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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043052
Receipt No. R000049149
Scientific Title Development of a new fall prevention strategy using a care staff support system in a subacute rehabilitation ward
Date of disclosure of the study information 2021/01/19
Last modified on 2021/01/19

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Basic information
Public title Development of a new fall prevention strategy using a care staff support system in a subacute rehabilitation ward
Acronym Development of a new fall prevention strategy using a care staff support system in a subacute rehabilitation ward
Scientific Title Development of a new fall prevention strategy using a care staff support system in a subacute rehabilitation ward
Scientific Title:Acronym Development of a new fall prevention strategy using a care staff support system in a subacute rehabilitation ward
Region
Japan

Condition
Condition None (All patients admitted during the study period)
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of a new fall prevention strategy using a care staff support system in a subacute rehabilitation ward
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Falls and fall-related injuries obtained from incident reports
Key secondary outcomes Images recorded when events such as falls occur

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are admitted to the subacute rehabilitation ward in Fujita Health University Hospital, are judged at the risk of falling by the physician in charge, and give consent to participate in the study.
Key exclusion criteria None
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Yohei
Middle name
Last name Otaka
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, School of Medicine
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-2167
Email yootaka@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Shin
Middle name
Last name Kitamura
Organization Fujita Health University
Division name Faculty of Rehabilitation, School of Health Sciences
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-9000
Homepage URL
Email shin.kitamura@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor NTT DATA Corporation
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Fujita Health University Institutional Review Board
Address 1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel 0562-93-2865
Email f-irb@fujita-hu.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 藤田医科大学(愛知県)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 19 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 Enrolling by invitation
Date of protocol fixation
2020 Year 09 Month 26 Day
Date of IRB
2020 Year 12 Month 21 Day
Anticipated trial start date
2021 Year 01 Month 19 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information For patients who are judged at the risk of falling, a sensing system will be installed around their beds in the hospital room, and a care staff support system will be used. Changes in the fall rate due to the installation of the system will be verified using analysis methods such as propensity scores, and changes in the burden of medical staff will be verified using questionnaires. Risky behaviors will be analyzed based on the relationships between sensing records and images, and events such as falls.

Management information
Registered date
2021 Year 01 Month 19 Day
Last modified on
2021 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049149

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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