UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021348 |
|---|---|
| Receipt number | R000024616 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2018/04/06 16:34:43 |
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Basic information
Public title
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
Acronym
Evaluation of the effectiveness of the End-of-Life Nursing Education Consortium-Japan Critical Care Curriculum Faculty Development Program.
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Nin Kazuko |
Organization
Kyoto University Graduate School of Medicine
Division name
School Human Health Science
Zip code
Address
53 Shogoin Kawahara-cho,sakyo-ku,Kyoto,606-8507,Japan
TEL
075-751-3946
nin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Tamura |
Organization
Kyoto University Graduate School of Medicine
Division name
School Human Health Science
Zip code
Address
53 Shogoin Kawahara-cho,sakyo-ku,Kyoto,606-8507,Japan
TEL
075-311-5544
Homepage URL
tamura.yoko.62e@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
| 2016 | Year | 03 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024616
