UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053729 |
|---|---|
| Receipt number | R000061310 |
| Scientific Title | Development of Japanese version of Agitation in Alzheimer's Screener for Caregivers (AASCTM): a linguistic validity study. (Qualitative study using web-based interview) |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/02/28 14:56:21 |
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Basic information
Public title
Development of Japanese version of Agitation in Alzheimer's Screener for Caregivers (AASCTM): a linguistic validity study.
(Qualitative study using web-based interview)
Acronym
Development of Japanese version of Agitation in Alzheimer's Screener for Caregivers (AASCTM): a linguistic validity study
Scientific Title
Development of Japanese version of Agitation in Alzheimer's Screener for Caregivers (AASCTM): a linguistic validity study.
(Qualitative study using web-based interview)
Scientific Title:Acronym
Development of Japanese version of Agitation in Alzheimer's Screener for Caregivers (AASCTM): a linguistic validity study
Region
| Japan |
Condition
Condition
Alzheimer's Disease
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To introduce AASC into the clinical setting in Japan, as part of the development of the Japanese version of AASC, a linguistically valid Japanese translation will be created.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After obtaining responses to Japanese translated version of AASC, conduct an interview survey on the following aspects:
1
Is it generally easy to understand?
Is the time required for answering appropriate?
Is filling out the questionnaire difficult?
2
Is the explanatory text easy to understand?
How did you interpret the meaning of the question text?
3
Was the content of the questions easy to understand?
How did you interpret the meaning of the question content?
Is it difficult to answer the questions?
4
Are the answer choices clear and relevant to the questions?
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Individuals aged 18 or older.
2)Individuals who are primarily responsible for the care of a relative(s) with AD and formal caregivers who care for patient(s) with AD.
3)Individuals who comprehend Japanese and have the ability to respond to questionnaires and engage in face-to-face interviews.
4)Individuals who express a willingness to participate in the interview survey.
Key exclusion criteria
N/A
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamato |
Organization
Otsuka Pharmaceutical Co.,Ltd.
Division name
Medical Affairs
Zip code
108-8241
Address
Shinagawa Grand Central Tower 2-16-4 Konan,Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Yamato.Kentaro@otsuka.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamato |
Organization
Otsuka Pharmaceutical Co.,Ltd.
Division name
Medical Affairs
Zip code
108-8241
Address
Shinagawa Grand Central Tower 2-16-4 Konan,Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Yamato.Kentaro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co.,Ltd.
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
Otsuka Pharmaceutical Co.,Ltd. Research Department Research Ethics Committee
Address
10-463 Kagasuno Kawachi cho Tokushima city Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
| 2024 | Year | 03 | Month | 31 | 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
5
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
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 01 | 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
To introduce AASC into the clinical setting in Japan, as part of the development of the Japanese version of AASC, a linguistically valid Japanese translation will be created
Management information
Registered date
| 2024 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061310
| 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 |
