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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032853
Receipt No. R000037464
Official scientific title of the study Education program for nurses under observation of swallowing by videoendoscopy
Date of disclosure of the study information 2018/06/03
Last modified on 2018/06/03

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Basic information
Official scientific title of the study Education program for nurses under observation of swallowing by videoendoscopy
Title of the study (Brief title) Education program for nurses under observation of swallowing by videoendoscopy
Region
Japan

Condition
Condition Patients with dysphagia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the feasibility of education program for nurses under the supervision of physician or dentist by using videoendoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ratio of nurses who passed the examination on the procedure of videoendoscopy at the thirtieth patients
Key secondary outcomes Concordance rate of swallowing function between nurses and physician or dentist
Adverse events at the procedures

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Education program under observation of swallowing by videoendoscopy
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

Not applicable
Gender Male and Female
Key inclusion criteria Nurses who are involved in the swallowing care.
Patients who gave informed consent on the procedure of videoendoscopy by nurse under the supervision of physician or dentist.
Key exclusion criteria Nurses who had experiences in procedure of videoendoscopy or education program for videoendoscopy
Target sample size 186

Research contact person
Name of lead principal investigator Eiichi Saitoh
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, School of Medicine
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-2167
Email esaitoh@fujita-hu.ac.jp

Public contact
Name of contact person Hitoshi Kagaya
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I, School of Medicine
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL 0562-93-2167
Homepage URL
Email hkagaya2@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo University
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 03 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 30 Day
Anticipated trial start date
2018 Year 06 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 03 Day
Last modified on
2018 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037464

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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