UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046653
Receipt number R000053214
Scientific Title Balance dysfunction the most significant cause of in-hospital falls in patients taking hypnotic drugs: A retrospective study
Date of disclosure of the study information 2022/01/17
Last modified on 2022/01/16 16:59:04

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Basic information

Public title

Association hypnotic drugs and falls: Examining the impact of hospital standard instructions

Acronym

Association hypnotic drugs and falls

Scientific Title

Balance dysfunction the most significant cause of in-hospital falls in patients taking hypnotic drugs: A retrospective study

Scientific Title:Acronym

Balance dysfunction the most significant cause of in-hospital falls in patients taking hypnotic drugs

Region

Japan


Condition

Condition

Fall in the acute hospital

Classification by specialty

Psychiatry Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to investigate the association between falls in hospitalized patients and the hypnotic drugs, balance ability.

Basic objectives2

Others

Basic objectives -Others

Each hypnotic drug fall rate

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

To discover the most influential factors associated with falls.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients taking hypnotic drugs

Key exclusion criteria

Patients can not stand or miss data about balance assessment

Target sample size

2840


Research contact person

Name of lead principal investigator

1st name Ryuki
Middle name
Last name Hashida

Organization

Kurume University

Division name

Department of Orthopaedics

Zip code

8300011

Address

67 Asahi-machi, Kurume, Fukuoka, Japan

TEL

+81-942-31-7568

Email

hashida_ryuuki@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name Ryuki
Middle name
Last name Hashida

Organization

Kurume University

Division name

Department of Orthopaedics

Zip code

8300011

Address

67 Asahi-machi, Kurume 830-0011, Japan

TEL

+81-942-31-7568

Homepage URL


Email

hashida_ryuuki@med.kurume-u.ac.jp


Sponsor or person

Institute

Kurume University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kurume University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kurume University School of Medicine

Address

67 Asahi-machi, Kurume 830-0011, Japan

Tel

0942-65-3749

Email

i_rinri@kurume-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



Other administrative information

Date of disclosure of the study information

2022 Year 01 Month 17 Day


Related information

URL releasing protocol

a

Publication of results

Published


Result

URL related to results and publications

a

Number of participants that the trial has enrolled

2840

Results

This study included 2840 patients taking hypnotics dug. Falls accidents were reported for 211 (7.4%) of 2860 inpatients taking hypnotic drugs. We analyzed to identify independent factors for falls, a decision tree algorithm was created using two divergence variables and classifying the patients into three groups. The SIDE levels were the initial divergence variable. Balance disorder was the initial divergence variable.

Results date posted

2022 Year 01 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

patients taking hypnotic drugs

Participant flow

patients taking hypnotic drugs

Adverse events

None

Outcome measures

Number of fall

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 04 Month 01 Day

Date of IRB

2021 Year 08 Month 27 Day

Anticipated trial start date

2020 Year 12 Month 31 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective stuudy


Management information

Registered date

2022 Year 01 Month 16 Day

Last modified on

2022 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053214


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2022/01/16 SIDE final data.xls