UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050939 |
|---|---|
| Receipt number | R000058051 |
| Scientific Title | Investigation of people with dysphagia who use home-visit nursing station living in serviced housing for the elderly. |
| Date of disclosure of the study information | 2023/04/26 |
| Last modified on | 2023/10/26 15:04:59 |
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Basic information
Public title
Investigation of people with eating problems
Acronym
IPEP
Scientific Title
Investigation of people with dysphagia who use home-visit nursing station living in serviced housing for the elderly.
Scientific Title:Acronym
IPDUHVNSLSHE
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the characteristics of those who have dysohagia among home-visit nursing station users living in elderly housing with services.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to investigate the effects of intervention by Speech-Language-Hearing Therapist.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Repetitive Saliva Swallowing Test(RSST) and Food Test(FT)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food Test
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Peole with dysphagia
Key exclusion criteria
Healthy people
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | SHOHEI |
| Middle name | |
| Last name | KOHRIYAMA |
Organization
Visiting Nursing Station Gakken Cocofump Nursing Okayama
Division name
Speech-Language-Hearing Therapist
Zip code
701-0211
Address
1207-3 Nishinagase Kitaku Okayama-shi
TEL
086-230-7785
kohriyama@kyudai.jp
Public contact
Name of contact person
| 1st name | SHOHEI |
| Middle name | |
| Last name | KOHRIYAMA |
Organization
Visiting Nursing Station Gakken Cocofump Nursing Okayama
Division name
Speech-Language-Hearing Therapist
Zip code
701-0211
Address
1207-3 Nishinagase Kitaku Okayama-shi
TEL
086-230-7785
Homepage URL
kohriyama@kyudai.jp
Sponsor or person
Institute
Visiting Nursing Station Gakken Cocofump Nursing Okayama
Institute
Department
Personal name
Funding Source
Organization
No organization
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School Hospital
Address
577 Matsushima Kurashiki-shi
Tel
086-462-1111
kenkyuhou2@med.kawasaki-m.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
| 2023 | Year | 04 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 04 | Month | 26 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058051
