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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032687
Receipt No. R000037278
Scientific Title Developmental of a nurse training program for inproving a skill of assist in ordinary medical care for children with developmental deisabilities 2 - Evaluation of "case study" proguram
Date of disclosure of the study information 2018/05/27
Last modified on 2019/05/24

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Basic information
Public title Developmental of a nurse training program for inproving a skill of assist in ordinary medical care for children with developmental deisabilities 2 - Evaluation of "case study" proguram
Acronym Developmental of a nurse training program for inproving a skill of assist in ordinary medical care for children with developmental deisabilities 2
Scientific Title Developmental of a nurse training program for inproving a skill of assist in ordinary medical care for children with developmental deisabilities 2 - Evaluation of "case study" proguram
Scientific Title:Acronym Developmental of a nurse training program for inproving a skill of assist in ordinary medical care for children with developmental deisabilities 2
Region
Japan

Condition
Condition nurse
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Develop a training program (case study) for nurses in clinical departments where children visit on a daily basis and verify their effectiveness
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) knowledge of nursing for children with developmental disorders
2) aggressiveness of responding to children with developmental disabilities and their parents
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
Behavior,custom
Interventions/Control_1 The nurse takes "a case study meeting which knows concrete correspondence of children with developmental disabilities"
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pediatrics, in otolaryngology, ophthalmology, dermatology nurse who works in the clinic, those who consent was obtained for cooperation in this investigation based on the free will of the person.
Key exclusion criteria I don't have any exclusion criteria.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name rika
Middle name
Last name tsubomi
Organization Hamamatsu University School of Medicine
Division name Faculty of Nursing
Zip code 431-3192
Address 1-20-1,Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL 053-435-2824
Email rikachtb@hama-med.ac.jp

Public contact
Name of contact person
1st name rika
Middle name
Last name Tsubomi
Organization Hamamatsu University School of Medicine
Division name Faculty of Nursing
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL 053-435-2807
Homepage URL
Email rikachtb@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Hamamatsu University School of Medicine
Address 1-20-1,Handayama, Higashi-ku, Hamamatsu city, Shizuoka
Tel 053-435-2824
Email rikachtb@hama-med.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
2018 Year 05 Month 27 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 27 Day
Date of IRB
2017 Year 09 Month 14 Day
Anticipated trial start date
2018 Year 05 Month 27 Day
Last follow-up date
2021 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
2018 Year 05 Month 23 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037278

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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