UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030298 |
|---|---|
| Receipt number | R000034147 |
| Scientific Title | Development components of the curriculum for nurses to develop essential knowledge and skill for beginners in genetics |
| Date of disclosure of the study information | 2017/12/07 |
| Last modified on | 2020/07/10 16:41:44 |
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Basic information
Public title
Development components of the curriculum for nurses to develop essential knowledge and skill for beginners in genetics
Acronym
Development components of the curriculum for nurses to develop essential knowledge and skill for beginners in genetics
Scientific Title
Development components of the curriculum for nurses to develop essential knowledge and skill for beginners in genetics
Scientific Title:Acronym
Development components of the curriculum for nurses to develop essential knowledge and skill for beginners in genetics
Region
| Japan |
Condition
Condition
congenital anomaly
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We try to make genetic educational program, the case of the baby and family who has chromosome abnormality, for premature nurses and students as a first step of the genetic continuous educational program.
Basic objectives2
Others
Basic objectives -Others
Exploratory intervention study using mixed methods
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate Participants' demographics,
experiences of education for genetic nursing
pre and post questionnnaire taking genetic nursing seminar
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
We make one continuous education program, chromosome abnomalitiy baby and family, for nurses who is beginar for genetic nursing throurh the framework which is made from previous studies. We will have 3 sessions for another group in Japan as a pilot study.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nursing professionals who are working in maternal and pediatric units less than 5 years
Or, Nursing professionals interested in genetic nursing
Or, Nursing students (either undergraduate or graduate students)
Key exclusion criteria
Certified genetic counselor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Murakami |
Organization
Yamaguchi University
Division name
Graduate School of Medicine
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
0836-22-2820
k.mura@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Murakami |
Organization
Yamaguchi University
Division name
Graduate School of Medicine
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
0836-22-2820
Homepage URL
k.mura@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Scientific Reserch KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board School of Health Sciences, Yamaguchi University
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
Tel
0836-22-2007
me202@yamaguchi-u.ac.jp
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
| 2017 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Nursing and Health Sciences
Number of participants that the trial has enrolled
42
Results
Results date posted
| 2020 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 11 | Month | 18 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2020 | 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 | 12 | Month | 07 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034147
