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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006473
Receipt No. 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

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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
Email 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
Email esaitoh@fujita-hu.ac.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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