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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000030298
Receipt No. 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

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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
Email 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
Email k.mura@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034147

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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