UMIN-CTR Clinical Trial

Basic information
Public title	Development of a new predictive model for inpatient's fall using public ADL scale in Japan (Bedriddenness rank and cognitive function score)
Acronym	New predictive model for inpatient's fall using public ADL scale
Scientific Title	Validation of a new predictive model for inpatient's fall using public ADL scale in Japan (Bedriddenness rank and cognitive function score);Two-center prospective observational study
Scientific Title:Acronym	Validation of a new predictive model for inpatient's fall using public ADL scale in Japan;Two-center prospective observational study
Region	Japan

Condition
Condition	Adult inpatient
Classification by specialty	Nursing Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Validate the utility of the predictive fall model developed for risk assessment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fall 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	Adult inpatients
Key exclusion criteria	Patient who refused an agreement
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Tago
Organization	Saga University Hospital
Division name	General Medicine
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga 849-8501, Japan
TEL	0952-34-3238
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
Division name	General Medicine
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga 849-8501, Japan
TEL	0952-34-3238
Homepage URL
Email	tagomas@cc.saga-u.ac.jp

Sponsor
Institute	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
Address	4306 Takatsuhara, Kashima, Saga 849-1311, Japan
Tel	0954-63-3275
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	2020 Year 04 Month 08 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	3757
Results	All 141(3.8%) among 3757 patients had a fall. In univariate analysis, the group with falls was older, higher rates of patients admitted in emergency, admitted to departments of Internal medicine/Neurosurgery, used sleeping pills, fell previously, are independent in food intake. They had a different rates of falls by bedrriddenness rank (p<0.05). The AUC of the prediction model for falls in the whole patients, Oda, and Fuji Yamato were 0.77, 0.80 and 0.62 , respectively.
Results date posted	2020 Year 10 Month 20 Day
Results Delayed	Delay expected
Results Delay Reason	The results are difficult to interpret and take time to perform additional analyses.
Date of the first journal publication of results
Baseline Characteristics	141 falls occurred (3.8%), the median age (interquartile range) was 77 years (64-86), 48.3% were men, the median length of hospital stay (interquartile range) was 9 (4-9) days, and the incidence rate of falls was 2.44 per 1,000 patient-days.
Participant flow	During the study period 3,757 inpatients were eligible.
Adverse events	None
Outcome measures	Fall during hospitalization
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 09 Month 25 Day
Date of IRB	2019 Year 06 Month 25 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 11 Month 01 Day
Date of closure to data entry	2020 Year 04 Month 20 Day
Date trial data considered complete	2020 Year 05 Month 01 Day
Date analysis concluded	2020 Year 06 Month 01 Day

Other
Other related information	Age, gender, emergency admission, use of hypnotics, history of falls, Bedriddenness rank, cognitive function score, presence of referrals, and falls during hospitalization are obtained from the electronic medical record.

Management information
Registered date	2020 Year 04 Month 08 Day
Last modified on	2020 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045659

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name
2020/11/12	20201112 UMIN登録2施設転倒予測モデル検証.xlsx

Contact us.