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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034330
Receipt No. R000038352
Scientific Title The effect of diabetes knowledge test scores on HbA1c levels in one year after hospitalization
Date of disclosure of the study information 2018/10/01
Last modified on 2019/04/02

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Basic information
Public title The effect of diabetes knowledge test scores on HbA1c levels in one year after hospitalization
Acronym The effect of diabetes knowledge test scores on HbA1c levels in one year after hospitalization
Scientific Title The effect of diabetes knowledge test scores on HbA1c levels in one year after hospitalization
Scientific Title:Acronym The effect of diabetes knowledge test scores on HbA1c levels in one year after hospitalization
Region
Japan

Condition
Condition patients with type 2 diabaetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether Japanese diabetes knowledge test scores have relationships with HbA1c levels in one year after hospitalization
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All patients will be divided into two groups with the median Japanese diabetes knowledge test (JDKT) score in the hospital. We will investigate the difference in HbA1c levels between patients with better JDKT scores and those with worse scores, in one year after hospitalization.
Key secondary outcomes

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 1.Patients with type 2 diabetes who required for hospitalization for the first time
2.Over 65 years old
3.Patients who are able to answered the questionnaires.
4.Diabetes duration are within 5 years
5.Patients who are able to give oral informed consent.
Key exclusion criteria 1. Patients with dementia
2. Patients with a history of stroke
3. Psychiatric disease which affects cognitive abilities such as depression
4. Diabetic ketoacidosis
5. Steroid users
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Uru
Middle name Nezu
Last name Osada
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 Amadeus@yokohama-cu.ac.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
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, 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 Open public recruiting
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
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 prospective cohort study.

Patients who showed better JDKT scores than a median score before discharge

Controls who showed worse JDKT scores than a median score before discharge

Main outcome: The difference in HbA1c levels at 12 months after hospitalization between the two groups

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
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038352

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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