UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045420 |
|---|---|
| Receipt number | R000050831 |
| Scientific Title | A Validation and practical application research of the predictive model for falls among inpatients using bedriddenness ranks in various medical institutions |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2024/10/18 11:46:55 |
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Basic information
Public title
A Validation and practical application research of the predictive model for falls among inpatients using Japanese public ADL scale in various medical institutions
Acronym
A Validation and practical application research of the predictive model for falls among inpatients
Scientific Title
A Validation and practical application research of the predictive model for falls among inpatients using bedriddenness ranks in various medical institutions
Scientific Title:Acronym
A Validation and practical application research of the predictive model for falls among inpatients
Region
| Japan |
Condition
Condition
Fall, Fall injury
Classification by specialty
| Medicine in general | Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To validate two predictive models which we developed for falls and fall injury among inpatients, and develop a system for practical use.
2. To evaluate the criterion-related validity of Bedriddenness Rank with other established objective scales of ADLs, and Cognitive Function Score with those of cognitive impairment.
3. To validate two predictive models which we developed for falls and fall injury among inpatients in each facility and each type of medical facility.
Basic objectives2
Others
Basic objectives -Others
The discrimination of tow models are evaluated by AUC and Calibration coefficient. Criterion-related validity are evaluated by Spearman's correlation coefficient.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inpatients' falls during hospitalization
Key secondary outcomes
Fall injury, Katz index, MMSE
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All adult inpatients
Sub Analysis: All adult inpatients in long-term care hospitals
Key exclusion criteria
Patients who do not give consent to the study
Target sample size
7818
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima Saga, Saga, Japan
TEL
0952-34-3238
tagomas@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | E |
| Last name | Katsuki |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima Saga, Saga, Japan
TEL
0952-34-3238
Homepage URL
d4180@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
CRINICAL RESEARCH CENTER, SAGA UNIVERSITY HOSPITAL
Address
5-1-1 Nabeshima, Saga, Saga, Japan
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.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
佐賀大学医学部付属病院（佐賀県）、佐賀県医療センター好生館（佐賀県）、独立行政法人国立病院機構嬉野医療センター（佐賀県）、社会医療法人祐愛会織田病院（佐賀県）、唐津市民病院きたはた（佐賀県）、医療法人長生会島田病院（佐賀県）、地方独立行政法人静岡県立病院機構静岡県立総合病院（静岡県）、国保国吉病院組合いすみ医療センター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 15 | 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
144770
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
We need additional time for data collection and writing the article.
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
Main results already published
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 12 | Month | 12 | Day |
Date analysis concluded
Other
Other related information
The following information will be collected from electronic medical records and incident reports for all inpatients aged 20 years and older admitted to the study sites during the target period.
At the time of the fall: location of the fall, date and time of the fall, reason for the fall, implemented fall prevention procedures, antipsychotic medication, Bedriddenness ranks and cognitive function scores at the time of the fall, incident/accident
On admission: ADL, Barthel Index, Bedriddenness ranks, Cognitive function scores, age, sex, emergency admission, admitted department, previous history of falls, use of hypnotic medication, ambulance transportation, referral letter, long-term care classification, disturbance of consciousness, BMI, self-management of medication, cataracts, glaucoma, paralysis due to stroke, lower extremity weakness, antipsychotic medicines, visual impairment, previous history of Parkinson's disease/syndrome, diabetes mellitus, dysphagia, use of walking assist devices, implemented fall prevention procedures on admission
At hospital discharge: date of admission, date of discharge, primary disease for admission, presence of falls during hospitalization, surgical operations performed during hospitalization, rehabilitation performed during hospitalization, outcome
Management information
Registered date
| 2021 | Year | 09 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050831
