UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038745 |
|---|---|
| Receipt number | R000044114 |
| Scientific Title | Investigation of elderly diabetes patients who need DASC-8 assessment |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2023/06/03 10:41:26 |
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Basic information
Public title
Investigation of elderly diabetes patients who need DASC-8 assessment
Acronym
Investigation of elderly diabetes patients who need DASC-8 assessment
Scientific Title
Investigation of elderly diabetes patients who need DASC-8 assessment
Scientific Title:Acronym
Investigation of elderly diabetes patients who need DASC-8 assessment
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether verbal fluency tests scores will predict DASC-8 scores.Verbal fluency is a test for patients,otherwise DASC-8 is one for family members.Therby verbal fluency tests are more convenient than DASC-8
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will divide all patients into two groups by the cut off score of DASC-8(i.e.,11points).We will compare the scores of verbal fluency tests among the two groups.
Key secondary outcomes
Correlation between each questionnaire scors of DASC-8 and verbal fluency tests scores.Cut-off score of verbal fluency tests predicting DASC-8 cut-off score (i.e.,11 points).
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 65 years older,type2 diabetes,hospitalization required for glycemic controls
Key exclusion criteria
Diabetic ketoacidosis
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Minami |
Organization
Saiseikai Yokohama Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-8503
Address
3-2-10,Konandai Konan-ku,Yokohama City,kanagawa 234-0054 Japan
TEL
045-832-1111
ksqdd034@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Hiiragi |
Organization
Saiseikai Yokohama Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-8503
Address
3-2-10,Konandai Konan-ku,Yokohama City,kanagawa 234-0054 Japan
TEL
045-832-1111
Homepage URL
hiiragihiroko@gmail.com
Sponsor or person
Institute
Saiseikai Yokohama Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohama Nanbu Hospital
Address
3-2-10,Konandai Konan-ku,Yokohama City,kanagawa 234-0054 Japan
Tel
045-832-1111
soumu01@nanbu.saiseikai.or.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
| 2019 | Year | 12 | Month | 01 | 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
| 2019 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional study to investigate elderly diabetes patients who need DASC-8 assessment.A distribution of the Verbal fluency tests scores has a normal distribution.We will use verbal fluency test,which included recalling animal names and common nouns starting with the letters'a','ka','shi'(Japanese letters).We evaluate three scores of verbal fluency test,one is total number of animal names,another is total number of three common nouns the other is total number of both animal names and common nouns.
Management information
Registered date
| 2019 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044114
