UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effectiveness of the End-of-Life Nursing Education Consortium-Japan Critical Care Curriculum Faculty Development Program for critical care nurses: A Randomized controlled trial
Title of the study (Brief title)	Evaluation of the effectiveness of the End-of-Life Nursing Education Consortium-Japan Critical Care Curriculum Faculty Development Program.
Region	Japan

Condition
Condition	Nurse/Faculty of nursing
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the effectiveness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Confidence
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Education
Interventions/Control_2	period of intervention:half year number of times:three
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	1.Nurses who work at the clinical settings and meet criteria such as; a)They had more than clinical experience five years,and is more than a leader of post class b)They had experience that practiced a critical care nursing and the end of life care for nurses more than ten hours c)They had own facilities and a will to carry out the end of life care using the ELNEC-J critical care curriculum and the education of the critical care nursing in an area,and can get a consent,recommendation book of the facilities head or the senior nursing officer d)The nurse who agree to answer the questionnaire survey 3 months and 6 months later before program attendance e)The nurse who agree to the registration to a database(information listed in a participation application)as ELNEC-J critical care curriculum faculty f)The person who can secure either schedule of 24.25 September 2016 or 4.5 March 2017. 2.Faculty of nursing who work at the university/college of nursing meet criteria such as; a)They engaged in end of life care and the education of the critical care nursing in educational institutions such as the college of nursing/University b)They had the experience that practiced a critical care nursing and the end of life care for nursing students or nurses more than ten hours c)They had own facilities and a will to carry out the end of life care using the ELNEC-J critical care curriculum and the education of the critical care nursing in an area, and can get a consent, recommendation book of the facilities head or the senior nursing officer d)They can agree to cooperation to questionnaire survey 3 months and 6 months later before program attendance e)They can agree to the registration to a database(information listed in a participation application)as ELNEC-J critical care curriculum faculty
Key exclusion criteria	The person who had attended the ELNEC-Japan Core training program or the ELNEC-Japan Core Curriculum train-the-trainer program before.
Target sample size	82

Research contact person
Name of lead principal investigator	Nin Kazuko
Organization	Kyoto University Graduate School of Medicine
Division name	School Human Health Science
Address	53 Shogoin Kawahara-cho,sakyo-ku,Kyoto,606-8507,Japan
TEL	075-751-3946
Email	nin@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yoko Tamura
Organization	Kyoto University Graduate School of Medicine
Division name	School Human Health Science
Address	53 Shogoin Kawahara-cho,sakyo-ku,Kyoto,606-8507,Japan
TEL	075-311-5544
Homepage URL
Email	tamura.yoko.62e@st.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 02 Day
Anticipated trial start date	2016 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 04 Day
Last modified on	2018 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024616