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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032816
Receipt No. R000031134
Scientific Title clinical study on nursing care at school for children with special health care need
Date of disclosure of the study information 2018/05/31
Last modified on 2018/05/31

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Basic information
Public title clinical study on nursing care at school for children with special health care need
Acronym study on nursing care at school
Scientific Title clinical study on nursing care at school for children with special health care need
Scientific Title:Acronym study on nursing care at school
Region
Japan

Condition
Condition children dependent on ventilator
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to assess merits/demerits on nursing care provided by visiting nurse at school for children dependent on ventilator
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes narrative description of feasibility, problems, and merits/demerits of 3 patterns of nursing care for children dependent on ventilator at school provided by visiting nurse ,with the end in March, 2018
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 A visiting nurse provides nursing care of the child during stay at school. Intervention is performed for 2 weeks, 4 hours a day.
Interventions/Control_2 A visiting nurse instructs to school nurses on nursing care of the targeted child. Nursing care is provided by school nurses. Intervention is performed for 2 weeks, 4 hours a day.
Interventions/Control_3 During a busy time a visiting nurse provides nursing care of the child, and in other time she instructs to school nurses on his/her nursing care. Nursing care is provided by both nurses. Intervention is performed for 2 weeks, 4 hours a day.
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
6 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria school children dependent on ventilator, with intention to go to school
Key exclusion criteria having tendency to get severely ill by going to school
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Tamura
Organization Saitama Medical Center, Saitama Medical University
Division name dep. of pediatrics
Zip code
Address 1981, Kamoda, Kawagoe City, Saitama Pref., Japan
TEL 049-228-3714
Email mstamura@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiai Nagura
Organization Saitama Medical Center, Saitama Medical University
Division name dep. of pediatrics
Zip code
Address 1981, Kamoda, Kawagoe City, Saitama Pref., Japan
TEL 049-228-3616
Homepage URL
Email akinag@saitama-med.ac.jp

Sponsor
Institute dep. of pediatrics, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Ministry of Health,Labor, and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 埼玉県立川島ひばりが丘特別支援学校他

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 31 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
2017 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 12 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
2018 Year 05 Month 31 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031134

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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