UMIN-CTR Clinical Trial

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
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014966