UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034330 |
|---|---|
| Receipt number | 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 | 2022/05/03 13:28:21 |
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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
| 20 | 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 20 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
80
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
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
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
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
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
https://www.nanbu.saiseikai.or.jp/media/tounai-minami.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.nanbu.saiseikai.or.jp/media/tounai-minami.pdf
Number of participants that the trial has enrolled
79
Results
The inpatients who correctly answered questions about microangiopathy got better HbA1c levels than those who did incorrectly, at 48 weeks after discharge(p<0.05).
Results date posted
| 2022 | Year | 05 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inpatients with type 2 diabetes aged over 20 years old
Participant flow
We investigated the relationships between diabetes knowledge test scores and HbA1c levels at 48 weeks after discharge.
Adverse events
none
Outcome measures
The relationships between diabetes knowledge test scores and HbA1c levels at 48 weeks after discharge.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer 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
| 2022 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038352
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