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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042517
Receipt No. R000048534
Scientific Title Adolescent health promotion through health supervision and mobile technology (2)
Date of disclosure of the study information 2020/11/21
Last modified on 2020/11/21

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Basic information
Public title Adolescent health promotion through health supervision and mobile technology (2)
Acronym Adolescent health supervision / CBT application (2)
Scientific Title Adolescent health promotion through health supervision and mobile technology (2)
Scientific Title:Acronym Adolescent health supervision / CBT application (2)
Region
Japan

Condition
Condition Children with chronic disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Promotion for adolescent with chronic disease health by health supervision and CBT application
Basic objectives2 Others
Basic objectives -Others Stress coping with help seeking behavior and self-monitoring
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To promote adolescent health for children with chronic disease
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 Adolescent Health Supervision group
Interventions/Control_2 Adolescent Health Supervision and Cognitive Behavioral Therapy group
Interventions/Control_3 Non interventional group
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
13 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria 1. Children showing consent to attend this project
2. Children's caregivers showing consent to attend this project
3. Children's age: ranged from 13 to 18
4. Having a smartphone
Key exclusion criteria 1. Children having depressive symptoms
2. Children being suspected as depression or suicidal ideation by psychometric profiles
3. Children who were judged as inappropriate subjects by researcher
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shinichiro
Middle name
Last name Nagamitsu
Organization Kurume University School of Medicine
Division name Department of Pediatrics & Child Health
Zip code 8300011
Address 67 Asahi-machi Kurume city
TEL 0942353311
Email kaoru@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name Shinichiro
Middle name
Last name Nagamitsu
Organization Kurume University School of Medicine
Division name Department of Pediatrics & Child Health
Zip code 830-0011
Address 67 Asahi-machi Kurume city
TEL 0942353311
Homepage URL http://www.amed-teen.com
Email kaoru@med.kurume-u.ac.jp

Sponsor
Institute Department of Pediatrics & Child Health, Kurume University school of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Kurume University Hospital Clinical Trial Center
Address 67 Asahi machi Kurume city
Tel 0942317201
Email rinsyou-cen@kurume-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
2020 Year 11 Month 21 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
2020 Year 08 Month 27 Day
Date of IRB
2020 Year 08 Month 27 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2021 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
2020 Year 11 Month 21 Day
Last modified on
2020 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048534

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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