UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042517 |
|---|---|
| Receipt number | 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 17:56:40 |
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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
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
kaoru@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics & Child Health, Kurume University school of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048534
| 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 |
