UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048398 |
|---|---|
| Receipt number | R000055164 |
| Scientific Title | The Influences of Hypnotics or Sedatives on Aspiration Pneumonia and Hip Fracture in Community Dwelling Older Japanese Adults |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2022/07/18 15:51:24 |
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Basic information
Public title
The Influences of Hypnotics or Sedatives on Aspiration Pneumonia and Hip Fracture in Community Dwelling Older Japanese Adults
Acronym
The Influences of Hypnotics or Sedatives in Community Dwelling Older Japanese Adults
Scientific Title
The Influences of Hypnotics or Sedatives on Aspiration Pneumonia and Hip Fracture in Community Dwelling Older Japanese Adults
Scientific Title:Acronym
The Influences of Hypnotics or Sedatives in Community Dwelling Older Japanese Adults
Region
| Japan |
Condition
Condition
geriatrics
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to assess influences of hypnotics or sedatives on aspiration pneumonia, hip fracture and mortality in the target population.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
New diagnoses of aspiration pneumonia, hip fracture, and all-cause mortality
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Old adults (age 75 or older) who resided in Hokkaido Prefecture, Japan at April 1st, 2016
Key exclusion criteria
Regular use of CNS drugs except hypnotics or sedatives (n=45309)
History of hospital admission from 04/2016 to 09/2016 (n=86725)
Chronic dialysis patients (n=2819)
Certification of needed long term care (n=49019)
The following diagnosis by the end of 09/2016
1. Malignant neoplasm (n=254284), 2. Dementia (n=10681)
3. Depression (n=13193)
# There are overlapped subjects
Target sample size
249572
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Handa |
Organization
Medical Corporation Folkmore
Division name
Clinic Ian South Center
Zip code
2240032
Address
40-3, Chigasaki-cyuou, tuzuki-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL
045-945-1125
nobuhiro.handa@c-ian.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Handa |
Organization
Medical Corporation Folkmore
Division name
Clinic Ian South Center
Zip code
2240032
Address
40-3, Chigasaki-cyuou, tuzuki-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL
045-945-1125
Homepage URL
nobuhiro.handa@c-ian.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review Board, Tokyo Metropolitan Institute of Gerontology
Address
35-2, Sakae-cyo, Itabashi-ku, Tokyo, Japan
Tel
03-3964-3241
rinsyoushiken@tmghig.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
| 2022 | Year | 07 | Month | 20 | 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
66190
Results
RESULTS
During 42 months of follow-up period, the incidences of aspiration pneumonia, hip fracture and mortality in hypnotics group were significantly increased compared with the control groups. Sensitivity analyses utilizing inverse probability weighing demonstrated Hazard ratio: 1.083 [1.023-1.146] in mortality, 1.117 [1.014-1.230] in aspiration pneumonia, 1.720 [1.559-1.897] in hip fracture. Meanwhile, attribute risk difference were 1.8, 1.5 and 1.0 per 1000 patient-year
Results date posted
| 2022 | Year | 07 | Month | 18 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Under writing a paper
Date of the first journal publication of results
Baseline Characteristics
Old adults (75 years old or older) who reside in Hokkaido Prefecture, Japan
Participant flow
Observation period (July 2016 to September 2916)to identify subjects who had regular use of hypnotics-sedatives
Subsequently, 42 months of follow-up
Adverse events
Hip fracture
Aspiration pneumonia
Death
Outcome measures
Hip fracture
Aspiration pneumonia
Death
Plan to share IPD
Prohibited to share patient level data by Local Government of Hokkaido Prefecture, Japan
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 17 | Day |
Other
Other related information
Retrospective cohort study was performed over 42 months from October 2016 to March 2020.
Management information
Registered date
| 2022 | Year | 07 | Month | 18 | Day |
Last modified on
| 2022 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055164
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