UMIN-CTR Clinical Trial

Basic information
Public title	Education program for dysphagia rehabilitation on home visit treatment using Information and Communication Technology
Acronym	ICT Education program of home visit treatment
Scientific Title	Education program for dysphagia rehabilitation on home visit treatment using Information and Communication Technology
Scientific Title:Acronym	ICT Education program of home visit treatment
Region	Japan

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

Objectives
Narrative objectives1	Education of home visit treatment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	questionnaire
Key secondary outcomes	pre, post test

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	Using ICT(Information and Communication Technology), Subjects are shown clinical assessment for dysphagia patient in home visit situation, they perform diagnosis and decide the way of patient guidance.Term: about 2 hours.1 time.
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	18 years-old <=
Age-upper limit	39 years-old >=
Gender	Male and Female
Key inclusion criteria	Dental school student or Graduate school student. healthy subject
Key exclusion criteria	Visual and hearing impairment
Target sample size	4

Research contact person
Name of lead principal investigator	1st name Takatoshi Middle name Last name Iida
Organization	Kanagawa Dental University
Division name	Division of Medically Compromised Geriatric Dentistry
Zip code	2388570
Address	1-23 Owagacho Yokosuka City Kanagawa
TEL	0468228874
Email	t.iida@kdu.ac.jp

Public contact
Name of contact person	1st name Takatoshi Middle name Last name Iida
Organization	Kanagawa Dental University
Division name	Division of Medically Compromised Geriatric Dentistry
Zip code	2388570
Address	1-23 Owagacho Yokosuka City Kanagawa
TEL	0468228874
Homepage URL
Email	t.iida@kdu.ac.jp

Sponsor
Institute	Division of Medically Compromised Geriatric Dentistry, Department of Critical Care Medicine and Dentistry, Graduate School of Dentistry, Kanagawa Dental University
Institute
Department

Funding Source
Organization	Kanagawa Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kanagawa Dental University
Address	1-23 Owagacho Yokosuka City Kanagawa
Tel	0468228874
Email	t.iida@kdu.ac.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	神奈川歯科大学

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 23 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	15
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	No longer recruiting
Date of protocol fixation	2020 Year 02 Month 05 Day
Date of IRB	2020 Year 01 Month 21 Day
Anticipated trial start date	2020 Year 04 Month 25 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 21 Day
Last modified on	2020 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044992