UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032687
Receipt number 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 2022/08/17 09:17:10

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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 or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



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

Completed

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

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 05 Month 23 Day

Last modified on

2022 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037278