UMIN-CTR Clinical Trial

Basic information
Public title	Survey of falls in hospitalized patients and Validity of the assessment sheet to investigate the risk of falls. Development of assessment sheets with high fall prediction accuracy.
Acronym	Survey of falls in hospitalized patients and Validity of the assessment sheet to investigate the risk of falls. Development of assessment sheets with high fall prediction accuracy.
Scientific Title	Survey of falls in hospitalized patients and Validity of the assessment sheet to investigate the risk of falls. Development of assessment sheets with high fall prediction accuracy.
Scientific Title:Acronym	Survey of falls in hospitalized patients and Validity of the assessment sheet to investigate the risk of falls. Development of assessment sheets with high fall prediction accuracy.
Region	Japan

Condition
Condition	Any disease
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of a Falls Assessment Sheet with High Predictive Accuracy and Investigation of Its Utility.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity and specificity of the assessment sheet for the presence of falls based on one year of observation..
Key secondary outcomes	Number of falls Survival rate by fall risk Risk ratios for falls

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	1 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients admitted to this hospital
Key exclusion criteria	Patiens who did not evaluate the assessment sheet
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Tokuhisa
Organization	General hospital of Yuukoukai
Division name	Department of Rehabilitation
Zip code	567-0058
Address	1-25 Nisitoyokawacho Iabragi city Osaka prefecture
TEL	0726412488
Email	rehabili@yukoukai.com

Public contact
Name of contact person	1st name Kentaro Middle name Last name Tokuhisa
Organization	General hospital of Yuukoukai
Division name	Department of Rehabilitation
Zip code	567-0058
Address	1-25 Nisitoyokawacho Iabragi city Osaka prefecture
TEL	0726412488
Homepage URL
Email	rehabili@yukoukai.com

Sponsor
Institute	General hospital of Yuukoukai
Institute
Department

Funding Source
Organization	None
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	ethics committee of General hospital of Yukoukai
Address	1-25 Nisitoyokawacho Iabragi city Osaka prefecture
Tel	0726412488
Email	rehabil@yukoukai.com

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 11 Month 30 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	1450
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	2020 Year 04 Month 01 Day
Date of IRB	2021 Year 08 Month 27 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The observation period is one year, from April 1, 2020 to March 31, 2021. Comparison of different assessment methods.

Management information
Registered date	2022 Year 11 Month 30 Day
Last modified on	2022 Year 11 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056072