UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035320 |
|---|---|
| Receipt number | R000040244 |
| Scientific Title | Interobserver Agreement for the Assessment of observation in Dysphagia Patients |
| Date of disclosure of the study information | 2019/02/20 |
| Last modified on | 2020/06/22 08:26:14 |
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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
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
kkikuchi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine, National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040244
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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