UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041680 |
|---|---|
| Receipt number | R000047578 |
| Scientific Title | A randomized controlled trial of a self-monitoring smartphone app for reducing risky alcohol drinking |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2025/03/09 20:27:53 |
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Basic information
Public title
Evaluation of a smartphone app for self-monitoring alcohol use
Acronym
Evaluation of a smartphone app for self-monitoring alcohol use
Scientific Title
A randomized controlled trial of a self-monitoring smartphone app for reducing risky alcohol drinking
Scientific Title:Acronym
A randomized controlled trial of a self-monitoring smartphone app for reducing risky alcohol drinking
Region
| Japan |
Condition
Condition
Risky alcohol drinking
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of a self-monitoring smartphone app for reducing risky alcohol drinking
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Alcohol consumption per day in the past week at 8-week follow-up (immediately after the intervention): the TimeLine Follow Back method (TLFB)
Key secondary outcomes
1. Alcohol consumption per day in the past week at 4- and 24-week follow-up: the TLFB
2. The number of alcohol drinking days during the intervention period (56 days): the TLFB
3. Continuance of abstinence: the TLFB
4. Behavioral change: the Japanese version of the University of Rhode Island Change Assessment Scale.
5. Mental health: The General Health Questionnaire-30.
6. Health related QOL: the SF-8.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self-monitoring utilizing a smartphone app for 8 weeks
Interventions/Control_2
Provision of information regarding risky alcohol drinking for 8 weeks
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
1. Risky alcohol drinkers (AUDIT score 8 to 19 points)
2. Those who own a smartphone
3. Those who can communicate via email
4. Those aged 20 years or older
Key exclusion criteria
1. Those who cannot read/write in Japanese
2. Those who unable to access the internet or complete online questionnaires
3. Those who cannot participate in this study for 6 months
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Takano |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences, Department of Mental Health and Psychiatric Nursing
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo
TEL
03-5803-5348
ayumi-takano@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Takano |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences, Department of Mental Health and Psychiatric Nursing
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo
TEL
03-5803-5348
Homepage URL
ayumi-takano@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental 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
Medical Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.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
・東京医科歯科大学（東京都）/ Tokyo Medical and Dental University (Tokyo)
・独立行政法人国立病院機構 久里浜医療センター（神奈川県）/ National Hospital Organization Kurihama Medical and Addiction Center (Kanagawa)
・国立研究開発法人 国立精神・神経医療研究センター（東京都）/ National Center of Neurology and Psychiatry (Tokyo)
・株式会社 ヒューマノーム研究所（東京都）/ Humanome Lab., Inc. (Tokyo)
・東京理科大学（東京都）/ Tokyo University of Science (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | 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
256
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It is taking time for data analysis.
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047578
