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
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
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
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
