UMIN-CTR Clinical Trial

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
Email	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
Email	hiiragihiroko@gmail.com

Sponsor
Institute	Saiseikai Yokohamashi 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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038343