UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050160 |
|---|---|
| Receipt number | R000057078 |
| Scientific Title | Developing a scoring system of ICECAP for Japanese version |
| Date of disclosure of the study information | 2023/01/29 |
| Last modified on | 2024/01/31 19:13:00 |
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Basic information
Public title
Developing a scoring system of ICECAP for Japanese version
Acronym
Developing a scoring system of ICECAP for Japanese version
Scientific Title
Developing a scoring system of ICECAP for Japanese version
Scientific Title:Acronym
Developing a scoring system of ICECAP for Japanese version
Region
| Japan |
Condition
Condition
general population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a scoring system to convert the results of the Japanese version of ICECAP-A into utility values.
Basic objectives2
Others
Basic objectives -Others
not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is the ICECAP-A utility value conversion formula derived from the Best-Worst Scaling (BWS) results for 16 scenarios developed based on ICECAP.
Key secondary outcomes
(Demographic data)
Age, gender, education, place of residence, employment status, marital status, number of family members living together, household income, current medical history, medical history, etc.
(Clinical Scale)
ICECAPA
ICECAPO
EQ5D
Flourishing Scale
Satisfaction With Life Scale
Scale of Positive and Negative Experience
Perceived Stress Scale
Subjective Health Status
The mean and standard deviation of the above items are the secondary endpoints. Exploratory evaluation items include the identification of explanatory factors when each secondary evaluation item is used as the explanatory variable using multivariate analysis.
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
-General residents with Japanese nationality (no particular restrictions such as history of disease, etc.)
-18 years of age or older
-Those who understand the purpose of the survey and can give their consent.
-Able to conduct the survey on the Web (using an online conferencing system in a part of the survey)
Key exclusion criteria
Research subjects who meet the above selection criteria but who also meet the following conditions will be excluded from participation in this study.
-For candidate participants aged 65 years or older, those who score 20 or more points on the "Dementia Checklist".
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Sado |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
mitsusado@keio.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Sado |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
mitsusado@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Mitsuhiro Sado
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Economy, Trade and Industry
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
慶應義塾大学医学部
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 29 | 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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 01 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057078
| 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 |
