UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009400 |
|---|---|
| Receipt number | R000011044 |
| Scientific Title | The effects of palliative care and end-of-life care education program for nurses : randomized control trial using wait list control |
| Date of disclosure of the study information | 2012/11/27 |
| Last modified on | 2014/09/20 23:22:56 |
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Basic information
Public title
The effects of palliative care and end-of-life care education program for nurses : randomized control trial using wait list control
Acronym
The effects of palliative care and end-of-life care education program for nurses: RCT using wait list control
Scientific Title
The effects of palliative care and end-of-life care education program for nurses : randomized control trial using wait list control
Scientific Title:Acronym
The effects of palliative care and end-of-life care education program for nurses: RCT using wait list control
Region
| Japan |
Condition
Condition
Palliative care
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the effects of palliative care and end-of-life care education program for nurses: ELNEC-J (End-of Life Nursing Education Consortium -Japan) core curriculum nursing education program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Knowledge toward palliative care and end-of-life care before the intervention, 1 weeks after the intervention, at 2 months, at 6 months
Key secondary outcomes
Attitude toward palliative care and end-of-life care
Satisfaction of the training
Difficulty of the training
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
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
| Behavior,custom | Maneuver |
Interventions/Control_1
Nurses of intervention group take ELNEC-J core curriculum nursing education program for 2 days.
Interventions/Control_2
After 2 months, Nurses of control group take the same program for 2 days.
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
This study will be carried out in 2 regions; Miyagi and Osaka in Japan.
Nurses who worked the hospitals in 2 regions mentioned above.
Nurses who have clinical experiences over 3 years and the experiences providing care for cancer patients
Nurses who can attend the 2 days program
Nurses who permit participation in this study
Key exclusion criteria
Nurses who had ever taken ELNEC-J core curriculum nursing education program
Nurses who had completed ELNEC-J faculty development program
Target sample size
188
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsunori Miyashita |
Organization
Tohoku University School of Medicine
Division name
Department of Palliative Nursing, Health Science
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Mayagi, Japan
TEL
022-717-7924
miya@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Arahata |
Organization
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Nursing science
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, Japan
TEL
044-567-1576
Homepage URL
ara-tomo@md.tsukuba.ac.jp
Sponsor or person
Institute
Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
東北大学大学院医学系研究科（宮城県）
淀川キリスト教病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2014 | 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
| 2012 | Year | 11 | Month | 27 | Day |
Last modified on
| 2014 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011044
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
