UMIN-CTR Clinical Trial

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
Institute	Sophia University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046577