UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029943 |
|---|---|
| Receipt number | R000034204 |
| Scientific Title | Predictive factors for achieving oral intake in elderly patients with aspiration pneumonia: videofluoroscopic evaluation of swallowing function. |
| Date of disclosure of the study information | 2017/11/13 |
| Last modified on | 2017/11/13 00:58:03 |
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Basic information
Public title
Predictive factors for achieving oral intake in elderly patients with aspiration pneumonia: videofluoroscopic evaluation of swallowing function.
Acronym
Predictive factors for achieving oral intake in elderly patients with aspiration pneumonia
Scientific Title
Predictive factors for achieving oral intake in elderly patients with aspiration pneumonia: videofluoroscopic evaluation of swallowing function.
Scientific Title:Acronym
Predictive factors for achieving oral intake in elderly patients with aspiration pneumonia
Region
| Japan |
Condition
Condition
Aspiration Pneumonia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the predictive factors, including videofluoroscopic swallowing evaluation, for achieving oral intake in elderly patients with aspiration pneumonia.
Basic objectives2
Others
Basic objectives -Others
exmine the predictive factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acheivement of oral intake after 4 weeks from performing Videofluoroscopic evaluation of swallowing function
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Study participants were selected from among 246 consecutive patients who were aged over than 65 years hospitalized at Kawasaki municipal hospital from April 2012 through March 2014 due to aspiration pneumonia.
Key exclusion criteria
patients with alternative nutrition
patients who died during their hospital stay
patients who started to oral nutrition just after admission without evaluating detailed swallowing function
patients who didnt start oral intake by using bedside screening test
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mari Ito |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi Shinjuku ku Tokyo
TEL
0353633833
marippe419@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Ito |
Organization
Kawasaki municipal hospital
Division name
Department of Rehabilitation
Zip code
Address
12-1 Shinkawa tori Kawasaki ku Kawasaki city
TEL
0442335521
Homepage URL
marippe419@yahoo.co.jp
Sponsor or person
Institute
Kawasaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Municipal Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 11 | Month | 13 | 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
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
| 2016 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 13 | Day |
Date analysis concluded
Other
Other related information
Factors likely related with oral intake including swallowing, nutritional, metabolic and functional status, pneumonia severity and comorbidities were extracted from the medical record. Multiple logistic regression analysis was performed to identify independent predictive factors for acquisition of oral intake.
Management information
Registered date
| 2017 | Year | 11 | Month | 13 | Day |
Last modified on
| 2017 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034204
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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