UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046775 |
|---|---|
| Receipt number | R000053360 |
| Scientific Title | Development of a "Next Generation Medical Support System for Children" using ICT and medical, health, and lifestyle information |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/10/20 17:44:26 |
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Basic information
Public title
Development of a "Next Generation Medical Support System for Children" using ICT and medical, health, and lifestyle information
Acronym
ICT-Health Promotion
Scientific Title
Development of a "Next Generation Medical Support System for Children" using ICT and medical, health, and lifestyle information
Scientific Title:Acronym
ICT-Health Promotion
Region
| Japan |
Condition
Condition
Children with psychosomatic disorders
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate that children's implementation of a smartphone cognitive behavioral therapy application (Mugimaru) enables them to "gain a bird's eye view of their mental health" and "learn about resources for mental health support. We will prove that children in the Mugimaru group can maintain healthy mental health better than those in the non-Mugimaru group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of differences in the improvement of health scales between the application and non-application groups immediately after, 3 months after, and 6 months after the application.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
1. Electromagnetic informed consent/assent will be obtained for children aged 11-18 years who visit the principal or submitting institution for pediatric psychosomatic disorders (truancy, orthostatic adjustment disorder, eating disorder, sleep disorder, etc.), allergic disorders (food allergy, bronchial asthma, etc.), and endocrine disorders (short stature, obesity, etc.). Consent will be obtained using the abstract.
2. Random assignment of students to the application or non-application group.
3. Conduct child/parent face sheets and various psychological assessment evaluations from the tablet provided in the outpatient clinic (takes about 15 minutes). The entered data will be saved in the management server. The subject's management number when entered into the tablet will be managed in a corresponding table to protect personal information.
Subjects will install the cognitive-behavioral therapy application "Mugimaru 2" on their own smartphones using QR codes, and will implement the loaded program over a period of 2 to 4 weeks.
The evaluation items (QTA30, PHQ-9A) included in the application will be administered immediately after the application is completed. The primary and secondary endpoints will be entered in the tablet after 3 and 6 months of intervention.
Translated with www.DeepL.com/Translator (free version)
Interventions/Control_2
1. Consent will be obtained from junior and senior high school students at the model school using an electromagnetic informed consent/assent abstract.
2. Subjects implementing the application will install the cognitive behavioral therapy application "Mugimaru 2" on their own smartphones using a QR code. The program will be implemented over a period of 2 to 4 weeks. 3.
The assessment items (QTA30, PHQ-9A) included in the app will be administered immediately after completion of the app.
3.Translated with www.DeepL.com/Translator (free version)
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
| 11 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet the following conditions who visited the medical institution of the principal investigator and sub-researcher. Pediatric psychosomatic diseases (truancy, orthostatic dysregulation, eating disorder, sleep disorder, etc.) Allergic diseases (food allergy, bronchial asthma, etc). Endocrine disorders (short stature, obesity, etc.)
Target group II: Students attending model junior high and high schools in Fukuoka City. Target age: 13-18 years old (junior high school and high school students)
Key exclusion criteria
At the time of entry and at the time of checkpoint, the subjects checked more than half of the time in two weeks or almost every day in question item 9 of PHQ-9A of the depression screening scale, "How often have you felt like dying in the past two weeks? Subjects who checked more than half of the questions in the past two weeks and almost every day at the checkpoint. Those who cannot answer the questionnaire. Those who do not own a smart phon
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nagamitsu |
Organization
Fukuoka University
Division name
Department of Pediatrics
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-Ku, 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
Department of Pediatrics
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka city
TEL
0928011011
Homepage URL
snagamit@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
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
Address
7-45-1 Nanakuma, Jonan-Ku, Fukuoka city
Tel
0928011011
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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
115
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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 01 | Month | 29 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053360
