UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050526 |
|---|---|
| Receipt number | R000057538 |
| Scientific Title | A randomized controlled trial of a smartphone application for reducing smartphone usage time (Smart Use) for Japanese potential members of smartphone addiction |
| Date of disclosure of the study information | 2023/03/07 |
| Last modified on | 2023/03/07 17:09:13 |
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Basic information
Public title
A randomized controlled trial of a smartphone application for reducing smartphone usage time (Smart Use) for Japanese potential members of smartphone addiction
Acronym
A randomized controlled trial of a smartphone application for reducing smartphone usage time (Smart Use) for Japanese potential members of smartphone addiction
Scientific Title
A randomized controlled trial of a smartphone application for reducing smartphone usage time (Smart Use) for Japanese potential members of smartphone addiction
Scientific Title:Acronym
A randomized controlled trial of a smartphone application for reducing smartphone usage time (Smart Use) for Japanese potential members of smartphone addiction
Region
| Japan |
Condition
Condition
potential members of smartphone addiction
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the effectiveness of smartphone application (Smart Use) for reducing smartphone usage time among children users in parent-child users who is potential members of smartphone addiction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Smartphone usage time
Key secondary outcomes
Smartphone addiction scale short version in Japanese (SAS-SV-J)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use a smartphone application (Smart Use)
Interventions/Control_2
Assessment only
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
| 12 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Junior high and high school students who use smartphones on a daily basis, and their parents.
- Those who use smartphones for at least one hour a day.
- Parents give allowance to their children every month.
- Those who have been using the current model for more than one month and do not plan to change the model within the next month.
- Gives full informed consent to participate in the study
Key exclusion criteria
- Those who do routinely use a smartphone installed with android
- Those who has been judged to be not suitable for the subject of this this study by the principal investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhito |
| Middle name | |
| Last name | Hasegawa |
Organization
University of Fukui
Division name
School of Engineering
Zip code
910-8507
Address
3-9-1, Bunkyo, Fukui, Fukui, Japan
TEL
+81-776-27-8929
t-hase@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuhito |
| Middle name | |
| Last name | Hasegawa |
Organization
University of Fukui
Division name
School of Engineering
Zip code
910-8507
Address
3-9-1, Bunkyo, Fukui, Fukui, Japan
TEL
+81-776-27-8929
Homepage URL
t-hase@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Foundation for the Fusion Of Science and Technology
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
University of Fukui
Address
3-9-1, Bunkyo, Fukui, Fukui, Japan
Tel
+81-776-27-8929
t-hase@u-fukui.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 | 03 | Month | 07 | 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
106
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
Main results already published
Date of protocol fixation
| 2021 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2022 | 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
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057538
