UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049701 |
|---|---|
| Receipt number | R000051498 |
| Scientific Title | Development of a new predictive model for inpatient's fall using public ADL scale in Japan (Bedriddennes rank and cognitrefanetion score);single-center retrospective cohort study of fall injury |
| Date of disclosure of the study information | 2022/12/10 |
| Last modified on | 2022/12/06 10:14:14 |
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Basic information
Public title
Development of a prediction model for fall injury in an acute care hospital in Japan
Acronym
Development of a prediction model for fall injury in an acute care hospital in Japan
Scientific Title
Development of a new predictive model for inpatient's fall using public ADL scale in Japan (Bedriddennes rank and cognitrefanetion score);single-center retrospective cohort study of fall injury
Scientific Title:Acronym
Development of a prediction model for fall injury in an acute care hospital in Japan: single-center retrospective cohort study;single-center retrospective cohort study
Region
| Japan |
Condition
Condition
Fall injury
Classification by specialty
| Medicine in general | Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing a model to predict fall injury for all hospitalized patients
Basic objectives2
Others
Basic objectives -Others
Exploing factors related to fall injuy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fall Injury during hospitalization
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
All patients 20 years of age or older admitted to the study facility during the study period
Key exclusion criteria
Patients who refused an agreement
Target sample size
17062
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital, Japan
Division name
Department of General Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
TEL
0952343238
tagomas@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital, Japan
Division name
Department of General Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
TEL
0952343238
Homepage URL
tagomas@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of General Medicine, Saga University Hospital
Institute
Department
Personal name
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
Yuai-Kai Foundation and Oda Hospital, Saga, Japan
Address
4306 Takatsuhara, Kashima 849-1311, Saga
Tel
0954633275
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 | 12 | 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
17062
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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 06 | Day |
Other
Other related information
For all inpatients, age, sex, department of admission (internal medicine, neurosurgery, others), emergency admission (presence or absence), ambulance transfer (presence or absence), referral letter (presence or absence), history of fall (presence or absence), hypnotic medication (presence or absence), visual impairment (presence or absence), Parkinson's syndrome (presence or absence), sequelae of stroke (presence or absence), basic ADLs (eating, swallowing, excretion, sitting, standing, transferring, moving, bathing, taking prescription drug) (independent, requiring assistance), bed-riddenness rank (normal, J, A, B, C), cognition score (normal, 1, 2, 3, 4, M), rehabilitation during hospitalization (presence or absence), surgery during hospitalization (presence or absence), fall during hospitalization (presence or absence), for the patients who fell degree of injury due to fall (no injury, LV1, 2, 3), date of admission and discharge
Management information
Registered date
| 2022 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051498
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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