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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028118
Receipt No. R000032188
Scientific Title Effectiveness of Community Based Alcohol Brief Interventions for High-Risk Drinkers in a Rural Community, Western Kenya
Date of disclosure of the study information 2017/07/07
Last modified on 2017/07/07

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Basic information
Public title Effectiveness of Community Based Alcohol Brief Interventions for High-Risk Drinkers in a Rural Community, Western Kenya
Acronym Community-based alcohol brief intervention for high-risk drinkers in Kenya
Scientific Title Effectiveness of Community Based Alcohol Brief Interventions for High-Risk Drinkers in a Rural Community, Western Kenya
Scientific Title:Acronym Community-based alcohol brief intervention for high-risk drinkers in Kenya
Region
Africa

Condition
Condition Healthy adults:high-risk drinkers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness of community-based ABI delivered by Community health worker with or without motivational talk by former drinker in reducing AUDIT
Basic objectives2 Others
Basic objectives -Others Effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Score of the Alcohol Use Disorders Identification Test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 3 times brief counseling
Interventions/Control_2 3 times brief counseling plus 2 timess motivational talk
Interventions/Control_3 Provided general information related on alcohol take
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1)Male and female aged 18 to 65
2)Individuals with an AUDIT score of 8 to 19
3)Individuals with permanent residence in the study area and with no plan of moving out in the next 12 months
4)Individuals who are willing to participate in the study
Key exclusion criteria 1)Pregnant women
2)Individuals with history of alcohol related health problems or psychiatric disease
3)Individuals who are currently under treatment for alcohol related health problems or a psychiatric disease
4)Individuals participating or intending to participate in another alcohol related intervention
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name RISA TAKAHASHI
Organization Tenri Health Care University
Division name Department of Nursing sciences
Zip code
Address 80-1 Bessho-cho, Tenri, Nara
TEL 81-743-63-7811
Email takahashi.r@tenriyorozu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name RISA TAKAHASHI
Organization Tenri Health Care University
Division name Department of Nursing sciences
Zip code
Address 80-1 Bessho-cho, Tenri, Nara
TEL 81-743-63-7811
Homepage URL
Email takahashi.r@tenriyorozu-u.ac.jp

Sponsor
Institute Tenri Health Care University
Institute
Department

Funding Source
Organization MEXT JAPAN
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
Address
Tel
Email

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 07 Month 07 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
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2017 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032188

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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