UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Developing educational program for middle-level public health nurses to create a new program which based on the community health needs: Randomized control trial
Title of the study (Brief title)	Developing educational program for middle-level public health nurses to create a new program: Randomized control trial
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, 3 months thereafter
Key secondary outcomes	Networking practice of public health nurses: Baseline, after intervention, 3 months thereafter 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 6 parts.
Interventions/Control_2	Two-times face-to face group sessions after watching the web-based learning module 3 and 6.
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.
Target sample size	200

Research contact person
Name of lead principal investigator	Kyoko Yoshioka-Maeda
Organization	Tokyo Medical University
Division name	School of Nursing, Faculty of Medicine
Address	6-1-1, Shinjuku, Shinjuku-ku,Tokyo 160-8402
TEL	0333516141
Email	kyoko@tokyo-med.ac.jp

Public contact
Name of contact person	Kyoko Yoshioka-Maeda
Organization	Tokyo Medical University
Division name	School of Nursing, Faculty of Medicine
Address	6-1-1, Shinjuku, Shinjuku-ku,Tokyo 160-8402
TEL	0333516141
Homepage URL	http://phn.s28.xrea.com/
Email	kyoko@tokyo-med.ac.jp

Sponsor
Institute	School of Nursing, Faculty of Medicine, Tokyo Medical University
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	Japan

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

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	東京医科大学

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://phn.s28.xrea.com/
Results
Other related information

Management information
Registered date	2017 Year 03 Month 02 Day
Last modified on	2018 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030289