UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040084 |
|---|---|
| Receipt number | R000045704 |
| Scientific Title | Development of a Conference Model after the 18-months-old Children Health Checkup for the Solution to Community Health Needs |
| Date of disclosure of the study information | 2020/04/07 |
| Last modified on | 2023/04/25 17:25:49 |
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Basic information
Public title
Development of a Conference Model after the 18-months-old Children Health Checkup for the Solution to Community Health Needs
Acronym
Development of a Conference Model after the 18-months-old Children Health Checkup for the Solution to Community Health Needs
Scientific Title
Development of a Conference Model after the 18-months-old Children Health Checkup for the Solution to Community Health Needs
Scientific Title:Acronym
Development of a Conference Model after the 18-months-old Children Health Checkup for the Solution to Community Health Needs
Region
| Japan |
Condition
Condition
Healthy individuals(Public Health Nurse)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development a Conferrence Model after tha 18-months-old chilrens Health Checkup Examining a Healty Needs Effectively
As a preliminary survey,we will prepare a conference form to be introduced at the conference after a Health cheackup and examine the management method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Evaiuate arter at least 12 test conferences using a conference form tentative plan and the progress guide;Resolution of Community Health Needs and effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Evaiuate arter at least 12 test confarences using a conference form tentative plan and progress guide. It is four times from once a month.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Local Public Health nurses in Yamaguchi Prefecture who are conducting Health Checkup for 18 months old chiidren by the local goverment alone in acomplete group Health Checkup system and participating in conferences sfter the Health checkup
Key exclusion criteria
Public health nurses dispatched from other organizations
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | MIYAKO |
| Middle name | |
| Last name | SAITO |
Organization
School Health Siences Yamaguchi University Graduate School of Medicine
Division name
Community/Gerontological Nursing
Zip code
755-8505
Address
1-1-1 MInami Kogushi,Ube Yamaguchi
TEL
0836-22-2826
msaito@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | MIYAKO |
| Middle name | |
| Last name | SAITO |
Organization
School Health Siences Yamaguchi University Graduate School of Medicine
Division name
Community/Gerontological Nursing
Zip code
755-8505
Address
1-1-1 MInami Kogushi,Ube Yamaguchi
TEL
0836-22-2826
Homepage URL
msaito@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi Univercity
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School Health Siences Yamaguchi University Graduate School of Medicine
Address
1-1-1 MInami Kogushi,Ube Yamaguchi
Tel
0836-22-2132
me202@yamaguchi-u.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
市町保健センター（山口県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
https://www.c-linkage.co.jp/jsph80/information.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.c-linkage.co.jp/jsph80/information.html
Number of participants that the trial has enrolled
10
Results
A conference sheet and a facilitator's guide developed by the researcher were used 13 times at a conference held after the 1-6 month health checkup in City A. As a result, not only individual support was discussed, but some of the community health issues were clarified. It was confirmed that the sheets can be used to accumulate and consolidate health issues, and can be utilized to improve the project.
Results date posted
| 2023 | Year | 04 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Public health nurses in City A conducting health checkups for children aged 1 year and 6 months using the group health checkup method.
Participant flow
Municipalities in Yamaguchi Prefecture that conduct health examinations for children aged 1 year and 6 months using the group health examination method were asked to cooperate in the study. As a result, we asked the heads of the municipalities who were willing to participate in the survey, and obtained consent for research cooperation from the public health nurses who were in charge of health examinations of one and a half year olds.
Adverse events
nothing
Outcome measures
1) Inhibiting and facilitating factors for the techniques used by public health nurses to develop their perspectives from individual issues to community issues through the introduction of a conference after the health checkup for children aged one and six months (community issue finding conference) to solve community health issues: An integrated framework for implementation research (CFIR)
(2) Changes in the perceptions of participating public health nurses
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The public health nurse of the local govermment carries out conference using a conference form tentative plan with the progress guide which researchers created.(In 1 local govermment 12 times or more)
The researcher take part in the conference and I participate and observe next item 1 meter or more from a participant at a remote place.The date and time,the type of job,progress method,expression and action of the participant,atmosphere of the place,remark contents,the time required.
Management information
Registered date
| 2020 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045704
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
