UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049986 |
|---|---|
| Receipt number | R000056931 |
| Scientific Title | Influence factors in the length of hospital stay for aspiration pneumonia. |
| Date of disclosure of the study information | 2023/03/20 |
| Last modified on | 2024/01/12 10:51:03 |
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Basic information
Public title
Influence factors in the length of hospital stay for aspiration pneumonia.
Acronym
Influence factors in the length of hospital stay for aspiration pneumonia.
Scientific Title
Influence factors in the length of hospital stay for aspiration pneumonia.
Scientific Title:Acronym
Influence factors in the length of hospital stay for aspiration pneumonia.
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Pneumology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate factors associated with length of hospital stay for aspiration pneumonia.
Basic objectives2
Others
Basic objectives -Others
To analyze the difference between the number of days required for treatment of aspiration pneumonia and the length of hospital stay.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Age, sex, date of hospitalization, date of completion of antimicrobials, date of discharge
Key secondary outcomes
Living place before hospitalization, family composition before hospitalization, date of first interview with MSW, place of discharge, ADL before hospitalization, ADL at discharge, meal pattern at discharge, meal pattern at discharge Japan/complications
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with aspiration pneumonia selected on the DPC at discharge between January 1, 2020 and December 31, 2020
2)Cases who did not express their refusal to participate due to opting out
Key exclusion criteria
1)Cases with missing items to be collected
2)Cases who expressed their refusal to participate due to opting out
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
1628655
Address
1-21-1 toyama shinzyuku-ku,Tokyo
TEL
0332027181
jufujita@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Kikuchi |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
1628655
Address
1-21-1 toyama shinzyuku-ku,Tokyo
TEL
0332027181
Homepage URL
kkikuchi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Junko Fujitani
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
National Center for Global Health and Medicine
Address
1-21-1, toyama, shinjuku-ku, Tokyo
Tel
0332027181
rinrijm@hosp.ncgm.go.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
国立研究開発法人国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | 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
250
Results
Under analysis
Results date posted
| 2024 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Medical record information for hospitalized patients with aspiration pneumonia
Participant flow
We will retrospectively review the medical records of cases in which aspiration pneumonia was selected on DPC at discharge from January 1, 2020 to December 31, 2020.
Adverse events
None
Outcome measures
Age, gender, date of hospitalization, date of completion of antibiotics, date of discharge, living place before hospitalization, family structure living together before hospitalization, date of first interview with MSW, place of discharge, ADL before hospitalization, ADL at time of discharge, discharge Meal style at the time, date when the diet changed to the time at discharge, complications
Plan to share IPD
under consideration
IPD sharing Plan description
under consideration
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Data collection completed. Under analysis.
Management information
Registered date
| 2023 | Year | 01 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056931
| Research Plan | |
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