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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034515
Receipt No. R000039275
Scientific Title Comparison between bedside evaluation and evaluation using equipment on dysphagia patient.
Date of disclosure of the study information 2018/12/17
Last modified on 2019/04/18

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Basic information
Public title Comparison between bedside evaluation and evaluation using equipment on dysphagia patient.
Acronym Comparison between bedside evaluation and evaluation using equipment on dysphagia patient.
Scientific Title Comparison between bedside evaluation and evaluation using equipment on dysphagia patient.
Scientific Title:Acronym Comparison between bedside evaluation and evaluation using equipment on dysphagia patient.
Region
Japan

Condition
Condition dysphagia
Classification by specialty
Oto-rhino-laryngology Rehabilitation medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 When a patient with dysphagia eats a certain food type, it compares with the result of VF or VE to ascertain how much the observation evaluation can correctly detect the symptoms.
Basic objectives2 Others
Basic objectives -Others Comparing the food type chosen in the observation evaluation table with the food type selected by VF or VE.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Eating observation evaluation by food type, VF or VE result
Key secondary outcomes Details when the result obtained from the observation evaluation table is different from the result of VF or VE

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
99 years-old >=
Gender Male and Female
Key inclusion criteria *A patient in charge who is diagnosed as having eating dysphagia and who is scheduled to perform VF for food form determination

*can be ingested orally

*Person who obtained written informed consent
Key exclusion criteria Those who have judged that the research director is inappropriate for incorporation into research
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Jnko
Middle name
Last name Fujitani
Organization National Center for Global Health and Medicine
Division name department of rehabilitation medicine
Zip code 162-8655
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL 0332027181
Email jufujita@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Juno
Middle name
Last name Fujitani
Organization National Center for Global Health and Medicine
Division name department of rehabilitation medicine
Zip code 162-8655
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL 0332027181
Homepage URL
Email jufujita@hosp.ncgm.go.jp

Sponsor
Institute National Center Golobal Health and Medicine
department of rehabilitation medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
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 Global Health and Medicine
Address 1-21-1 toyama shinjuku-ku Tokyo, Japan
Tel 0332027181
Email kenkyu-sinsa@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 国立国際医療研究センター 他

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 17 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 17 Day
Date of IRB
2018 Year 12 Month 28 Day
Anticipated trial start date
2018 Year 12 Month 28 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
2019 Year 05 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information multi-institutional joint research

Management information
Registered date
2018 Year 10 Month 16 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039275

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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