UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036408 |
|---|---|
| Receipt number | R000041142 |
| Scientific Title | A pilot randomized controlled trial of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers |
| Date of disclosure of the study information | 2019/04/09 |
| Last modified on | 2022/02/16 14:31:36 |
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Basic information
Public title
A pilot randomized controlled trial of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Acronym
A pilot randomized controlled trial of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Scientific Title
A pilot randomized controlled trial of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Scientific Title:Acronym
A pilot randomized controlled trial of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Region
| Japan |
Condition
Condition
Heavy drinkers
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the amount of alcohol consumption in the past 1 week measured with the TLFB method from pre- to post treatment(after 8 week, 12 week)
Key secondary outcomes
Change in AUDIT total score from pre- to post treatment (after 12 week)
Presence / absence of wish to reduce drinking amount, experience receiving guidance to reduce drinking amount, self-confidence to save alcohol, changes in life caused by alcohol and changes in the amount of alcohol consumption in the past 1 week measured with the TLFB method from pre- to post treatment (after 12 week)
Percentage of included potential participants who satisfy eligibility criteria
Subsequent dropout rate, program completion rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Recording daily alcohol consumption for a month using the web-based brief intervention program (SNAPPY-DOC)
Interventions/Control_2
Assessment only
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
Participants aged 20 years or older who are on duty or undergoing a medical examination at a work area or medical institution which have consented to cooperate on the trial
Participants who can periodically connect to the Internet and can send and receive e-mail
Participants whose AUDIT score is more than or equal to 8
Key exclusion criteria
Those who have been judged by the research director that they are not suitable for participating in the research
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takefumi |
| Middle name | |
| Last name | Ueno |
Organization
National Hospital Organization Hizen Psychiatric Center
Division name
Clinical Research Department
Zip code
842-0192
Address
Mitsu 160 Yoshinagari-cho Kanzaki-gun Saga prefecture 842-0192
TEL
0952-52-3231
uenotk@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Sunami |
Organization
Local incorporated administrative agency Saga-Ken Medical Centre Koseikan
Division name
Psychiatry
Zip code
840-8571
Address
400 Nakabaru, Kase-machi, Saga-shi, 840-8571
TEL
0952-24-2171
Homepage URL
takashisunami2010@gmail.com
Sponsor or person
Institute
National Hospital Organization Hizen Psychiatric Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Local incorporated administrative agency Saga-Ken Medical Centre Koseikan Institutional Review Board
Address
400 Nakabaru, Kase-machi, Saga-shi, 840-8571
Tel
0952-24-2171
rinrishinsa@koseikan.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
非公開
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 09 | 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
20
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
| 2019 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2021 | 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 | 04 | Month | 04 | Day |
Last modified on
| 2022 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041142
