UMIN-CTR Clinical Trial

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
Email	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
Email	tagomas@cc.saga-u.ac.jp

Sponsor
Institute	Department of General Medicine, Saga University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051498