UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012867
Receipt number R000014966
Scientific Title The Effect of Patient Education in Initial Treatment of Children with Atopic Dermatitis by Pediatric Allergy Educator
Date of disclosure of the study information 2014/01/20
Last modified on 2021/02/01 16:02:05

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Basic information

Public title

The Effect of Patient Education in Initial Treatment of Children with Atopic Dermatitis by Pediatric Allergy Educator

Acronym

The Effect of Patient Education for Chilren with Atopic Dermatitis by Pediatric Allergy Educator

Scientific Title

The Effect of Patient Education in Initial Treatment of Children with Atopic Dermatitis by Pediatric Allergy Educator

Scientific Title:Acronym

The Effect of Patient Education for Chilren with Atopic Dermatitis by Pediatric Allergy Educator

Region

Japan


Condition

Condition

Children with Atopic Dermatitis

Classification by specialty

Clinical immunology Pediatrics Dermatology
Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To test whether pediatric allergy educator leads the effectiveness of patient education at the stage of initial treatment for pediatric patients with atopic dermatitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

SCORAD, at baseline, 10 weeks later

Key secondary outcomes

DFI(Family impact of childhood eczema questionnaire)
QPCAD(Quality of Life in Primary Caregivers if children with Atopic Dermatitis)
The number of Skin care
Amout of steroid,tacrolimus
ointment and moisturizer usage at baseline, 2 weeks, 6 weeks, 10 weeks later


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration

Institution is considered as a block.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

Standard Therapy and Patient education by pediatric allergy educator.

Interventions/Control_2

Standard Therapy and Patient education by pediatrician or/and allergist.

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

1 years-old <=

Age-upper limit

10 years-old >

Gender

Male and Female

Key inclusion criteria

1)Moderate or sever eczema according to Guidelines for Management of Atopic Dermatitis 2012.
2)To be treated as an outpatient at the research facility.
3)The primary caregiver is the patients,and either one of the parents can visit to the outpatient.

Key exclusion criteria

1)Need emergency admission.
2)Can not practice Proactive Therapy.
3)In-charge doctor judges.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Akasawa

Organization

Tokyo Metropolitan Children's Medical Center

Division name

Department of Allergy

Zip code


Address

2-8-29,Musashidai,Fuchu,Tokyo,Japan

TEL

042-300-5111

Email

akira_akasawa@tmhp.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ikuyo Masuko

Organization

Tokyo Metropolitan Children's Medical Center

Division name

Department of Allergy

Zip code


Address

2-8-29,Musashidai,Fuchu,Tokyo,Japan

TEL

042-300-5111

Homepage URL


Email

masuko.ik@gmail.com


Sponsor or person

Institute

Tokyo Metropolitan Children's Medical Center

Institute

Department

Personal name



Funding Source

Organization

Environmental Restoration and Conservation Agency

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Fukuoka National Hospital

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

東京都立小児総合医療センター(東京都)、国立病院機構福岡病院(福岡県)


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 20 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

Open public recruiting

Date of protocol fixation

2013 Year 12 Month 01 Day

Date of IRB

2012 Year 12 Month 19 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2018 Year 09 Month 30 Day

Date of closure to data entry

2018 Year 11 Month 15 Day

Date trial data considered complete

2019 Year 02 Month 10 Day

Date analysis concluded

2020 Year 05 Month 15 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 16 Day

Last modified on

2021 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014966


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name