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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039694
Receipt No. R000045274
Scientific Title Development of a new predictive model for falls among inpatients using the Japan MHLW bedriddenness rank in daily living
Date of disclosure of the study information 2020/03/04
Last modified on 2020/10/21

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Basic information
Public title Development of a new predictive model for falls among inpatients using the Japan MHLW bedriddenness rank in daily living
Acronym Development of predictive model for inpatients' fall
Scientific Title Development of a new predictive model for falls among inpatients using the Japan MHLW bedriddenness rank in daily living
Scientific Title:Acronym Development of predictive model for inpatients' fall
Region
Japan

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

Objectives
Narrative objectives1 Few predictive formulas which have been developed previously are challenging to use because of their complexity. In this study, we develop and validate a new predictive model for falls in adult inpatients using the bedriddenness rank, which is easier to use than the formula previously reported.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Inpatients' 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 All of adult inpatients
Key exclusion criteria Patient who refused an agreement
Target sample size 9000

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 81-952-34-3238
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 81-952-34-3238
Homepage URL
Email tagomas@cc.saga-u.ac.jp

Sponsor
Institute Saga University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Yuai-kai Foundation and Oda Hospital
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 03 Month 04 Day

Related information
URL releasing protocol https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236130
Publication of results Published

Result
URL related to results and publications https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236130
Number of participants that the trial has enrolled 7858
Results
7858 adult patents were available. Using model 1 consist of 13 factors, multivariate logistic regression analysis showed that the significant related factors were male, emergency admission, Department of Neurosurgery, use of hypnotic, previous falls, independent to eat, and bedriddenness rank. The AUC of model 1 was 0.808 in the test set, 0.789 in the validation set. For the model consisting of above 7 factors and age, the AUC was 0.806 in the test set, 0.787 in the validation set.
Results date posted
2020 Year 03 Month 04 Day
Results Delayed
Results Delay Reason Reject from journals
Date of the first journal publication of results
2020 Year 07 Month 16 Day
Baseline Characteristics
In the test set, 243 falls occurred (4.6%), the median age (interquartile range) was 77 years (62-85), 34% were men, the median length of hospital stay (interquartile range) was 9 (5-16) days, and the incidence rate of falls was 3.5 per 1,000 patient-days. In the validation set, 122 falls occurred (4.7%).
Participant flow
During the study period 8,343 inpatients were admitted, 8,031 of whom were aged 20 years or older. Among them, 7,858 were eligible , being randomly extracted to two groups, the test set (5,257) and the validation set (2,601).
Adverse events
None.
Outcome measures
The data in this study were extracted from the hospital's health records as follows. The variables on admission were age, sex (male and female), department of admission (Internal Medicine, Neurosurgery, or others), emergency admission (presence or absence), ambulance transfer (presence or absence), ADLs (ability to eat, go to the toilet, bathe, take prescribed medicines, and move independently), MHLW classifications for abilities of daily living, use of hypnotic medications (both benzodiazepine and non-benzodiazepine types; presence or absence), dependence on a wheelchair (presence or absence), admission with a referral letter from a primary physician (presence or absence), permanent residual damage from previous strokes, visual impairment, parkinsonism (presence or absence), and a history of falls (presence or absence). 

Primary outcome, falls during hospitalization, were identified from the fall-specific report forms in the incident reports, which were mandatorily recorded and submitted by attending medical personnel when falls occurred during a hospital stay.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 05 Month 29 Day
Date of IRB
2015 Year 09 Month 10 Day
Anticipated trial start date
2015 Year 05 Month 29 Day
Last follow-up date
2015 Year 05 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 02 Month 13 Day

Other
Other related information Data including age, sex, activity of daily living, bedriddenness rank, cognitive function score in daily living, referral letter, hyptonic, previous fall, and emergency admission and fall during hospitalization were derived from hospital records.

Management information
Registered date
2020 Year 03 Month 04 Day
Last modified on
2020 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045274

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/03/05 20150403ファイル結合転倒1追加4例.xlsx


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