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
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
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
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
