UMIN-CTR Clinical Trial

Basic information
Public title	Development of educational program for medical professional on non-technical skills with preventing fall
Acronym	Development of educational program based on "Non-technical Skill Evaluation Scale for Falling Accident Prevention"(NTSEFP)survey result
Scientific Title	Development of educational program for medical professional on non-technical skills with preventing fall
Scientific Title:Acronym	Development of educational program based on "Non-technical Skill Evaluation Scale for Falling Accident Prevention"(NTSEFP)survey result
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will apply the "NTSEFP" studies in hospitals in order to obtain falling prevention situation.Based on those information we will develop an educational program for medical personnel.Then we will implement the program and evaluate its effectiveness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The numbers of fall accidents pre- and post- intervention of a fall-related accident prevention education program for medical personnel.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Education to prevent falls of inpatients for medical staff
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	None
Key exclusion criteria	None
Target sample size	500

Research contact person
Name of lead principal investigator	1st name MIsako Middle name Last name Kinoshita
Organization	Fukushima Medial University
Division name	Fundamental of Nursing
Zip code	960-1295
Address	1 Hikarigaoka Fukushima Japan
TEL	024-547-1869
Email	kinomi@fmu.ac.jp

Public contact
Name of contact person	1st name MIsako Middle name Last name Kinoshita
Organization	Fukushima Medial University
Division name	Fundamental of Nursing
Zip code	960-1295
Address	1 Hikarigaoka Fukushima Japan
TEL	024-547-1869
Homepage URL
Email	kinomi@fmu.ac.jp

Sponsor
Institute	Fukushima Medial University
Institute
Department

Funding Source
Organization	Fukushima Medial University
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukushima Medial University
Address	1 Hikarigaoka Fukushima Japan
Tel	024-547-1869
Email	kinomi@fmu.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	29265
Org. issuing International ID_1	Fukushima Medial University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 13 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
Results
Results date posted
Results Delayed
Results Delay Reason
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	No longer recruiting
Date of protocol fixation	2017 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date	2018 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 12 Day
Last modified on	2020 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035645