UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052362 |
|---|---|
| Receipt number | R000055685 |
| Scientific Title | Cohort study on fall risk with new bundles of standardized hypnotic administration |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/09/30 21:15:13 |
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Basic information
Public title
The evaluation of standardized hypnotic administration bundles against fall risk
Acronym
The evaluation of standardized hypnotic administration bundles against fall risk
Scientific Title
Cohort study on fall risk with new bundles of standardized hypnotic administration
Scientific Title:Acronym
COBATON study
Region
| Japan |
Condition
Condition
falls
Classification by specialty
| Geriatrics | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Benzodiazepine receptor agonists have been shown to be a risk for falls and fractures. The initiation of hypnotics while hospitalization carries a risk of continuing the medication even after discharge. Benzodiazepines are still the common prescription for insomnia, but few studies have shown that changes in hypnotic prescriptions have reduced the risk of falls and fractures.
Basic objectives2
Others
Basic objectives -Others
As the elderly age, their mobility and muscle strength decline, making them more prone to fall. Benzodiazepine receptor agonists are well-known drugs associated with the risk of falls in the elderly. The aim of this study was to clarify the impact of changes in prescriptions of hypnotics, especially interventions on prescriptions of BZDs, on fall risk in acute care hospitals in Japan.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total number of falls
Key secondary outcomes
A level change of fall rate, hypnotic-related falls and injury incidences
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 admitted to all departments in Saitama Citizens Medical Center
Key exclusion criteria
Patients admitted to department of pediatrics in Saitama Citizens Medical Center
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Yoshino |
Organization
Department of Internal Medicine, Saitama Citizens Medical Center
Division name
Division of General Internal Medicine
Zip code
3310054
Address
Shimane 299-1, Nishi-ku, Saitama-shi, Saitama, Japan
TEL
0486260011
yy_yopi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Yoshino |
Organization
Department of Internal Medicine, Saitama Citizens Medical Center
Division name
Division of General Internal Medicine
Zip code
3310054
Address
299-1 Shimane, Nishi-ku, Saitama-shi, Saitama, Japan
TEL
0486260011
Homepage URL
https://www.scmc.or.jp/
yy_yopi@yahoo.co.jp
Sponsor or person
Institute
Saitama Citizens Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Citizens Medical Center
Address
299-1 Shimane, Nishi-ku, Saitama-shi, Saitama, Japan
Tel
0486260011
yy_yopi@yahoo.co.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
さいたま市民医療センター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | 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
1761
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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2023 | Year | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055685
