UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040797
Receipt number R000046577
Scientific Title verification of effective health guidance to prevent aggravation by public health nurse
Date of disclosure of the study information 2020/06/22
Last modified on 2021/06/20 17:34:55

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Basic information

Public title

verification of effective health guidance to prevent aggravation by public health nurse

Acronym

verification of effective health guidance to prevent aggravation by public health nurse

Scientific Title

verification of effective health guidance to prevent aggravation by public health nurse

Scientific Title:Acronym

verification of effective health guidance to prevent aggravation by public health nurse

Region

Japan


Condition

Condition

Lifestyle diseases

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to briefly verify the effect of health guidance for prevention of aggravation.

Basic objectives2

Others

Basic objectives -Others

Efficacy

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fluctuation of blood glucose level for 2 weeks.

Key secondary outcomes

A diary of what I ate.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Health guidance

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

40 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

1.Persons with HbA1c of 6.5-7.0% or more as a result of physical examination and who were followed up after seeing a hospital.
2.As a result of health examination, HbA1c is targeted for 6.5% or more.
3.A person who has a HbA1c of 6.5% or less and is suspected of having high insulin as a result of a medical examination.

Key exclusion criteria

Excludes people with weak skin and those using pacemakers.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Mikiko
Middle name
Last name Kudo

Organization

Sophia University

Division name

Department of Nursing

Zip code

161-8550

Address

16-11, 4-chome, Shimo-Ochiai, Shinjuku-ku, Tokyo

TEL

03-3950-0171

Email

mikiko-kudo@sophia.ac.jp


Public contact

Name of contact person

1st name Mikiko
Middle name
Last name Kudo

Organization

Sophia University

Division name

Department of Nursing

Zip code

161-8550

Address

16-11, 4-chome, Shimo-Ochiai, Shinjuku-ku, Tokyo

TEL

03-3950-0171

Homepage URL


Email

mikiko-kudo@sophia.ac.jp


Sponsor or person

Institute

Sophia University

Institute

Department

Personal name



Funding Source

Organization

Sophia University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sophia University

Address

16-11, 4-chome, Shimo-Ochiai, Shinjuku-ku, Tokyo

Tel

03-3950-0171

Email

mikiko-kudo@sophia.ac.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

北海道釧路市


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 22 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

Enrolling by invitation

Date of protocol fixation

2020 Year 01 Month 31 Day

Date of IRB

2020 Year 02 Month 25 Day

Anticipated trial start date

2020 Year 06 Month 20 Day

Last follow-up date

2021 Year 08 Month 17 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 06 Month 30 Day

Date analysis concluded

2022 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 06 Month 17 Day

Last modified on

2021 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046577


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name