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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032176
Receipt No. R000036677
Scientific Title Developing educational program for middle-level public health nurses to create a new program which based on the community health needs: Randomized control trial(Second time)
Date of disclosure of the study information 2018/04/13
Last modified on 2019/04/01

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Basic information
Public title Developing educational program for middle-level public health nurses to create a new program which based on the community health needs: Randomized control trial(Second time)
Acronym Developing educational program for middle-level public health nurses to create a new program: Randomized control trial(Second time)
Scientific Title Developing educational program for middle-level public health nurses to create a new program which based on the community health needs: Randomized control trial(Second time)
Scientific Title:Acronym Developing educational program for middle-level public health nurses to create a new program: Randomized control trial(Second time)
Region
Japan

Condition
Condition No
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to develop educational program for middle-level public health nurses to create a new program based on the community health needs which were identified through daily practices.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The competency of public health nurses in public health policy scale
Competency measurement of creativity for public health nurse
Knowledge and attitude of program development
:Baseline, after intervention
Key secondary outcomes Networking practice of public health nurses: Baseline, after intervention
Evaluation of contents of web-based learning and face-to-face group sessions: After intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Participating web-based learning modules include 8 parts.
Interventions/Control_2 Person who want to join a face-to face group sessions after watching the web-based learning module 8.
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 The person who was the middle-level public health nurses and have worked as full-time staff at public administration.
PHNs who have years of experiences as municipal or prefectural public health nurse 5 - 20 years.
Key exclusion criteria The exclusion criteria was public health nurses above the level of unit chief and who joined this research in 2017.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Kyoko
Middle name
Last name Yoshioka-Maeda
Organization National Institute of Public Health
Division name Department of Health Promotion
Zip code 351-0197
Address Minami
TEL 048-458-6111
Email yoshioka.k.aa@niph.go.jp

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name Yoshioka-Maeda
Organization National Institute of Public Health
Division name Department of Health Promotion
Zip code 351-0197
Address Minami
TEL 048-458-6111
Homepage URL http://phn.s28.xrea.com/
Email yoshioka.k.aa@niph.go.jp

Sponsor
Institute Department of Health Promotion, National Institute of Public Health
Institute
Department

Funding Source
Organization Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor University of Hyogo
Chiba Prefectural University of Health Sciences
Name of secondary funder(s) No

IRB Contact (For public release)
Organization National Institute of Public Health
Address 2-3-6, Minami, Wako-shi, Saitama
Tel 0484586111
Email yoshioka.k.aa@niph.go.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 国立保健医療科学院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 13 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5941601/
Publication of results Partially published

Result
URL related to results and publications http://phn.s28.xrea.com/
Number of participants that the trial has enrolled 244
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 20 Day
Date of IRB
2018 Year 01 Month 30 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 01 Month 30 Day
Date analysis concluded
2019 Year 02 Month 20 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 10 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036677

Research Plan
Registered date File name
2019/04/01 2.0915倫理審査_計画書.pdf

Research case data specifications
Registered date File name
2019/04/01 02 H30科研データ.xlsx

Research case data
Registered date File name
2019/04/01 02 H30科研データ.xlsx


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