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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020739
Receipt No. R000023929
Scientific Title To investigate whether one-minute status examination for category fluency is useful to evaluate the ability of mastering insulin self-injection technique within 1 week
Date of disclosure of the study information 2016/02/01
Last modified on 2017/01/27

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Basic information
Public title To investigate whether one-minute status examination for category fluency is useful to evaluate the ability of mastering insulin self-injection technique within 1 week
Acronym To investigate whether one-minute status examination for category fluency is useful to evaluate the ability of mastering insulin self-injection technique within 1 week
Scientific Title To investigate whether one-minute status examination for category fluency is useful to evaluate the ability of mastering insulin self-injection technique within 1 week
Scientific Title:Acronym To investigate whether one-minute status examination for category fluency is useful to evaluate the ability of mastering insulin self-injection technique within 1 week
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the score of cognitive tests between inpatients with type2 diabetes who can master insulin self-injection technique within 1 week and those who can not, when they learn how to inject insulin for the first time
Basic objectives2 Others
Basic objectives -Others To investigate the cognitive tests which is useful to evaluate the ability of mastering insulin self-injection technique within 1 week
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the score of verbal fluency tests`the names of animals` between inpatients with type2 diabetes who can master insulin self-injection technique within 1 week and those who can not, when they learn how to inject insulin for the first time
Key secondary outcomes To compare the total number of verbal fluency tests:the common nouns which begine with `a`,`ka`and`si` between inpatients with type2 diabetes who can master insulin self-injection technique within 1 week and those who can not, when they learn how to inject insulin for the first time
To compare the score of MMSE(Minimental state examination) between the 2 groups

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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subject:inpatients with type 2 diabetes who can not master insulin self-injection technique within 1 week
Contorol: inpatients with type 2 diabetes who can master insulin self-injection technique within 1 week
Key exclusion criteria 1.The patients with history of stroke
2.The patients with psychiatry diseases which may represent cognitive dysfunctions such as depression
3.Diabetic ketoacidosis
4.Thyroid hormone disorders
5.Vitamin deficiency disorders
6.Patients with infectious diseases within 3 months
7.The individuals who stop to generate "the town they have visited" on vebal fluency tests within 1 minute
8.The individuals the attending doctor or the researcher judge inappropriate to be in this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayo Yamada
Organization Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Division name Department of Endocrinology & Metabolism
Zip code
Address Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan
TEL 045-891-2171
Email masayo-y@cameo.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minami Taichi
Organization Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
Division name Department of Endocrinology & Metabolism
Zip code
Address Katsura-chou 132, Sakae-ku, Yokohama, Kanagawa, Japan
TEL 045-891-2171
Homepage URL
Email ksqdd034@yahoo.co.jp

Sponsor
Institute Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
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
Address
Tel
Email

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
2016 Year 02 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
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cross-sectional study
The inpatients with type 2 diabetes who start insulin therapy for the first time will be divided into 2 groups.
The subjects are inpatients who can not master insulin self-injection technique within 1 week.
The controls are inpatients who can master insulin self-injection technique within 1 week.

Management information
Registered date
2016 Year 01 Month 26 Day
Last modified on
2017 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023929

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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