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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046653
Receipt No. 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

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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
Institute Kurume University School of Medicine
Institute
Department

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
URL(English) 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


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