UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049644 |
|---|---|
| Receipt number | R000056072 |
| 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. |
| Date of disclosure of the study information | 2022/11/30 |
| Last modified on | 2022/11/30 01:12:49 |
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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
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
rehabili@yukoukai.com
Sponsor or person
Institute
General hospital of Yuukoukai
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056072
