UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039694 |
|---|---|
| Receipt number | R000045274 |
| Scientific Title | Development of a new predictive model for falls among inpatients using the Japan MHLW bedriddenness rank in daily living |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2020/10/21 10:46:26 |
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Basic information
Public title
Development of a new predictive model for falls among inpatients using the Japan MHLW bedriddenness rank in daily living
Acronym
Development of predictive model for inpatients' fall
Scientific Title
Development of a new predictive model for falls among inpatients using the Japan MHLW bedriddenness rank in daily living
Scientific Title:Acronym
Development of predictive model for inpatients' fall
Region
| Japan |
Condition
Condition
Adult inpatients
Classification by specialty
| Nursing | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Few predictive formulas which have been developed previously are challenging to use because of their complexity. In this study, we develop and validate a new predictive model for falls in adult inpatients using the bedriddenness rank, which is easier to use than the formula previously reported.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inpatients' 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
All of adult inpatients
Key exclusion criteria
Patient who refused an agreement
Target sample size
9000
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
81-952-34-3238
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
81-952-34-3238
Homepage URL
tagomas@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yuai-kai Foundation and Oda Hospital
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 | 03 | Month | 04 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236130
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0236130
Number of participants that the trial has enrolled
7858
Results
7858 adult patents were available. Using model 1 consist of 13 factors, multivariate logistic regression analysis showed that the significant related factors were male, emergency admission, Department of Neurosurgery, use of hypnotic, previous falls, independent to eat, and bedriddenness rank. The AUC of model 1 was 0.808 in the test set, 0.789 in the validation set. For the model consisting of above 7 factors and age, the AUC was 0.806 in the test set, 0.787 in the validation set.
Results date posted
| 2020 | Year | 03 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Reject from journals
Date of the first journal publication of results
| 2020 | Year | 07 | Month | 16 | Day |
Baseline Characteristics
In the test set, 243 falls occurred (4.6%), the median age (interquartile range) was 77 years (62-85), 34% were men, the median length of hospital stay (interquartile range) was 9 (5-16) days, and the incidence rate of falls was 3.5 per 1,000 patient-days. In the validation set, 122 falls occurred (4.7%).
Participant flow
During the study period 8,343 inpatients were admitted, 8,031 of whom were aged 20 years or older. Among them, 7,858 were eligible , being randomly extracted to two groups, the test set (5,257) and the validation set (2,601).
Adverse events
None.
Outcome measures
The data in this study were extracted from the hospital's health records as follows. The variables on admission were age, sex (male and female), department of admission (Internal Medicine, Neurosurgery, or others), emergency admission (presence or absence), ambulance transfer (presence or absence), ADLs (ability to eat, go to the toilet, bathe, take prescribed medicines, and move independently), MHLW classifications for abilities of daily living, use of hypnotic medications (both benzodiazepine and non-benzodiazepine types; presence or absence), dependence on a wheelchair (presence or absence), admission with a referral letter from a primary physician (presence or absence), permanent residual damage from previous strokes, visual impairment, parkinsonism (presence or absence), and a history of falls (presence or absence).
Primary outcome, falls during hospitalization, were identified from the fall-specific report forms in the incident reports, which were mandatorily recorded and submitted by attending medical personnel when falls occurred during a hospital stay.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 02 | Month | 13 | Day |
Other
Other related information
Data including age, sex, activity of daily living, bedriddenness rank, cognitive function score in daily living, referral letter, hyptonic, previous fall, and emergency admission and fall during hospitalization were derived from hospital records.
Management information
Registered date
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2020 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045274
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/03/05 | 20150403ファイル結合転倒1追加4例.xlsx |
