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 2023/03/08 12:13:12

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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

Email

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


Email

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

Email

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


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

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

2022 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

2023 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047578


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name