UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032176 |
|---|---|
| Receipt number | 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 15:01:02 |
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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
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/
yoshioka.k.aa@niph.go.jp
Sponsor or person
Institute
Department of Health Promotion, National Institute of Public Health
Institute
Department
Personal name
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
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
Value
https://center6.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 |
