UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023056 |
|---|---|
| Receipt number | R000026575 |
| Scientific Title | Community Dwelling Elderly with Pre-dysphagia under the Risk of Aspiration in Unfamiliar Situation Including Disaster Shelters |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2020/01/09 14:38:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Community Dwelling Elderly with Pre-dysphagia under the Risk of Aspiration in Unfamiliar Situation Including Disaster Shelters
Acronym
Research for Pre-dysphagia Community Dwelling Elderly
Scientific Title
Community Dwelling Elderly with Pre-dysphagia under the Risk of Aspiration in Unfamiliar Situation Including Disaster Shelters
Scientific Title:Acronym
Research for Pre-dysphagia Community Dwelling Elderly
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how many community dwelling elderly people are under a risk of aspiration
Basic objectives2
Others
Basic objectives -Others
To analyse a questionnaire survey for LTCI office in Shinjuku ward, Tokyo, Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of people in a state of pre-dysphagia
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 200 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
LTCI service user who registers LTCI office in Shinjuku ward
Key exclusion criteria
none
Target sample size
2082
Research contact person
Name of lead principal investigator
| 1st name | Meigen |
| Middle name | |
| Last name | Liu |
Organization
Keio University School of Medicine
Division name
Dept. Rehabilitation Medicine
Zip code
1608582
Address
35 Shinano-machi Shinjuku-ku
TEL
03-5363-3833
meigenliekeio@icloud.com
Public contact
Name of contact person
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Dept. Rehabilitation Medicine
Zip code
1608582
Address
35 Shinano-machi Shinjuku-ku
TEL
03-5363-3833
Homepage URL
https://sites.google.com/a/saigaizaitaku.net/index/caremanet
s-tashiro@umin.net
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Keio University School of Medicine
Address
Shinano-machi 35
Tel
03-3353-1211
rinri@keio.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
not yet decided
Org. issuing International ID_1
Keio university
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
http://www.keiorehab.jp/
Publication of results
Published
Result
URL related to results and publications
http://www.keiorehab.jp/
Number of participants that the trial has enrolled
1271
Results
Data were acquired from 1,271 care recipients. Notably, 23.1% of the sampled
population had special needs regarding food intake at all times (e.g., non-oral intake or
need for texture-modified foods). An additional 11.5% were estimated to experience
difficulty when ingesting common emergency foods, despite the ability to consume
regular foods.
Results date posted
| 2020 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Community-dwelling elderly care recipients who were certified by
the public long-term care insurance system in Japan and registered at one of 77 care
managing offices in Shinjuku city.
Participant flow
Through the LTCI offices in Shinjuku city
Adverse events
N/A
Outcome measures
Special needs regarding food intake and risks associated with receiving
emergency foods were assessed by government-certified care managers.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2020 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026575
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
