UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020739 |
|---|---|
| Receipt number | 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 10:37:24 |
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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
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
ksqdd034@yahoo.co.jp
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023929
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
