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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012867
Receipt No. 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 2018/10/25

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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
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
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
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 16 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.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


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