UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043052 |
|---|---|
| Receipt number | 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 | 2024/07/23 15:01:36 |
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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
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
shin.kitamura@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
| 2025 | Year | 06 | Month | 30 | Day |
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
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049149
