UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038720
Receipt number R000044121
Scientific Title To investigate whether all diabetic patients who participate in social activities will belong to category 1 of DASC-8 assessment or not.
Date of disclosure of the study information 2019/12/01
Last modified on 2022/06/07 12:17:46

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Basic information

Public title

To investigate whether all diabetic patients who participate in social activities will belong to category 1 of DASC-8 assessment or not.

Acronym

To investigate whether all diabetic patients who participate in social activities will belong to category 1 of DASC-8 assessment or not.

Scientific Title

To investigate whether all diabetic patients who participate in social activities will belong to category 1 of DASC-8 assessment or not.

Scientific Title:Acronym

To investigate whether all diabetic patients who participate in social activities will belong to category 1 of DASC-8 assessment or not.

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationships between social participation and DASC-8 scores.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We will divide all patients into 4 groups by social participation as well as DASC-8 categories.(i.e.,group1 vs group2 and group3)
Then we will investigate the bias among 4 groups using the chi square test.

Key secondary outcomes

We will divide all patients into 2 groups by social participation.Then we will investigate DASC-8 scores in two groups.


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,type2 diabetes hospitalization required for glycemic controls

Key exclusion criteria

Diabetic ketoacidosis

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Taichi
Middle name
Last name Minami

Organization

Saiseikai Yokohama Nanbu Hospital

Division name

Diabetes and Endocrinology

Zip code

234-8503

Address

3-2-10,Konandai Konan-ku,Yokohama City,kanagawa 234-0054 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 Yokohama Nanbu Hospital

Division name

Diabetes and Endocrinology

Zip code

234-8503

Address

3-2-10,Konandai Konan-ku,Yokohama City,kanagawa 234-0054 Japan

TEL

045-832-1111

Homepage URL


Email

hiiragihiroko@gmail.com


Sponsor or person

Institute

Saiseikai Yokohama 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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saiseikai Yokohama Nanbu Hospital

Address

3-2-10,Konandai Konan-ku,Yokohama City,kanagawa 234-0054 Japan

Tel

045-832-1111

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

Delay expected

Results Delay Reason

We are analyzing the data.

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

Enrolling by invitation

Date of protocol fixation

2019 Year 11 Month 20 Day

Date of IRB

2019 Year 12 Month 19 Day

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 cross-sectional study to investigate whether all diabetic patients who participate in social activities will belong to category 1 of DASC-8 assessment or not.


Management information

Registered date

2019 Year 11 Month 29 Day

Last modified on

2022 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044121


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name