UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052705 |
|---|---|
| Receipt number | R000059974 |
| Scientific Title | Empirical study on children's health promotion with CBT application using GIGA School |
| Date of disclosure of the study information | 2023/11/06 |
| Last modified on | 2024/02/02 08:14:35 |
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Basic information
Public title
Empirical study on children's health promotion with CBT application using GIGA School
Acronym
Empirical study on children's health promotion with CBT application using GIGA School
Scientific Title
Empirical study on children's health promotion with CBT application using GIGA School
Scientific Title:Acronym
Empirical study on children's health promotion with CBT application using GIGA School
Region
| Japan |
Condition
Condition
healthy children
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Self-monitoring application (Mugimaru) will be installed in GIGA School (tablet devices for students) in schools, and it will be revealed that the health of students who implement the application will improve (health promotion).
Basic objectives2
Others
Basic objectives -Others
Correlation detection between app-input text data and baseline psychological measures
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in QTA30 scores before and after implementation of the app
Key secondary outcomes
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
| Other |
Interventions/Control_1
Implementation of mental health application
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
| 10 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students enrolled in elementary, junior high and high schools
Key exclusion criteria
Persons who are unable to complete the questionnaire
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nagamitsu |
Organization
Fukuoka University
Division name
Pediatrics
Zip code
8140180
Address
7-45-1 Nanakuma Jounanku Fukuoka city
TEL
0928011011
snagamit@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nagamitsu |
Organization
Fukuoka University
Division name
Pediatrics
Zip code
8140180
Address
7-45-1 Nanakuma Jounanku Fukuoka city
TEL
09052881197
Homepage URL
snagamit@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University ethitic committe
Address
7-45-1 Nanakuma Jounanku Fukuoka city
Tel
09052881197
snagamit@fukuoka-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 | 11 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 08 | 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 | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059974
