UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040536 |
|---|---|
| Receipt number | R000046261 |
| Scientific Title | Development of remote swallowing screening test using web conference system |
| Date of disclosure of the study information | 2020/05/27 |
| Last modified on | 2022/11/29 07:53:36 |
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Basic information
Public title
Development of remote swallowing screening test using web conference system
Acronym
Development of remote swallowing screening test
Scientific Title
Development of remote swallowing screening test using web conference system
Scientific Title:Acronym
Development of remote swallowing screening test
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of reliability and validity of remote swallow screening
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verification of reliability and validity of remote swallow screening
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
To perform remote swallowing screening for the elderly and patients with dysphagia
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
General elderly people who are registered at the Silver Human Resource Center
Dysphagia patients undergoing hospitalization or outpatient rehabilitation
Key exclusion criteria
Those who have not taken orally
Persons with severe visual or hearing impairment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Omori |
| Middle name | |
| Last name | Fumitaka |
Organization
Fukuoka Dental College Hospital
Division name
Department of Otorhinolaryngology
Zip code
814-0193
Address
2-15-1,Tamura,Sawara-ku,Fukuoka
TEL
0928010411
omori@college.fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | Omori |
| Middle name | |
| Last name | Fumitaka |
Organization
Fukuoka Dental College Hospital
Division name
Department of Otorhinolaryngology
Zip code
814-0193
Address
2-15-1,Tamura,Sawara-ku,Fukuoka
TEL
0928010411
Homepage URL
omori@college.fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
The Soda Toyoji Memorial Foundation
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
Fukuoka Dental College
Address
2-15-1,Tamura,Sawara-ku,Fukuoka
Tel
0928010411
shomu@college.fdcnet.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-20K19366/
Publication of results
Unpublished
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-20K19366/
Number of participants that the trial has enrolled
80
Results
The alpha coefficient for the items was 0.878. There was a high correlation between the total score of RED and MASA in the face-to-face condition. Inter-rater reliability in the face-to-face and remote conditions were good. Intra-rater reliability between face-to-face and remote conditions was also good.
Results date posted
| 2022 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Methods: The participants were 21 healthy elderly individuals and 72 postoperative oral cancer (OC) patients.
Participant flow
RED and MASA were administered to all participants under face-to-face condition, and only RED was administered remotely to 40 participants. OC patients underwent videofluoroscopic examination to identify aspiration and deglutition disorders, and the dysphagia severity score (DSS) was determined.
Adverse events
None.
Outcome measures
RED
MASA
VF
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | 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 | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046261
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
