UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053063 |
|---|---|
| Receipt number | R000060528 |
| Scientific Title | Development of Nursing Support Methods Focused on Self-Care for School-Age Children with Atopic Dermatitis |
| Date of disclosure of the study information | 2023/12/11 |
| Last modified on | 2023/12/11 18:43:42 |
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Basic information
Public title
Development of Nursing Support Methods Focused on Self-Care for School-Age Children with Atopic Dermatitis
Acronym
Development of Nursing Support Methods Focused on Self-Care for School-Age Children with Atopic Dermatitis
Scientific Title
Development of Nursing Support Methods Focused on Self-Care for School-Age Children with Atopic Dermatitis
Scientific Title:Acronym
Development of Nursing Support Methods Focused on Self-Care for School-Age Children with Atopic Dermatitis
Region
| Japan |
Condition
Condition
Atopic Dermatitis
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Focusing on self-care for school-age children with atopic dermatitis (AD), this nursing support method aims to elucidate its impact on maintaining and improving children's self-care, alleviating AD symptoms, and influencing the mental health and quality of life (QOL) of both the child and the caregiver.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome measure is the child's self-care. It will be assessed before the intervention, and at 3, 6, and 12 months post-intervention.
Key secondary outcomes
The secondary outcome measures include skin condition, sleep status, quality of life (QOL), depression, and self-efficacy. These will be evaluated before the intervention, and at 3, 6, and 12 months post-intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Interventions will be conducted by ten pediatric allergy educators using a self-care checklist. Implementation will occur once a month, with each session lasting approximately 15 to 30 minutes.
Interventions/Control_2
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Being diagnosed with atopic dermatitis and providing consent to participate in the study.
Key exclusion criteria
Non.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Yugeta |
Organization
Tokyo Ariake University of Medical Sciences
Division name
Nursing Department, Faculty of Nursing
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo, Japan
TEL
03-6703-7000
yugetam@tau.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Yugeta |
Organization
Tokyo Ariake University of Medical Sciences
Division name
Nursing Department, Faculty of Nursing
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo, Japan
TEL
03-6703-7000
Homepage URL
yugetam@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical Sciences, Nursing Department, Faculty of Nursing,Mika Yugeta
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health Siences University of Hokkaido
Address
1757 Kanazawa, Tobetsu-cho, Hokkaido
Tel
0133-23-1211
myugeta@hoku-iryo-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | 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 | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060528
| 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 |
