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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036244
Receipt No. R000041282
Scientific Title A randomized controlled trial to evaluate an effect of brief intervention for problem drinking
Date of disclosure of the study information 2019/05/01
Last modified on 2019/03/18

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Basic information
Public title A randomized controlled trial to evaluate an effect of brief intervention for problem drinking
Acronym A study on an effect evaluation of brief intervention for problem drinking
Scientific Title A randomized controlled trial to evaluate an effect of brief intervention for problem drinking
Scientific Title:Acronym A RCT of effect evaluation of brief intervention for problem drinking
Region
Japan

Condition
Condition problem drinking
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate an effect of the brief intervention for problem drinker
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Quantity of alcohol consumption, frequency of alcohol drinking, frequency of the binge drinking
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 4
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Oral instruction (15 minutes)
Interventions/Control_2 Oral instruction (5 minutes)
Interventions/Control_3 Delivery of a brochure
Interventions/Control_4 Oral instrcution by using positive words
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
74 years-old >=
Gender Male and Female
Key inclusion criteria Person with AUDIT score 8 points or more
Key exclusion criteria Patients with alcohol dependence, pregnant woman
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Yoneatsu
Middle name
Last name Osaki
Organization Tottori University, Faculty of Medicine
Division name Division of environmental and preventive medicine
Zip code 6838503
Address Nishi-cho 86, Yonago, Tottori, Japan
TEL +81859386103
Email yoneatsu@tottori-u.ac.jp

Public contact
Name of contact person
1st name Yoneatsu
Middle name
Last name Osaki
Organization Tottori University, Faculty of Medicine
Division name Division of environmental and preventive medicine
Zip code 683-8503
Address Nishi-cho 86, Yonago, Tottori
TEL +81859386103
Homepage URL
Email yoneatsu@tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization 11070

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tottori University, Faculty of Medicine
Address Nishi-cho 86
Tel +81859386103
Email yoneatsu@tottori-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
2019 Year 05 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 05 Day
Date of IRB
2018 Year 07 Month 12 Day
Anticipated trial start date
2018 Year 12 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
2019 Year 03 Month 18 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041282

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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