UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032556 |
|---|---|
| Receipt number | R000037133 |
| Scientific Title | Effectiveness of Alcohol Screening and Brief Intervention (SBI) on the working generation in a rural island of Kagoshima |
| Date of disclosure of the study information | 2018/05/11 |
| Last modified on | 2019/06/19 11:22:44 |
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Basic information
Public title
Effectiveness of Alcohol Screening and Brief Intervention (SBI) on the working generation in a rural island of Kagoshima
Acronym
Effectiveness of Alcohol SBI in a rural island
Scientific Title
Effectiveness of Alcohol Screening and Brief Intervention (SBI) on the working generation in a rural island of Kagoshima
Scientific Title:Acronym
Effectiveness of Alcohol SBI in a rural island
Region
| Japan |
Condition
Condition
Excessive alcohol drinkers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To examine the effectiveness of Alcohol SBI on municipal workers and the general population in Yoron Town.
2. To identify factors associating with the successful reduction of alcohol intake of participants of SBI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Alcohol Use Disorders Identification Test (AUDIT).
Difference in the average score between pre- (the baseline) and post- (two months after, three months after, and five months after) the first session of SBI.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Lecture session (1 session): disseminate basic knowledge of alcohol on human health, current alcohol intake status of local residents, and process of SBI
Brief Intervention (2 sessions): consists of group-working and drinking diary sessions. The first session is about 30 minutes long, and the second is 10 minutes.
Interventions/Control_2
Waiting group. After completing the SBI on the first intervention group, the same SBI will be implemented for the second group.
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Employees of Yoron municipal government with his/her AUDIT score 8 and over,. on AUDIT,want to participate in Brief Intervention program, and understand the purpose of the research
Key exclusion criteria
Person who has been diagnosed as alcohol dependent or has experiment of treatment for over drinking.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Akiyama |
Organization
Keio University
Division name
Graduate School of Health Management
Zip code
2520883
Address
4411 Endo, Fujisawa, Kanagawa
TEL
0466-49-6265
miki@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Sakurai |
Organization
Keio University
Division name
Graduate School of Health Management
Zip code
2520083
Address
4411 Endo, Fujisawa, Kanagawa
TEL
0466-49-6265
Homepage URL
h17120js@sfc.keio.ac.jp
Sponsor or person
Institute
Graduate School of Health Management, Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Graduate School of Health Management, Keio University
Address
4411 Endo, Fujisawa, Kanagawa 252-0883
Tel
0466-49-6265
gshm-rinri@adst.keio.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
| 2018 | Year | 05 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 11 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037133
