UMIN-CTR Clinical Trial

Basic information
Public title	Interobserver Agreement for the Assessment of observation in Dysphagia Patients
Acronym	Interobserver Agreement for the Assessment of observation in Dysphagia Patients
Scientific Title	Interobserver Agreement for the Assessment of observation in Dysphagia Patients
Scientific Title:Acronym	Interobserver Agreement for the Assessment of observation in Dysphagia Patients
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	This research is part of Development of guideline for determination of dysphagia's food type without using VF or VE.(KAKEN) Eight experts in this field consulted from the literature and actual situation survey and prepared a draft evaluation table (G evaluation table). This research confirms the consistency among the evaluators of each item of this G evaluation table. Since it is a non-expert on swallowing disorder that actually observes and evaluates in many places, it is necessary to verify whether such occupation can be observed and evaluated in the G evaluation table. This verification contributes to the improvement of the G evaluation table plan by confirming the items that are difficult to match among the evaluators. The consistency with the precision inspection of the G evaluation table is being confirmed by other studies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	*match rate *k coefficient *Interclass correlation coefficient
Key secondary outcomes	*non-match items detail *Intra-class correlation coefficient

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	*Person who work for dysphagia patients in daily work * Male and female over 20 years old **Person who has consented by written document
Key exclusion criteria	*Person who judged that the research representative is not appropriate for inclusion in research
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Junko Middle name Last name Fujitani
Organization	National Center for Global Health and Medicine
Division name	department of rehabilitation medicine
Zip code	162-8655
Address	Shinjuku-Ku
TEL	+81332027181
Email	jufujita@hosp.ncgm.go.jp

Public contact
Name of contact person	1st name Junko Middle name Last name Kikuchi
Organization	National Center for Global Health and Medicine
Division name	department of rehabilitation medicine
Zip code	162-8655
Address	Shinjuku-Ku
TEL	0332027181
Homepage URL
Email	kkikuchi@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine, National Center for Global Health and 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-shinsa@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（東京都）、日本歯科大学（東京都）、広島大学（広島）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 20 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	2019 Year 02 Month 20 Day
Date of IRB	2019 Year 02 Month 08 Day
Anticipated trial start date	2019 Year 02 Month 08 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information	Multicenter collaborative research

Management information
Registered date	2018 Year 12 Month 20 Day
Last modified on	2020 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040244