UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050888 |
|---|---|
| Receipt number | R000057998 |
| Scientific Title | Research on pathophysiological education for children with food allergies in early school age. |
| Date of disclosure of the study information | 2023/04/19 |
| Last modified on | 2023/10/25 10:10:40 |
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Basic information
Public title
Research on pathophysiological education for children with food allergies in early school age.
Acronym
Research on pathophysiological education for children with food allergies in early school age.
Scientific Title
Research on pathophysiological education for children with food allergies in early school age.
Scientific Title:Acronym
Research on pathophysiological education for children with food allergies in early school age.
Region
| Japan |
Condition
Condition
Food Allergy
Classification by specialty
| Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of education on the pathophysiology of food allergies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of understanding of knowledge about pathophysiology,
Relationship between understanding of pathophysiological knowledge and children's QOL.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
15 minutes individual education using pamphlets
Interventions/Control_2
Distribution of pamphlets
Interventions/Control_3
Establish a control group.
Without intervention
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
| 6 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Early school age children (1st to 3rd grade elementary school) and their families undergoing an oral food challenge test.
2) Those who can answer questionnaires in Japanese.
Key exclusion criteria
1) Those who undergo tests for the purpose of definitive diagnosis of causative foods.
2) Patients with intellectual disabilities.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Hasegawa |
Organization
University of Toyama
Division name
Department of Maternity Nursing, Faculty of Medicine
Zip code
930-0914
Address
2630 Sugitani, Toyama
TEL
076-434-7430
thase@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Matsumoto |
Organization
University of Toyama
Division name
Graduate of Medicine and Pharmaceutical Sciences, Department of Nursing Sciences
Zip code
930-0914
Address
2630 Sugitani, Toyama
TEL
076-434-5410(765)
Homepage URL
d1862403@ems.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
2630 Sugitani, Toyama
Tel
076-415-8857
rinri@adm.u-toyama.ac.jp
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
富山市富山市民病院（富山県）
むらかみ小児科アレルギークリニック(富山県）
富山赤十字病院（富山県）
厚生連高岡病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 19 | 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
| 2023 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057998
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
