UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040103 |
|---|---|
| Receipt number | R000045659 |
| Scientific Title | Validation of a new predictive model for inpatient's fall using public ADL scale in Japan (Bedriddenness rank and cognitive function score);Two-center prospective observational study |
| Date of disclosure of the study information | 2020/04/08 |
| Last modified on | 2023/04/16 16:31:19 |
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Basic information
Public title
Development of a new predictive model for inpatient's fall using public ADL scale in Japan (Bedriddenness rank and cognitive function score)
Acronym
New predictive model for inpatient's fall using public ADL scale
Scientific Title
Validation of a new predictive model for inpatient's fall using public ADL scale in Japan (Bedriddenness rank and cognitive function score);Two-center prospective observational study
Scientific Title:Acronym
Validation of a new predictive model for inpatient's fall using public ADL scale in Japan;Two-center prospective observational study
Region
| Japan |
Condition
Condition
Adult inpatient
Classification by specialty
| Nursing | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validate the utility of the predictive fall model developed for risk assessment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fall during hospitalization
Key secondary outcomes
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
Adult inpatients
Key exclusion criteria
Patient who refused an agreement
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
TEL
0952-34-3238
tagomas@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga 849-8501, Japan
TEL
0952-34-3238
Homepage URL
tagomas@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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yuai-kai Foundation and Oda Hospital
Address
4306 Takatsuhara, Kashima, Saga 849-1311, Japan
Tel
0954-63-3275
renkei@yuai-hc.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/35428196/
Number of participants that the trial has enrolled
3757
Results
All 141(3.8%) among 3,551 patients had a fall. In univariate analysis, the group with falls was older, higher rates of patients admitted in emergency, admitted to departments of Internal medicine/Neurosurgery, used sleeping pills, fell previously, are independent in food intake. They had a different rates of falls by bedrriddenness rank (p<0.05). The AUC of the prediction model for falls in the whole patients, Oda, and Fuji Yamato were 0.793, 0.822 and 0.642, respectively.
Results date posted
| 2020 | Year | 10 | Month | 20 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
in press
Date of the first journal publication of results
| 2022 | Year | 04 | Month | 15 | Day |
Baseline Characteristics
125 falls occurred (3.5%), the median age (interquartile range) was 78 years (66-87), 47.9% were men, the median length of hospital stay (interquartile range) was 10 (5-18) days, and the incidence rate of falls was 2.25 per 1,000 patient-days.
Participant flow
During the study period 3,757 inpatients were eligible.
Adverse events
None
Outcome measures
Fall during hospitalization
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 20 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 01 | Day |
Other
Other related information
Age, gender, emergency admission, use of hypnotics, history of falls, Bedriddenness rank, cognitive function score, presence of referrals, and falls during hospitalization are obtained from the electronic medical record.
Management information
Registered date
| 2020 | Year | 04 | Month | 08 | Day |
Last modified on
| 2023 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045659
