UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032816
Receipt number 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 17:44:44

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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 or person

Institute

dep. of pediatrics, Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name



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

Value
https://center6.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