UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057526 |
|---|---|
| Receipt number | R000065113 |
| Scientific Title | Development of a mobile app for a patient-participatory consultation for gastroenterology outpatients with a history of heavy alcohol drinking |
| Date of disclosure of the study information | 2025/04/14 |
| Last modified on | 2026/03/19 16:29:59 |
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Basic information
Public title
Development of an app to enable consultations to listen to patients dealing with alcohol issues.
Acronym
Development of an app to enable consultations to listen to patients dealing with alcohol issues.
Scientific Title
Development of a mobile app for a patient-participatory consultation for gastroenterology outpatients with a history of heavy alcohol drinking
Scientific Title:Acronym
Development of a mobile app for a patient-participatory consultation for gastroenterology outpatients with a history of heavy alcohol drinking
Region
| Japan |
Condition
Condition
chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a smartphone-based communication tool (a sobriety LINE bot), patients will be asked to record their drinking behavior and physical symptoms. The recorded information will be summarized and presented to the physician during medical consultations. This study aims to evaluate whether this tool can effectively share information about alcohol consumption and drinking frequency with the attending physician.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the accuracy of AI summary statements based on sobriety LINEbot input.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the accuracy of AI summary statements based on sobriety LINEbot input.
Key secondary outcomes
Evaluation of the accuracy of AI summary statements based on sobriety LINEbot input.
1) Weekly alcohol intake (alcohol equivalents/week) before and after 12 weeks of using the abstinence LINE bot.
2) Number of participants who remained abstinent from alcohol during the participation period / number of participants
3) Number of participants who reduced their alcohol intake by 33% or more before and after the participation period / number of participants
4) Percentage of participants who used the abstinence LINE bot (number of days abstinence LINE bot was used/number of follow-up days)
5) Whether or not the use of the abstinence LINE bot reduced the burden of medical care (questionnaire to examining physicians, VAS display)
6) Descriptive evaluation of medication compliance status if medication status is included in the summary statement.
7) Conduct a survey on the user experience of the LINE chatbot to contribute to functional improvements.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Sobriety Diary entry on the Sobriety Line bot
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
1) Patients with hepatic disease attending or hospitalized at the Department of Gastroenterology and Hepatology, KMU Medical Center, or the Department of Gastroenterology and Hepatology, Kansai Medical University Hospital.
2) Patients who are 20 years of age or older at the time of consent (regardless of gender).
3) Patients with a history of heavy drinking of alcohol. Heavy alcohol drinkers are defined here as those who drink in amounts that increase the risk of lifestyle-related diseases (net alcohol intake of 40 g or more per day for men and 20 g or more per day for women).
4) Those who have an AUDIT score of 8 or higher.
5) Those whose physician has determined that abstinence from alcohol or sobriety is necessary as treatment.
6) Those who have agreed to our sobriety intervention regarding abstinence from alcohol or sobriety.
7) Those who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the situation.
8) Those who have a smart phone with a LINE account.
Key exclusion criteria
1) Patients who are unwilling to abstain from alcohol or to sobriety
2) Patients who fail to comply with hospital admissions and outpatient visits
3) Patients who refuse sobriety interventions
4) Patients with severe mental illness other than alcohol use disorder
5) Patients who have already been diagnosed with dementia
6) Patients who have been sober for more than one year
7) Other patients deemed inappropriate as research subjects by the principal investigator
8) Patients who cannot consent to the use of the experimental specification communication application (LINE) on their smart phones
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Noriyo |
| Middle name | |
| Last name | Yamashiki |
Organization
Kansai Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
573-1010
Address
2-5-1 Shin-machi, Hirakata City, Osaka
TEL
072-804-0101
yamashiki.nor@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Noriyo |
| Middle name | |
| Last name | Yamashiki |
Organization
Kansai Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
573-1010
Address
2-5-1 Shin-machi, Hirakata City, Osaka
TEL
072-804-0101
Homepage URL
yamashiki.nor@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Noriyo Yamashiki
Funding Source
Organization
Japan Society for the Promortion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Science and Technology, Nara Institute of Science and Technology (NAIST);
Division of Drug Informatics, Keio University Faculty of Pharmacy
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Ethical Review, Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata, Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 04 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065113
