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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038741
Receipt No. R000044170
Scientific Title Comparing investigation for HbA1c level one year later Hospital Diabetes Educational Program in elderly diabetes patients with social participation to without it.
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/29

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Basic information
Public title Comparing investigation for HbA1c level one year later Hospital Diabetes Educational Program in elderly diabetes patients with social participation to without it.
Acronym Comparing investigation for HbA1c level one year later Hospital Diabetes Educational Program in elderly diabetes patients with social participation to without it.
Scientific Title Comparing investigation for HbA1c level one year later Hospital Diabetes Educational Program in elderly diabetes patients with social participation to without it.
Scientific Title:Acronym Comparing investigation for HbA1c level one year later Hospital Diabetes Educational Program in elderly diabetes patients with social participation to without it.
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare HbA1c level one year later hospitalization inelderly diabetes patients with social paticipation to without it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will divide all patients into two groups by social participation.
Then one year later we will investigate the difference of HbA1c level.
Key secondary outcomes We will divide all patients into two groups by social participation.
Then one year later we will investigate the difference of weight change.

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 Aged 65 years or older patient with type 2 diabetes in-Hospital Diabetes Educational Program.
Key exclusion criteria Diabeic ketoacidosis
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Taichi
Middle name
Last name Minami
Organization Saiseikai Yokohama city Nanbu Hospital
Division name Diabetes and Endocrinology
Zip code 234-0054
Address 3-2-10,Konandai Konan-ku,Yokohama-shi,Kanagawa 234-0054 Japan
TEL 0458321111
Email ksqdd034@yahoo.co.jp

Public contact
Name of contact person
1st name Mayuko
Middle name
Last name Takahashi
Organization Saiseikai Yokohama city Nanbu Hospital
Division name Diabetes and Endocrinology
Zip code 234-0054
Address 3-2-10,Konandai Konan-ku,Yokohama-shi,Kanagawa 234-0054 Japan
TEL 0458321111
Homepage URL
Email kanagawa0320@gmail.com

Sponsor
Institute Saiseikai Yokohama city 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saiseikai Yokohama city Nanbu Hospital
Address 3-2-10,Konandai Konan-ku,Yokohama-shi,Kanagawa 234-0054 Japan
Tel 0458321111
Email soumu01@nanbu.saiseikai.or.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
2019 Year 12 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 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 to compare HbA1c level one year later in-hospital diabetes educational program of patients with social participation to patients without it.

Management information
Registered date
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044170

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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