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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040103
Receipt No. R000045659
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
Date of disclosure of the study information 2020/04/08
Last modified on 2020/11/12

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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


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