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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038745
Receipt No. 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 2019/11/30

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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
Email 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
Email hiiragihiroko@gmail.com

Sponsor
Institute Saiseikai Yokohama Nanbu Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 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
2019 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044114

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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