UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045420
Receipt number R000050831
Scientific Title A Validation and practical application research of the predictive model for falls among inpatients using bedriddenness ranks in various medical institutions
Date of disclosure of the study information 2021/09/15
Last modified on 2024/03/11 09:08:59

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Basic information

Public title

A Validation and practical application research of the predictive model for falls among inpatients using Japanese public ADL scale in various medical institutions

Acronym

A Validation and practical application research of the predictive model for falls among inpatients

Scientific Title

A Validation and practical application research of the predictive model for falls among inpatients using bedriddenness ranks in various medical institutions

Scientific Title:Acronym

A Validation and practical application research of the predictive model for falls among inpatients

Region

Japan


Condition

Condition

Fall, Fall injury

Classification by specialty

Medicine in general Geriatrics Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1. To validate two predictive models which we developed for falls and fall injury among inpatients, and develop a system for practical use.
2. To evaluate the criterion-related validity of Bedriddenness Rank with other established objective scales of ADLs, and Cognitive Function Score with those of cognitive impairment.

Basic objectives2

Others

Basic objectives -Others

The discrimination of tow models are evaluated by AUC and Calibration coefficient. Criterion-related validity are evaluated by Spearman's correlation coefficient.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Inpatients' falls during hospitalization

Key secondary outcomes

Fall injury, Katz index, MMSE


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 adult inpatients

Key exclusion criteria

Patients who do not give consent to the study

Target sample size

7818


Research contact person

Name of lead principal investigator

1st name Masaki
Middle name
Last name Tago

Organization

Saga University Hospital

Division name

Department of General Medicine

Zip code

849-8501

Address

5-1-1 Nabeshima Saga, Saga, Japan

TEL

0952-34-3238

Email

tagomas@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name Naoko
Middle name E
Last name Katsuki

Organization

Saga University Hospital

Division name

Department of General Medicine

Zip code

849-8501

Address

5-1-1 Nabeshima Saga, Saga, Japan

TEL

0952-34-3238

Homepage URL


Email

d4180@cc.saga-u.ac.jp


Sponsor or person

Institute

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

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

CRINICAL RESEARCH CENTER, SAGA UNIVERSITY HOSPITAL

Address

5-1-1 Nabeshima, Saga, Saga, Japan

Tel

0952-34-3400

Email

kenkyu-shinsei@ml.cc.saga-u.ac.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

佐賀大学医学部付属病院(佐賀県)、佐賀県医療センター好生館(佐賀県)、独立行政法人国立病院機構嬉野医療センター(佐賀県)、社会医療法人祐愛会織田病院(佐賀県)、唐津市民病院きたはた(佐賀県)、医療法人長生会島田病院(佐賀県)、地方独立行政法人静岡県立病院機構静岡県立総合病院(静岡県)、国保国吉病院組合いすみ医療センター(千葉県)


Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 15 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

144770

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

We need additional time for data collection and writing the article.

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

Main results already published

Date of protocol fixation

2021 Year 09 Month 01 Day

Date of IRB

2021 Year 09 Month 29 Day

Anticipated trial start date

2021 Year 10 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2022 Year 12 Month 12 Day

Date analysis concluded



Other

Other related information

The following information will be collected from electronic medical records and incident reports for all inpatients aged 20 years and older admitted to the study sites during the target period.
At the time of the fall: location of the fall, date and time of the fall, reason for the fall, implemented fall prevention procedures, antipsychotic medication, Bedriddenness ranks and cognitive function scores at the time of the fall, incident/accident
On admission: ADL, Barthel Index, Bedriddenness ranks, Cognitive function scores, age, sex, emergency admission, admitted department, previous history of falls, use of hypnotic medication, ambulance transportation, referral letter, long-term care classification, disturbance of consciousness, BMI, self-management of medication, cataracts, glaucoma, paralysis due to stroke, lower extremity weakness, antipsychotic medicines, visual impairment, previous history of Parkinson's disease/syndrome, diabetes mellitus, dysphagia, use of walking assist devices, implemented fall prevention procedures on admission
At hospital discharge: date of admission, date of discharge, primary disease for admission, presence of falls during hospitalization, surgical operations performed during hospitalization, rehabilitation performed during hospitalization, outcome


Management information

Registered date

2021 Year 09 Month 08 Day

Last modified on

2024 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050831


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2023/03/20 20221212N 科研B転倒および転倒傷害データUMIN登録.xlsx