UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028118 |
|---|---|
| Receipt number | 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 02:25:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takahashi.r@tenriyorozu-u.ac.jp
Sponsor or person
Institute
Tenri Health Care University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032188
