UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006473 |
|---|---|
| Receipt number | R000007683 |
| Scientific Title | Investigation for distribution and severity of patients with dysphagia with using dysphagia severity scale |
| Date of disclosure of the study information | 2011/10/04 |
| Last modified on | 2019/10/10 10:51:29 |
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Basic information
Public title
Investigation for distribution and severity of patients with dysphagia with using dysphagia severity scale
Acronym
Investigation for dysphagia Severity (IDyS)
Scientific Title
Investigation for distribution and severity of patients with dysphagia with using dysphagia severity scale
Scientific Title:Acronym
Investigation for dysphagia Severity (IDyS)
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Geriatrics | Surgery in general | Rehabilitation medicine |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To speculate the distribution and severity of the patients with dysphagia in Japan
Basic objectives2
Others
Basic objectives -Others
Investigation
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Dysphagia severity scale
Key secondary outcomes
Nutrition, Texture of food, Use and disuse of thickner
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
Dysphagia
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Toba |
Organization
National Center for Geriatrics and Gerontology
Division name
National Hospital for Geriatric Medicine
Zip code
4748511
Address
35, Gengo, Morioka-chou, Obu, Aichi
TEL
0562-46-2311
toba@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Eichi |
| Middle name | |
| Last name | Saitoh |
Organization
Fujita Health University
Division name
1st Department of Rehabilitation Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-chou, Toyoake, Aichi
TEL
0562-93-2000
Homepage URL
esaitoh@fujita-hu.ac.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Minister of Health and Labor
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430, Morioka-chou, Obu, Aichi
Tel
0562-46-2311
ik7710@ncgg.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
藤田保健衛生大学七栗サナトリウム
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
We will determine the number of patients with dysphagia and their severity with the stratification of function of hospital and institute for long-term care and speculate the total number of patients in Japan as compared to the statistics of the bed distribution presented by minister of health and labor.
Management information
Registered date
| 2011 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007683
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
