UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026360
Receipt number R000030289
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
Date of disclosure of the study information 2017/04/01
Last modified on 2018/04/12 10:28:07

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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

Acronym

Developing educational program for middle-level public health nurses to create a new program: Randomized control trial

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

Scientific Title:Acronym

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

1st name
Middle name
Last name Kyoko Yoshioka-Maeda

Organization

Tokyo Medical University

Division name

School of Nursing, Faculty of Medicine

Zip code


Address

6-1-1, Shinjuku, Shinjuku-ku,Tokyo 160-8402

TEL

0333516141

Email

kyoko@tokyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kyoko Yoshioka-Maeda

Organization

Tokyo Medical University

Division name

School of Nursing, Faculty of Medicine

Zip code


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 or person

Institute

School of Nursing, Faculty of Medicine, Tokyo Medical University

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

Japan


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


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://phn.s28.xrea.com/

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

Completed

Date of protocol fixation

2017 Year 03 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030289


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name