UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027658 |
|---|---|
| Receipt number | R000031684 |
| Scientific Title | Effects of a group alcohol intervention for evacuees after the Great East Japan Earthquake |
| Date of disclosure of the study information | 2017/06/06 |
| Last modified on | 2017/08/07 09:37:45 |
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Basic information
Public title
Effects of a group alcohol intervention
for evacuees after the Great East Japan
Earthquake
Acronym
Alcohol Intervention
Scientific Title
Effects of a group alcohol intervention
for evacuees after the Great East Japan
Earthquake
Scientific Title:Acronym
Alcohol Intervention
Region
| Japan |
Condition
Condition
The evacuees who might have risk of
alcohol abuse
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is to identify the risk factor of alcohol use disorders among evacuees
after the Great East Japan Earthquake,
and develop a group alcohol intervention
program.
Basic objectives2
Others
Basic objectives -Others
This presents two studies. The first
study aims to develop a questionnaire to
identify change in alcohol consumption
factors among the evacuees after the Great East Japan Earthquake. In the second study, we developed a group alcohol intervention program based on the Hizen Alcoholism Program by Yuzuriha (HAPPY) to investigate how the intervention could be effective for the evacuees who might have risk of
alcohol abuse
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a. Participants' sociodemographic information and disaster-related situations
b. Burn-out Inventory
c. PHQ-9
d. AUDIT
e. Participants' drinking behavior
f. SOCRATES
g. Alcohol class evaluation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Alchol consumption between pre-post
alcohol class
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Only those that informed consent was
obtained
Key exclusion criteria
None
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maeda, Masaharu |
Organization
Fukushima Medical University
Division name
Department of Disaster Psychiatry
Zip code
Address
Hikarigaoka 1 Fukushima-city, Fukushima
TEL
024-547-1887
masagen@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ueda, Yuka |
Organization
Fukushima Medical University
Division name
Department of Epidemiology
Zip code
Address
Hikarigaoka 1 Fukushima-city, Fukushima
TEL
024-547-1343
Homepage URL
yukaueda@hotmail.com
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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 | 06 | Month | 06 | 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
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2017 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031684
