UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038281 |
|---|---|
| Receipt number | R000043562 |
| Scientific Title | Prevalence and associated factors of sarcopenia dysphagia: multicenter database study |
| Date of disclosure of the study information | 2019/10/12 |
| Last modified on | 2022/10/15 05:25:34 |
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Basic information
Public title
Prevalence and associated factors of sarcopenia dysphagia: multicenter database study
Acronym
Prevalence and associated factors of sarcopenia dysphagia.
Scientific Title
Prevalence and associated factors of sarcopenia dysphagia: multicenter database study
Scientific Title:Acronym
Prevalence and associated factors of sarcopenia dysphagia: multicenter database study
Region
| Japan |
Condition
Condition
Patients aged 20 years or older with dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prevalence of dysphagia in sarcopenia other than in acute-care hospitals is unknown because there are no academic presentations or papers. Therefore, it is important to know the prevalence of eating and swallowing disorders in sarcopenia in a number of settings, including acute care hospitals, convalescent rehabilitation hospitals, elderly health facilities, and home care. Systemic sarcopenia and undernutrition are known to be associated with sarcopenia dysphagia, but other factors are unknown. A multicenter longitudinal study was designed to investigate the prevalence of eating and swallowing disorders in sarcopenia and the associated factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
severity of dysphagia
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older with dysphagia. FILS of 8 or less (I take three meals, except for those that are particularly difficult to eat.) between April 2018 and December 2020 are covered. Subjects are 20 years of age or older at the time of the first survey.
Key exclusion criteria
None
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Wakabayashi |
Organization
Yokohama City University Medical Center
Division name
Rehabilitaton medicine
Zip code
232-0024
Address
4 -57 Urafune-cho, Minami-ku, Yokohama-shi
TEL
045-261-5656
ntnyf092@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Wakabayashi |
Organization
Nihon University Hospital
Division name
Rehabilitation medicine
Zip code
232-0024
Address
4 -57 Urafune-cho, Minami-ku, Yokohama-shi
TEL
045-261-5656
Homepage URL
ntnyf092@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Medical Center
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
Yokohama City University Medical Center
Address
4 -57 Urafune-cho, Minami-ku, Yokohama-shi
Tel
045-261-5656
ntnyf092@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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 12 | 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
467
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Submission of thesis
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
Main results already published
Date of protocol fixation
| 2019 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational studies and multi-institutional database studies
Management information
Registered date
| 2019 | Year | 10 | Month | 12 | Day |
Last modified on
| 2022 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043562
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
