UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034329 |
|---|---|
| Receipt number | R000038343 |
| Scientific Title | The reliability and validity of a Japanese diabetes knowledge test. |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/10/02 21:20:33 |
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Basic information
Public title
The reliability and validity of a Japanese diabetes knowledge test.
Acronym
The reliability and validity of a Japanese diabetes knowledge test.
Scientific Title
The reliability and validity of a Japanese diabetes knowledge test.
Scientific Title:Acronym
The reliability and validity of a Japanese diabetes knowledge test.
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the reliability and validity of a Japanese diabetes knowledge test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To calculate Cronbach's coefficient alpha of a Japanese diabetes knowledge test (JDKT) in patients with type 2 diabetes
Key secondary outcomes
To examine whether patients show the same JDKT scores if they are not taught diabetes knowledge.
To examine whether patients show better KDKT scores after hospitalization than before
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.over 20 years old
2.who are able to answer the written questionnaire
3.who are able to give oral informed consent
Key exclusion criteria
1.dementia
2.history of stroke
3.psychiatric conditions, such as depression,schizophrenia, developmental disorder, or attention deficit hyperactivity disorder
4.diabetic ketoacidosis
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Minami |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-8503
Address
3-2-10,Konandai Konan-ku, Yokohama City, kanagawa, 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 Yokohamashi Nanbu Hospital
Division name
Diabetes and Endocrinology
Zip code
234-8503
Address
3-2-10,Konandai Konan-ku, Yokohama City, kanagawa, Japan
TEL
045-832-1111
Homepage URL
hiiragihiroko@gmail.com
Sponsor or person
Institute
Saiseikai Yokohamashi 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
Odawara Municipal Hospital, Yokohama Sakae kyosai hospital, Minagawa Medical Clinic,H.E.C Science Clinic, Iemitu Clinic, Konandai Medical Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Yokohamashi Nanbu Hospital
Address
3-2-10,Konandai Konan-ku, Yokohama City, kanagawa 234-0054,Japan
Tel
045-832-1111
ke-somu@city.odawara.kanagawa.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
| 2018 | Year | 10 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | 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.
Inpatients with type 2 diabetes will be administered JDKT twice; on admission and before discharge. Then we will evaluate the improvement of JDKT scores, teaching them diabetes knowledge. When inpatients take JDKT, they will not be taught the answers of JDKT.
Outpatients with type 2 diabetes will also be administered JDKT twice within 8 weeks. Then we will investigate whether they show similar JDKT test scores, without teaching them diabetes knowledge, using intraclass correlation coefficient.
Japanese diabetes knowledge test URL:http://www.city.odawara.kanagawa.jp/global-image/units/358806/1-20180807183200.pdf
Management information
Registered date
| 2018 | Year | 09 | Month | 29 | Day |
Last modified on
| 2021 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038343
