UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030395 |
|---|---|
| Receipt number | R000034388 |
| Scientific Title | Development and a pilot trial of an internet-based educational program for reducing heavy drinking |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2021/06/16 17:00:16 |
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Basic information
Public title
Development and a pilot trial of an internet-based educational program for reducing heavy drinking
Acronym
Development and pilot trial of an ICT program for reducing heavy drinking
Scientific Title
Development and a pilot trial of an internet-based educational program for reducing heavy drinking
Scientific Title:Acronym
Development and pilot trial of an ICT program for reducing heavy drinking
Region
| Japan |
Condition
Condition
Alcohol use disorder
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and examine effectiveness of an internet-based personalized normative feedback intervention on alcohol-related problems
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alcohol consumption
Key secondary outcomes
AUDIT-C
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Personalized normative feedback
Interventions/Control_2
Psychoeducation on alcohol-related problems
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
AUDIT score of 8 or higher
Age between 20 and 65
Key exclusion criteria
AUDIT score of 7 or lower
Age lower than 20 and higher than 66
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Shimoyama |
Organization
Graduate School of Education, the University of Tokyo
Division name
Division of Clinical Psychology
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
81-3-5841-3949
h3954s@p.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Toshitaka |
| Middle name | |
| Last name | Hamamura |
Organization
Graduate School of Education, the University of Tokyo
Division name
Division of Clinical Psychology
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
81-3-5841-3904
Homepage URL
toshitaka.hamamura@gmail.com
Sponsor or person
Institute
Graduate School of Education, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Social ICT Global Creative Leader Program, the University of Tokyo
Grant-in-Aid for JSPS fellows (17J03078), Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Science Research Ethics and Safety
Address
7-3-1 Hongo Bunkyo-ku, Tokyo
Tel
81-3-5841-0643
lifescience.adm@gs.mail.u-tokyo.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
| 2017 | Year | 12 | Month | 25 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 14 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034388
