepage URL
tagomas@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Hospital General Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yuai-Kai Foundation and Oda Hospital
Address
4306 Takatsuhara, Kashima, Saga 849-1311, Japan
Tel
81-954-63-3275
renkei@yuai-hc.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
| 2022 | Year | 04 | 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
9344
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It was delayed because additional analysis was required.
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All inpatients aged 20 years or older were enrolled in a single-center prospective cohort study. The data including age, sex, emergency admission, department (internal medicine, neurosurgery, other), hypnotic medications, history of falls, eating, and bedriddenness rank, were collected.
Management information
Registered date
| 2022 | Year | 04 | Month | 10 | Day |
Last modified on
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054074
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/07/15 | dataset.xlsx |
