UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018186
Receipt number R000020982
Scientific Title Feasibility and efficacy of peer education for children with asthma : a pilot study
Date of disclosure of the study information 2015/07/03
Last modified on 2016/07/03 09:17:01

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Basic information

Public title

Feasibility and efficacy of peer education for children with asthma : a pilot study

Acronym

Peer education for children with asthma : a pilot study

Scientific Title

Feasibility and efficacy of peer education for children with asthma : a pilot study

Scientific Title:Acronym

Peer education for children with asthma : a pilot study

Region

Japan


Condition

Condition

Asthma

Classification by specialty

Clinical immunology Pediatrics Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Feasibility

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To assess the feasibility of asthma education program with peer education.

Key secondary outcomes

To assess the efficacy of asthma education program with peer education.
1 asthma control (JPAC)
2 Adherence
3 level of asthma knowledge


Base

Study type


Study design

Basic design

Single arm

Randomization

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

Other

Interventions/Control_1

Asthma education program with peer education and patient education program using a touch-screen computer

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

9 years-old <=

Age-upper limit

12 years-old >=

Gender

Male and Female

Key inclusion criteria

Asthma patients who visit the pediatric allergy outpatient care clinic at the National Center for Child Health and Development

Key exclusion criteria

1.Children disagree for participating in the study.

2.Caregivers disagree for their children participating in the study.

3.Researchers judge the study is not suitable for children.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukihiro Ohya

Organization

National Center for Child Health and Development

Division name

Division of Allergy

Zip code


Address

2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan

TEL

03-3416-0181

Email

ohya-y@ncchd.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohisa Ando

Organization

National Center for Child Health and Development

Division name

Division of Allergy

Zip code


Address

2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan

TEL

03-3416-0181

Homepage URL


Email

ando-tm@ncchd.go.jp


Sponsor or person

Institute

National Center for Child Health and Development

Institute

Department

Personal name



Funding Source

Organization

Environmental Restoration and Conservation Agency Grant

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 03 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2015 Year 06 Month 25 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 03 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

2015 Year 07 Month 03 Day

Last modified on

2016 Year 07 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020982


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name